Symptoms and General Pathology

All Conditions

Recurrence

Disease Attributes

Participants in the eConquerFear-HK intervention group will receive six online modules with each containing educational text, illustrative graphics, interactive exercises, and brief videos. Every module will teach a specific topic, such as self-examination and medical surveillance, values-based goal setting, attention training, detached mindfulness, worry management and treatment summary and relapse prevention.

Participants in the control group will receive six videos, which were designed to provide comprehensive lifestyle guidance (e.g., relaxation techniques, diet and physical activity advices) to help with survivors' maintenance of health in long-term.

The key goals of the intervention are to: (i) teach strategies for controlling worry and excessive threat monitoring; (ii) modify underlying unhelpful MCQ beliefs about worry; (iii) develop appropriate monitoring and screening behaviours, (iv) encourage acceptance of the uncertainty brought about by a cancer diagnosis, and (v) clarify values and encourage engagement in values-based goal setting.

eConquerFear-HK

Basic Cancer Care serves as an active comparator and is not developed specifically to target fear of cancer recurrence through modifying participants' cognitive beliefs. Participants in this arm will receive 6 videos about relaxation, generic dietary and exercise knowledge.

Basic Cancer Care

Danielle Ng, PhD

Dominic Foo

The present study aims to adapt a metacognition-based ConquerFear-HK to an internet-based self-management intervention, namely eConquerFear-HK and evaluate in a randomised controlled trial, its feasibility, utility, and potential effectiveness on fear of cancer recurrence reduction among local Chinese cancer survivors with subclinical fear of cancer recurrence.

A pilot randomised controlled feasibility trial will used to test the feasibility, utility, and potential effectiveness of an internet-based self-management intervention for fear of cancer recurrence among local Chinese cancer survivors with subclinical fear of cancer recurrence.

The following hypotheses will be tested:

1. There will be a greater FCR improvement in cancer survivors receiving eConquerFear-HK intervention vs those in the active control group.
2. There will be a greater MCQ reduction in cancer survivors receiving eConquerFear-HK intervention vs those in the active control group.
3. There will be greater improvements in secondary outcomes (psychological distress and quality of life) in cancer survivors receiving eConquerFear-HK intervention vs those in the active control group.
4. Cancer survivors receiving eConquerFear-HK intervention will perceive the intervention useful for managing their FCR and be satisfied with the intervention.
5. Cancer survivors receiving eConquerFear-HK intervention will show high completion rates.

A prospective, parallel RCT design will be used to assess the impact of the eConquerFear-HK intervention on FCR improvement among Chinese cancer survivors in Hong Kong. Participants will be randomly assigned to an intervention group or a control group at a 1:1 ratio, using a computer-generated block randomization sequence generated by a statistician who is blinded to the identity of participants. This allocation concealment approach minimizes risk of selection and assessment bias. The serially labelled opaque sealed envelope method will be used for randomization. Block randomization structure with randomly permuted blocks sizes of 2 and 4 will be used to ensure close balance of numbers in each arm.

The investigator, care provider, and outcomes assessor are masked in terms of not knowing to which condition the participants will be randomized until after the completion of the baseline assessment. The outcomes assessor will break the envelope for the next eligible participant indicating if that participant is to be allocated to the intervention or control arms.

The participants are masked in terms of not knowing that the intervention, eConquerFear-HK are hypothesized to yield larger effects than the other (i.e. control).

E-intervention on Subclinical Fear of Cancer Recurrence

Conquering Fear Online: a Pilot Randomised Controlled Trial Assessing the Efficacy and Feasibility of an Internet-based Self-management Intervention on Subclinical Fear of Cancer Recurrence

All IPD that underlie results in a publication will be available from the PI upon reasonable request.

number of participants consent and being randomized/number of eligible patients x 100

number of participants who complete follow-up assessments at 3 and 6 months post-baseline/number of participants enrolled x 100

number of participants who complete the intervention/number of being allocated to attend the intervention x 100

Intervention utility will be assessed using the site use metrics, including total number of log-ins

Acceptability of the intervention will be assessed using the 22-item measure, which was adopted from the 31-item measure designed to assess the general views on the presentation and content of information in a decision aid intervention for treatment decision making. It assess the comprehensibility of the intervention content and also its utility using 4- (1 = "Poor"; 2 = "Fair"; 3 = "Good"; 4 = "Excellent") or 5-option (1 ="strongly disagree"; 5 = "strongly agree") categorical responses, respectively. Higher scores indicate better acceptability.

Fear of cancer recurrence. FCR will be assessed using the Chinese 42-item Fear of Cancer Recurrence Inventory (FCRI) at four assessment points (T0-T3).(5) FCRI comprises seven subscales: trigger, severity, psychological distress, functional impairment, reassurance, insights and coping strategies measured using 5-point Likert scales (0 = "never"; 4 = " a great deal or all the time").(5) Total scores range from 0 to 168; with higher scores indicating higher FCR.

Quality of life will be measured by the Chinese version of the 30-item European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30), consisting of five functional subscales (physical, role, emotional, cognitive, and social functioning), three symptom subscales (pain, fatigue and nausea/vomiting), a global health subscale, five single symptom items (e.g., sleep disturbance, dyspnea, appetite loss, constipation, and diarrhea), and an single item for financial difficulty. The score range is 0-100. High scores on the functional and global health subscales indicate better functioning and QoL, respectively. High scores on the symptom subscale or item indicate more symptom(s).

e Chinese 14-item Hospital Anxiety and Depression Scale (HADS),(21) comprising two 7-item subscales that measure anxiety and depression. Each subscale total scores range from 0 to 21 with higher scores suggesting higher distress.

Attitude towards internet will be assessed using a 6 points-categorical Likert scale (0-5) asking if they find internet easy to use. Higher scores indicate more positive attitude towards internet.

A 17-item treatment satisfaction questionnaire, originally designed to evaluate overall satisfaction with the intervention in our current RCT of ConquerFear-HK, will be used. The first 9 items will be assessed using a 5 points-categorical Likert scale (1-5) Higher scores indicate higher satisfaction. The remaining questions are open-questions.

Metacognition will be assessed at T0-T3 using the 30-item Metacognitions Questionnaire- 30 (MCQ-30), consisting of five subscales assessing Positive beliefs about worry, Negative beliefs about worry, Cognitive Self-Consciousness, Cognitive Confidence, and Need to control thoughts. A 4 points-categorical Likert scale (1-4) will be used. Higher scores indicate worse metacognition

Health and Medical Research Fund

The University of Hong Kong

Neoplasms

Skin and Connective Tissue Diseases

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

It has been established that chronic stress can take a toll on one's health. Furthermore, when an someone falls ill, it is believed that the way that they handle stress and/or adversity can positively or negatively impact the course of their disease. Against the background of these findings, this study aims to explore how (1) cumulative lifetime stress exposure, (2) coping response, (3) perceived social support, and (4) and overall psychological well-being may relate to the oncological outcomes of women diagnosed with triple negative breast cancer (TNBC).

Patients treated for TNBC between 01.01.2015-31.12.2019 at the University Clinic for Gynecology at Pius-Hospital Oldenburg will be asked to complete four questionnaires corresponding to the abovementioned psychological aspects. The results of these questionnaires will be analyzed together with the clinical patient data and tumor characteristics (such as type, size, etc.) to explore whether there is a tendency between one or more of the above-mentioned psychosocial aspects and the course of the disease (e.g. a disease recurrence within one year after the initial diagnosis (yes / no), the duration of the disease-free or progression-free period).

As there is an existing body of evidence supporting a relationship between stress and the immune system, we expect to see the poorest oncological outcomes in patients who 1) have faced more stressful/adverse life events, 2) those who present inadequate/inappropriate coping skills, 3) report less social support, and 4) poorer overall psychological well-being.

If a potential connection between psychosocial factors and the course of the TNBC is identified, further disease specific, it will aid in the development of disease-specific, health-promoting measures to better support this particular patient group. This is of great importance, as TNBC is generally associated with clinically aggressive behavior and a worse prognosis compared to other breast cancer subtypes.

Triple negative breast cancer (TNBC) is a highly heterogeneous subtype, which exhibits aggressive clinical behavior and generally carries a poor prognosis. As it lacks hormone receptors expression (estrogen and progesterone receptors) and amplification of the Human epidermal growth factor receptor 2 (HER2), targeted therapies are lacking. Thus, the identification of any modifiable factors which may influence the course of the disease is critical both in improving the quality of care and the patient's quality of life. In addition to lifestyle factors, such as diet and exercise habits, psychological factors, such as cumulative lifetime stress, coping response, perceived social support, and overall psychological well-being may also influence cancer progression.

While it is known that stress can directly upregulate certain immune mechanisms, it is suspected that a patient's coping response, perceived social support, and general psychological well-being may have an indirect influence on cancer progression via altered health-related behaviors. For example, during stressful periods, alcohol consumption may rise, sleep quality may be diminished, nutritional needs may not be properly met, and exercise may be avoided. As a group, TNBC patients face additional challenges not experienced by other BC patients. Due to the disease's poor prognosis, its relatively new status as a BC subtype (first mention in 2005), and the lack of targeted treatments; patients may experience an increased stress-response following their diagnosis. For instance, it is known that an event induces a stress response when it involves novelty and unpredictability, a lack of sense of control, and threats to the sense of self; elements that are clearly emphasized in TNBC.

To promote the development of psycho oncological strategies tailored towards women in this particular patient group, this study aims to explore any trends which might be indicative of an interaction between psychological aspects and the oncological outcomes of patients treated for TNBC between 01.01.2015-31.12.2019, at Pius Hospital, in Oldenburg, Germany. Because we intend to evaluate a retrospective cohort of patients, the psychological instruments were chosen and slightly adapted to target past events (stress across life span and social support) and stable traits (psychological well-being, coping).

As there is an existing body of evidence supporting the relationship between stress and the immune system, we expect to see the poorest oncological outcomes in patients who 1) have had more adverse life events, and 2) those who present inadequate/inappropriate coping skills. Additionally, we intend to explore if other psychological variables mentioned in the literature, including perceived social support and psychological well-being, are also related to the oncological outcomes in our cohort of patients.

This study combines prospective and retrospective approaches since the psychosociological data is to be collected prospectively from a single retrospective cohort of patients. Patients could not be randomized into groups, due to the retrospective nature of the study. Considering that all data derived from this study will be numerical, this will be a quantitative analysis. This research is comparative since the patients' clinical outcomes will be analyzed in terms of psychological measures. Lastly, the present study is exploratory as it aims to shed light on the interplay between psychological and clinical aspects in TNBC, as psycho-oncological studies are lacking for this BC subtype.

A list of patient names will be obtained from the hospital's Tumor Documentation Office. Next, patient electronic medical records will be accessed through Pius-Hospital's Orbis Database program according to the name and date of birth of each patient. Demographic and clinical variables of interest will be collected from the clinical charts and recorded on the patient case report form (CRF).

The psychological aspects of interest will be assessed through self-reported questionnaires. (1 computer-based and 3 paper-based questionnaires). Patients will fill out the surveys in a proper setting where privacy will be assured. Questionnaires will not include information which could be directly used to identify participants (i.e. name, DOB), but will instead contain a code which will allow the psychological data to be combined with the respective participant's demographic and clinical variables for the subsequent statistical analysis. After completion, participant's information (pseudonymized) will be transferred to the CRF, and subsequently case data will be transferred to SPSS (software version 26.0) for further statistical analysis.

Psychological Factors and Oncological Outcomes of Triple-negative Breast Cancer

How do Psychological Factors Interact With the Oncological Outcomes of Women With Triple-negative Breast Cancer?

Cumulative lifetime stress will be quantified as a score (Overall Severity Score; OSS) derived from the Stress and Adversity Inventory (STRAIN) questionnaire (Slavich and Shields, 2018).

University of Oldenburg

Pius-Hospital Oldenburg

Clinic Director

Participants in the ConquerFear intervention group will receive a manualized intervention, consisting of 6 therapist-led individual sessions.

Basic Cancer Care serves as an active comparator and is not developed specifically to target fear of cancer recurrence through modifying participants' cognitive beliefs. Participants in this arm will receive 6 individual sessions including 2 relaxation training sessions, 2 dietetic consultation sessions, and 2 exercise sessions, which will be led by a trained therapist, a registered dietitian, and an exercise physiologist, respectively.

ConquerFear is a manualized intervention, consists of six individual sessions over 10 weeks. The key goals of this intervention are the following: (1) teach strategies for controlling worry and excessive threat monitoring, (2) modify underlying unhelpful beliefs about worry, (3) develop appropriate monitoring and screening behaviours, (4) encourage acceptance of the uncertainty brought about by a cancer diagnosis, and (5) clarify values and encourage engagement in values-based goal setting (19). Each session will last 60-90 minutes and be delivered by a trained therapist. After each session, participants will be given home-based exercises to practice the skills learned in the sessions. With the uncertainty surrounding the COVID-19 pandemic, instead of face-to-face sessions only, a hybrid mode of intervention delivery will be used by offering participants the choice of face-to-face or online sessions.

ConquerFear Intervention

Basic Cancer Care intervention for the control arm was developed to help cancer survivors with health maintenance in long-term through providing comprehensive lifestyle guidance. The intervention incorporates relaxation training, dietary and physical fitness consultations with the key goals to (1) teach relaxation techniques, (2) offer personalized diet and physical activity advice, and (3) enhance survivors' perceived control over illness, thereby leading to better adjustment to cancer. Similar to the ConquerFear intervention, Basic Cancer Care intervention consists of 6 individual sessions over 10 weeks. Each session will last 60-90 minutes and be delivered by a trained therapist, a registered dietitian, and an exercise physiologist, respectively. A hybrid mode of intervention delivery will be also used by offering participants the choice of face-to-face or online sessions.

Active control: Basic Cancer Care

Wendy Wing Tak Lam, PhD

The primary aim of this study is to assess the effect of ConquerFear, a metacognition-based manualized intervention on fear of cancer recurrence, using the randomized controlled trial approach, among Chinese patients newly diagnosed with curable cancer. This study aims to (1) test the direct effect of ConquerFear intervention on fear of cancer recurrence and on maladaptive metacognition, and (2) to test the indirect effect of ConquerFear intervention on fear of cancer recurrence through its effect on maladaptive metacognition.

A randomized controlled trial will be conducted to test the effect of a metacognition-based manualized intervention on fear of cancer recurrence among Chinese breast, gynecologic and colorectal cancer patients with high levels of fear of cancer recurrence.

The aims are to test:

1. the direct effect of ConquerFear intervention on fear of cancer recurrence,
2. the direct effect of ConquerFear intervention on maladaptive metacognition
3. the indirect effect of ConquerFear intervention on fear of cancer recurrence through its effect on maladaptive metacognition.

Primary hypothesis:

1. Participants in the ConquerFear intervention will show a greater reduction in fear of cancer recurrence compared to participants in the control group
2. Participants in the ConquerFear intervention will show a greater reduction in maladaptive metacognition than the control participants
3. There will be an indirect effect of ConquerFear intervention on fear of cancer recurrence through its effect on maladaptive metacognition.

We will use a block randomization structure with randomly permuted block sizes of 2,4, and 6 to ensure a close balance of the numbers in each arm. Randomization (by a statistician) occurs prior to eligible patients attending the clinic to minimize opportunities for selection bias.

We will also use a block randomization structure with randomly permuted block sizes of 4 and 8 to ensure an equal case allocation to each therapist.

We will also use a block randomization structure with randomly permuted block sizes of 2,4, and 6 to ensure an equal case allocation to each dietitian.

The investigator, care provider, and outcomes assessor are masked in terms of not knowing to which condition the participants will be randomized until after the completion of the baseline assessment. The outcomes assessor will break the envelope for the next eligible participant indicating if that participant is to be allocated to ConquerFear or control arms.

The participants are masked in terms of not knowing that one intervention (i.e. Conquer fear) is hypothesized to yield larger effects than the other (i.e. control).

The Effect of Metacognition-based, Manualized Intervention on Fear of Cancer Recurrence

The Effect of Metacognition-based, Manualized Intervention on Fear of Cancer Recurrence: a Randomized Controlled Trial

Demographic data including age, gender, marital status, education level, occupation and monthly family income will be assessed by self-reported questionnaire

Clinical data will be extracted from medical records.

The 42-items Fear of cancer recurrence inventory comprised of seven subscales will be used to assess the change of fear of cancer recurrence (FCR). Each item is rated on a 5-point Likert Scale with a total score ranging from 0 to 168. Higher scores indicate greater FCR. The subscale, Severity will be used as a screening tool for high level of FCR. A score of 13 or higher was optimal for screening.

The 30-items Metacognitions questionnaire (MCQ-30) will be used to assess the change of metacognitive beliefs.Each item is rated on a 4-point Likert scale with a total score ranging from 30 to 120. High scores indicate a more maladaptive metacognitive style.

Quality of life (QoL) will be assessed by the EORTC QLQ-C30, in which incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhoea) and perceived financial impact of the disease.

Self-efficacy for managing chronic disease will be assessed using the Self-Efficacy for Managing Chronic Disease 6-item Scale.

Coping behavior will be assessed using the 28-item Chinese Brief COPE.

Experimental avoidance will be assessed using the Acceptance and action questionnaire.

Cognitive Attentional Syndrome (CAS) will be assessed using the Cognitive-attentional Syndrome questionnaire (CAS-1).

Intolerance of uncertainty (IU) will be assessed using the 12-item Intolerance of uncertainty-12.

Psychological distress will be assessed using the Hospital Anxiety and Depression Scale (HADS). HADS is a 14-item measure of anxiety and depression widely used to assess cancer-related distress.

The 22-item Chinese Impact of Events Scale-revised (CIES-R) will be used to assess cancer-related distress, which comprised three subscales: avoidance, intrusive thoughts and hyperarousal symptoms measured using 5-point Likert scales. Higher mean scores on each subscale indicate greater avoidance/intrusiveness/arousal.

Treatment expectancy will be assessed using the 6-item credibility/ expectancy questionnaire.

The 12-item Working Alliance Inventory (WAI-SF)will be used to assess agreement on the therapy goal, patients' agreement with the therapist, and quality of the interpersonal bond. Both the participants and therapists will be asked to fill in the WAI-SF immediate post-intervention

Treatment satisfaction will be assessed using the evaluation form. Participants will be asked to indicate their overall satisfaction with the intervention they have received.

Research Grants Council, Hong Kong

Associate Professor

Participants in the eConquerFear intervention group will receive six online modules with each containing educational text, illustrative graphics, interactive exercises, and brief videos. Every module will teach a specific topic, such as self-examination and medical surveillance, values-based goal setting, attention training, detached mindfulness, worry management and treatment summary and relapse prevention.

Participants in the eHealthMaintenance group will receive six videos, which were designed to provide comprehensive lifestyle guidance (e.g., relaxation techniques, diet and physical activity advices) to help with survivors' maintenance of health in long-term.

ConquerFear-HK is a culturally adapted, manualized intervention consisting of 6 individual face-to-face sessions over 10 weeks.

The augmented eConquerFear + eHealthMaintenance intervention is a combined unsupervised, self-guided web-based intervention that consists of 10 weekly online modules covering the content of eConquerFear and eHealthMaintenance interventions.

The key goals of this e-intervention are to: (i) teach strategies for controlling worry and excessive threat monitoring; (ii) modify underlying unhelpful MCQ beliefs about worry; (iii) develop appropriate monitoring and screening behaviours, (iv) encourage acceptance of the uncertainty brought about by a cancer diagnosis, and (v) clarify values and encourage engagement in values-based goal setting.

eConquerFear

eHealthMaintenance is not developed specifically to target fear of cancer recurrence through modifying participants' cognitive beliefs. Participants in this arm will receive 6 videos about relaxation, generic dietary and exercise knowledge.

eHealthMaintenance

ConquerFear is an intensive version of eConquerFear, which consists of 6 face-to-face therapist-led sessions.

ConquerFear

The combination of eConquerFear and eHealthMaintenance interventions, that consists of 10 weekly online modules.

eConquerFear+eHealthMaintenance

Wendy Lam, PhD

A sequential multiple-assignment randomized controlled trial (SMART) will be used to assess the effect of an adaptive stepped-care intervention on FCR in cancer survivors with subclinical levels of fear of cancer recurrence.

The current SMART trial aims to address the following hypotheses:

Hypothesis 1: It is better to begin adaptive interventions with eConquerFear than with eHealthMaintenance.

Hypothesis 2: Among initial non-respondents, it is better to switch to supervised, face-to-face ConquerFear than to augment eConquerFear with eHealthMaintenance.

Hypothesis 3: eConquerFear + ConquerFear will lead to the greatest reduction in fear of cancer recurrence.

Hypothesis 4: There would be an indirect effect of stepped-care ConquerFear intervention on fear of cancer recurrence through its effect on maladaptive metacognition and cognitive attentional syndrome.

First stage intervention: We will use a block randomization with randomly permuted block sizes of 2,4, and 6 to ensure close balance of the numbers in each arm. Participants will be randomised to the eConquerFear or eHealthMaintenance

Second stage intervention for non-respondents: We will use a block randomization with randomly permuted block sizes of 2,4, and 6 to ensure close balance of the numbers in each arm. Participants will be randomised to the augment eConquerFear with eHealthMaintenance (or vice versa) versus switch to supervised, face-to-face ConquerFear intervention.

he investigator, care provider, investigator and outcomes assessor are masked in terms of not knowing to which condition the participants will be randomized until after the completion of the baseline assessment. The outcomes assessor will break the envelope for the next eligible participant indicating if that participant is to be allocated to intervention or control arms.

The participants are masked in terms of not knowing that one intervention is hypothesized to yield larger effects than the other.

The Effect of a Stepped-care Metacognition-based Intervention on Managing Fear of Cancer Recurrence

The Effect of a Stepped-care Metacognition-based Intervention on Managing Fear of Cancer Recurrence: Sequential, Multiple Assignment, Randomized Controlled Trial (SMARTs)

The primary outcome is the change in the total score of FCR assessed using the 42-item Fear of Cancer Recurrence Inventory (FCRI). The FCRI measures seven dimensions of FCR: (1) triggers, (2) severity, (3) psychological distress, (4) functional impairment, (5) reassurance, (6) insights, and (7) coping strategies. All items are rated on 5-point Likert scales ranging from 0 (not at all or never) to 4 (a great deal or all the time). Higher scores indicate higher levels of FCR.

Metacognition assessed by the 30-item Metacognitions Questionnaire (MCQ). The MCQ assesses individual differences in metacognitive beliefs, judgements, and monitoring tendencies across five domains: (1) positive beliefs about worry, (2) negative beliefs about thoughts concerning uncontrollability and danger, (3) cognitive confidence, (4) cognitive self-consciousness, and (5) the need to control thoughts. All items are rated on a 4-point Likert scale ranging from 1 (do not agree) to 4 (agree very much). Higher scores indicate higher levels of maladaptive metacognition.

CAS measured by the 16-item Cognitive Attentional Syndrome-1 (CAS-1) questionnaire.The CAS-1 assesses the frequency of engaging in rumination, threat monitoring, and coping behaviors, as well as the level of metacognitive beliefs. Each item is rated on a 9-point Likert scale ranging from 0 to 8, except for items measuring metacognitive beliefs, which are rated on a scale from 0 to 100. Higher scores indicate higher levels of CAS activation.

Neoplasm Metastasis

Disease Progression

Neoplastic Processes

Participants in the CALM intervention group will receive a semi-structured, manualized, individual psychotherapy intervention consisting of 3-6 individual therapy sessions.

ConquerFear intervention

CALM is a semi-structured, manualized, individual psychotherapy intervention designed for patients with advanced cancer. It includes 3-6 individual therapy sessions, with each approximately lasts 45-60 minutes, delivered over 3-6 months. The sessions cover 4 domains: 1) symptom management and communication with health care providers; 2) changes in self and relations with close others; 3) sense of meaning and purpose; and 4) the future and mortality. All modules will be addressed with each patient, but the sequencing and time devoted to each domain can be varied, based on the concerns that are most relevant to each patient.

CALM intervention

Danielle Wing Lam Ng, PhD

Karen Chan

Wendy Chan

Ava Kwong

The present study aims to conduct a randomized controlled trial to assess the effect of CALM intervention and ConquerFear intervention on fear of cancer progression among Chinese patients diagnosed with advanced cancer.

A randomized controlled trial will be conducted to assess the effect of CALM intervention and ConquerFear intervention on fear of cancer progression among Chinese patients diagnosed with advanced cancer.

The aims are to test:

1. the direct effect of CALM intervention or ConquerFear intervention on fear of cancer progression, and
2. the indirect effect of ConquerFear intervention on fear of cancer progression through its effect on maladaptive metacognition.

Primary hypothesis:

1. Patients receiving CALM intervention or ConquerFear intervention, compared to those receiving a basic cancer care intervention will show a reduction in fear of cancer progression.
2. Both CALM intervention and ConquerFear intervention will be equally effective in reducing fear of cancer progression.
3. Given ConquerFear intervention aims to modify unhelpful metacognitive beliefs, there will be an indirect effect of ConquerFear intervention on fear of cancer progression through its effect on maladaptive metacognition.

The investigators will use a block randomization structure with randomly permuted block sizes of 3 and 6 to ensure a close balance of the numbers in each arm. Randomization (by a statistician) occurs prior to eligible patients attending the clinic to minimize opportunities for selection bias.

The investigator, care provider, and outcomes assessor are masked in terms of not knowing to which condition the participants will be randomized until after the completion of the baseline assessment. The outcomes assessor will break the envelope for the next eligible participant indicating if that participant is to be allocated to ConquerFear or CALM or control arms.

The participants are masked in terms of not knowing that the interventions (i.e. Conquer fear and CALM) are hypothesized to yield larger effects than the other (i.e. control).

Managing Fear of Cancer Progression Metacognition-based Vs Supportive-expressive Based Approaches

Managing Fear of Cancer Progression Metacognition-based Vs Supportive-expressive Based Approaches: A Randomized Controlled Trial

The 12-item short version of the Fear of Progression Questionnaire (FoP-Q-SF) will be used to assess the change in total score of fear of caner progression. Each item of the FoP-Q-SF is rated on 5-point Likert scales anchored at 1 (Never) to 5 (very often). Higher scores indicate higher levels of fear of cancer progression. Total scores range from 12 to 60. A cutoff of 24-33 was used to suggest subthreshold level of fear of progression and a score of 34 or greater suggest high levels of fear of progression.

Change in total scores of depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 score can range from 0 to 27, with higher scores indicative of a higher level of depression. The PHQ-9 is a reliable and valid 9-item measure of depression that has been used widely in advanced cancer patients.

Change in total scores of death anxiety will be assessed by the 15-item Death and Dying Distress Scale (DDDS). The DDS score can range from 0 to 90, with higher scores indicative of a higher level of death anxiety.

Behaviors and Mental Disorders

Depressive Disorder

Depression

Participants can work on ten modules specialized cognitive behavior treatments to learn and deal with mindfulness, acceptance and commitment. They should learn to handle their emotions, to accept the situation and to get in an active future. The participants can direct contact a psychotherapist via email, Chat or Skype/tokbox. The modules based on Cognitive Behavior Therapy.

Participants can work on six modules with information und education goals for learning something about their possibilities to become a better mood, better psychovegetative or psychosocial situation as cancer patient. This modules are based on Cognitive Behavior Therapy. The non-intervention arm will only allow contact to the platform, no direct contact to a psychotherapist (in opposite to the intervention arm) is available.

treatment technique to help people to overcome psychological distress and mental diseases

cognitive behavior therapy

Peter Tonn, MD

Silja C. Reuter, MD

Nina Schulze, MoS

Cancer patients develop a high psychological burden of the underlying disease. To support patients in outpatient phases psychotherapists are not sufficiently available for establish regularly face-to-face-contact. The availability of Internet-based psychotherapeutic support can bridge this gap. This study examines the effectiveness of MAC-CBT® via the Internet (called Incobeth®) in cancer patients.

In this study, a randomized trial is conducted in which the online users are allocated into two different care services (MAC-CBT® vs. psycho-educational support program). Participants are cancer patients who have been advised by their treating oncologists, family doctors or psychotherapists on the online support. All patients are randomized, based on the information the referring physician give about type of tumor, treatment status, prognosis and psychosocial factors. Initial will be done an extensive psychometric survey. The MAC-CBT® group receives an intervention program based on ten modules, in which the aspects of Mindfulness, Acceptance and Commitment in detail are included to start a process-oriented self-treatment with regular feedback by the individually assigned psychologists through the internet-portal and email and through live contacts (via video-telephony). The control group will have access to six modules with a psychoeducational support program, which is also constructed according to the MAC principle. Both groups can use crisis modules (in case of pain, psychological crisis, fear of dying) without access restriction. The control group, upon completion of 6 weeks (for each module one week) can switch to active treatment arm. Input and output results are determined using validated survey instruments. Randomisation is done by a physician not involved in the further course of the evaluation.

Internet-delivered Psycho-oncological Support

MAC-CBT Used as Internet-delivered Psycho-oncological Support

Recording of change of score PRIME-MD, depression, anxiety and other mental health issues

Measurement of the changes of quality of life after the treatment

Reflection of the changes of resilience to test if it is stable or fluid over the treatment period

University of Hamburg-Eppendorf

Neuropsychiatrischen Zentrums Hamburg-Altona

Managing director of the Department

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Death

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Quality of Life

Patients will be monitored allowing the delivery of timely and personalized care via a 4-level program:

1. Screening and psychosocial monitoring through a mobile application where patients have a messaging system to contact their psychologist and reference nurse.
2. Psychoeducation and health education campus, where patients can consult videos and online resources developed by health professionals, containing scientifically validated information.
3. Psychosocial support community where patients can share doubts, fears, and experiences with other patients with advanced lung cancer. This private social network is monitored by team specialists when necessary.
4. Online group psychotherapy of 8 weekly sessions of 90 minutes based on Meaning-Centered Group Psychotherapy (MCGP; Breitbart et al., 2010). Patients at this level will be on a waiting list, so the pool starts when there are 4-8 users available.

This group will receive standard psychosocial care for cancer survivors at ICO Hospitalet center led by a clinical psychologist. It consists of 7 individual sessions of 45-60 minutes, scheduled every 2-3 weeks during 9 months and focused on emotional support and psychoeducation. Moreover, they will be offered the education materials from the 2nd step of the platform, as they are compiled in a website open to all patients and relatives.

1. Screening and monitoring: weekly administration of an emotional state thermometer. If the score is \>5, participants are asked to complete the HADS. If HADS' score \>10, step 2 is assigned. The same procedure is followed for steps 3 \& 4. Participants remain in each step for 2 weeks, and all level changes are preceded by a videoconference with a health professional
2. Online psychoeducation campus: displays co-constructed videos and posts developed by health professionals and patients about LC diagnosis and treatment aspects.
3. Online support community: anonymous survivors with LC diagnoses are included. Professionals and patient mentors supervise and foster debate, peer support, and resolve health Q\&As.
4. Weekly online group psychotherapy led by a clinical psychologist and composed of eight 90-minute sessions. Eligible users are placed on a waiting list, starting when 5-6 users are available.

E-health ecosystem of stepped psychosocial care

Usual psychosocial care for cancer survivors at ICOHospitalet centre led by a clinical psychologist. Usual psychosocial care consists of 7 individual sessions of 45-60 minutes, with 2-3 weeks of space between sessions, based on Individual Meaning-Centered Psychotherapy (IMCP) for Patients With Advanced Cancer (Breitbart et al., 2012). Moreover, they will be offered the education materials from the 2nd step of the platform, as they are compiled on a website open to all patients and relatives.

Usual psychosocial care

Maria Serra Blasco, PhD

Cristian Ochoa, PhD

Being diagnosed with cancer impairs many areas of a person's life. Although efficacious educational, emotional and social interventions exist in this regard, they often reach few survivors and late. This project, carried out by a specialized centre in cancer care and health research, will study the effectiveness, costs, and utility associated with a digital ecosystem tailored to meet the needs of patients with advanced lung cancer. This solution bridges the gap between patients and professionals to offer health services precisely when they are needed. The project is developed in the first year of an advanced lung cancer diagnosis, comparing the effects of the digital ecosystem with usual care in terms of their capacity to improve various psychosocial indicators. A comparative economic analysis will be carried out as well, to prove the cost-utility of the digital ecosystem presented.

Palliative Care (PC) for patients with advanced life-limiting diseases and the management of their symptoms during the trajectory of illness has evolved considerably (Clark, 2007). PC is conceptualized as an approach to improve the quality of life of patients and their relatives "through the prevention and relief of suffering by means of early identification and impeccable assessment and treatment of pain and other physical, psychosocial and spiritual problems". In recent years, survival rates have increased for most cancer diagnoses, in both early and advanced stages. Therefore, patients suffering a disease considered incurable are living longer with cumulative psychosocial comorbidity derived from both the illness itself and its associated treatments. The American and European societies for medical oncology have recently recommended integrating early psychosocial PC into standard oncological practice for patients with metastatic or advanced stage diseases like lung cancer (LC) in their professional guidelines. This decision has been recently supported by meta-analytic results as well. Those studies show that palliative interventions including physical and psychological aspects have beneficial effects on patients, both on short-term quality of life and in general symptom burden.

Despite the advantages of such integrated PC interventions, healthcare systems usually encounter several barriers to implementing psychosocial care in palliative settings, like in advanced LC. The most typical include poor early detection of such needs; long waiting lists; and mobility restrictions, with many patients unable to attend visits in person. The literature strongly suggests that emotional distress is associated with worse quality of life, lower adherence to oncological treatments and adoption of unhealthy lifestyles. Actually, it is also demonstrated that stress reduction may even extend survival years. Since LC patients show great symptom variability, erratic evolution and high emotional impact along with a limited prognosis, it is urgent to increase the currently small proportion of patients with early screening, close and intensive monitoring and prompt referral to PC teams. To this aim, new approaches in psychosocial PC are needed to overcome the barriers experienced today.

In the last years, two main actions have been proposed to improve the implementation of psychosocial care in PC, placing a focus on its accessibility and efficiency. For example, recent studies have introduced earlier stepped (low to high intensity) and adaptive treatments as an ingenious and sensible response to the challenge of offering proper psychosocial interventions, with high cost-effectiveness in cancer. Another comprehensive action is to make use of Information and Communication Technologies (ICT). ICT has emerged in the last few years as an innovative resource to set this new wave of health practices in motion, with an exponential increase in its use and implementation during the COVID pandemic, to guarantee continuity of care in vulnerable advanced cancer patients. ICT have also shown their capability to overcome most of the limitations expressed in conventional care settings. These tools have provided faster and more intense follow-up options to monitor patients' warning signs, facilitating better communication between patients and professionals, and also leveraging cheaper and more accessible clinical treatments compared to traditional alternatives, even at the end of life. Nevertheless, the few studies comparing ICT and usual psychosocial interventions have found mixed effectiveness results so far.

Recently, ONCOMMUN, a European proposal for creating an e-health ecosystem (https://oncommun.eu/), has combined these two promising actions to facilitate early psychosocial care in an online and stepped psychosocial program. ONCOMMUN has shown promising preliminary results on breast cancer (BC) and a high potential for therapeutic application in advanced and palliative settings, like LC. The first level of care in this program is an online screening and monitoring tool, followed by a patient's campus comprising educational interventions (second level), a psychosocial support community (third level), and psychotherapeutic treatment groups through videoconference (fourth level).

The current project has been designed as a randomized non-inferiority controlled trial to compare an e-health ecosystem of psychosocial care, based on the ONCOMMUN proposal, against traditional in-person psychosocial treatment in PC during advanced LC. Our group proposes the development and adaptation of this digital ecosystem by integrating screening and monitoring tools with educational and psychological interventions, building upon the results of its recent implementation in BC. This innovative e-health ecosystem intends to foster healthy experiences, integrating a four-stepped psychosocial program of early PC focused on patients with a diagnosis of non-small cell lung carcinoma (NSCLC) at advanced stages (III and IV).

OBJECTIVES (3 years)

General

1. To offer early detection and tailored treatment of psychosocial and physical needs of advanced LC survivors.
2. To implement and assess an online stepped ecosystem for psychosocial and educational screening, monitoring and care, through the use of an e-health platform specifically developed for advanced LC patients.

Specific objectives

1. To compare the capacity of the digital ecosystem to detect and deliver early psychosocial care compared to treatment as usual.
2. To improve or cushion the consequences of the advanced lung cancer course and treatment in terms of emotional distress, demoralization and quality of life.
3. To explore the potential mediating and facilitating role of spirituality in an optimal psychosocial adaptation.
4. To study the cost-utility associated with both interventions in terms of Quality-Adjusted Life Years (QALY), through the estimation of patients' use of additional health services, their degree of pharmacological adherence, intake of psychotropic medication, and time spent in disability leaves.
5. To disseminate to cancer patients, professionals and the general public the results of the study.

Procedure and data acquisition

1. Development of an LC platform: LC platform will be adapted from the BC platform and fed by the results of the pilot LC system and focus groups with professionals and patients. The LC solution will share a set of structural items (e.g., measurement instruments, instant symptom management), to which specific resources for LC will be added. Patients' experience will be at the centre of this development stage to maximize usability and understanding of all resources.
2. Validation with users: Patients with advanced LC diagnosis will be invited to participate by their medical team. If interested, they will be contacted by our group and a face-to-face meeting will be scheduled, where the study will be described and informed consent signed in case of acceptance. Participants will be then randomized to 1) e-health ecosystem or 2) usual psychosocial care by an external researcher blind to the research questions and treatment conditions, using a random sequence of numbers generated by REDCap software. In the eHealth ecosystem group, participants lacking equipment will be offered webcams and tablets as needed. There are specific processes of the system that will only apply to ICOnnecta't branch as they will measure the platform usability and their associate emotional state during the study (see Interventions section below). All other measures will be administered from T0 to T3 through a professional online survey platform compliant with the latest European General Data Protection Regulation (GDPR; EC/2016/679).

Data collection and analysis

Two databases will be created: The first one will associate participants' identifiable personal data (e.g., names, patient ID) with an alphanumeric code, and will be saved in an encrypted external hard drive stored in a key-protected closet within the office of the PI. The second database, created via REDCap system, will record all data to be analyzed making use of alphanumeric codes and will be stored in a secure collaborative cloud also GDPR-compliant. This procedure will allow us to conduct the analyses anonymously. Data will be monthly downloaded from REDCap and backed up in a second encrypted external hard drive. Every 3 months one researcher will conduct a data integrity check. While online systems automatically keep a registry of users' access, a notebook will remain next to the hard drives for researchers authorized by PIs to record their name, date and time when drives are retrieved and returned. Finally, the information collected through the eHealth ecosystem will also be stored in a GDPR-compliant server.

Descriptive results will be provided for sociodemographic and clinical variables, as well as for education, usability and satisfaction indicators, while between-group differences will be assessed with Student's t-test and chi-square tests as appropriate. Multilevel linear models (MLM) will be used to compare both groups in outcome variables, while effect sizes (Hedges' g) will be reported and non-inferiority tested. For QALY analyses, results from the EQ-5D-3L will be used together with costs associated with professional salaries, adherence, infrastructure, psychotropic medication and sick leaves. The effect of any potential confounding variable will be analyzed. Analyses will be conducted using SPSS v24.021 (IBM SPSS Statistics 21, 2017) by the IDIBELL biostatistics department.

Non-inferiority randomized trial testing two experimental conditions: 1) ehealth ecosystem, 2) usual psychosocial care. Assessment of main outcomes are conducted at recruitment (T0), 3 months from T0 (T1), 6 months from T0 (T2), and 9 months from T0 (T3). Hence, the design is 2 (treatment conditions) X 4 (assessments). The whole project's methodology adheres to the principles of Responsible Research and Innovation (RRI).

The sample size has been estimated with the support of the R software (R Core Team, 2020), setting a non-inferiority margin of 5 points in the Hospital Anxiety and Depression Scale (Vaganian et al., 2020), with power at 80% and one-tailed α of 2.5%. A dropout rate of 25% was assumed. It was anticipated that 152 participants were necessary (n = 76 per arm) to ensure that a two-sided 95% confidence interval would exclude the non-inferiority threshold.

Psychosocial eHealth in Advanced Lung Cancer

Stepped and Early Psychosocial Care in Advanced Lung Cancer Through E-health

Emotional distress will be assessed through the Hospital Anxiety and Depression Scale (HADS; Zigmond \& Snaith, 1983). The HADS measures symptoms of anxiety and depression and consists of 14 items: seven items for the anxiety subscale (HADS Anxiety) and seven for the depression subscale (HADS Depression). HADS Anxiety focuses mainly on symptoms of generalized anxiety disorder and HADS Depression is focused on anhedonia, the main symptom of depression. Each item is scored on a response scale with four alternatives ranging between 0 and 3. Higher scores means higher levels of depression and anxiety.

Spirituality will be assessed through the Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp; Peterman et al., 2002). This scale includes factors of meaning, peace and faith, assessed through 12 items rated on a 0-4 Likert scale. The overall score ranges between 0 and 48, and between 0 and 16 for each subscale, where higher scores are indicative of greater spiritual well-being.

Demoralization will be measured through the Demoralization Scale (DS-II; Kissane et al., 2004). The DS-II is a 3-point response, self-report scale comprising 16 items and 2 subscales: distress and coping ability, and meaning and purpose. Scores \<10 indicate no demoralization, between 10-19 moderate demoralization, and \>20 severe demoralization.

Health-Related Quality Of Life (HRQOL) will be assessed through the Functional Assessment of Cancer Therapy-Lung (FACT-L; Cella et al., 1995). The FACT-L is a 36-item, lung cancer-specific instrument that also includes the symptom-based Lung Cancer Sub-scale (LCS). It has 36 items organized into 5 subscales: 1) physical well-being, 2) functional well-being, 3) social/family well-being, 4) emotional well-being and 5) lung cancer. Responses are scored on a Likert-type scale ranging from 0 (not at all) to 4 (very much). Higher scores correspond to a better quality of life.

QoL will be measured through the European Quality of Life Scale (EQ-5D-3L; EQ-5D User Guides, 2021). The EQ-5D-3L consists of 2 pages: the EQ5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale of 100 points where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'.

Symptom management will be measured through the Edmonton Symptom Assessment System (ESAS-r; Carvajal et al., 2012). ESAS-r is an instrument that is commonly used both in PC and in advanced cancer situations. It has 10 visual numerical scales that assess physical and psychological symptoms. Patients choose the number that best represents the intensity of each symptom on a scale of 0 to 10.

Medication adherence will be measured through the Simplified Medication Adherence Questionnaire (ARMS-e; Kripalani et al., 2009). The ARMS-e assesses medication adherence in patients with chronic conditions in 12 self-reported items with 4 response possibilities: never, sometimes, most of the time and always. Lower overall scores correspond to better adherence.

Users' satisfaction with the platform will be measured through a 0-10 Visual Analogic Scale (VAS). Higher scores correspond to higher satisfaction.

Platform's usability will be asked to users through a 0-10 Visual Analogic Scale (VAS). Higher scores correspond to higher usability.

Emotional wellbeing will be measured through an emotional thermometer (ET; Harju et al., 2019) using a Visual Analogue Scale (VAS) (0-10). Higher scores correspond to higher well-being.

Asociación Española contra el Cáncer

Institut d'Investigació Biomèdica de Bellvitge

Institut Català d'Oncologia

Peer support

Diana Richter, PhD.

Hannah Brock

Anja Mehnert, PhD

Sarah Dwinger

Corinna Bergelt, Prof.

The present bicentric study has the aim to investigate the effectiveness of the peer supported mentoring program 'Peer2Me' with regard to psychosocial parameters using a prospective Comprehensive Cohort Design. Over a period of three months, acutely ill patients in the intervention group are accompanied by a mentor with the same disease and of similar age. Patients in the control group receive a one-time consultation. Before and after the intervention, mentors and mentees are interviewed about their psychosocial distress and quality of life.

After successful piloting of the mentoring program "Peer2Me", the mentoring program developed by us is now to be implemented and evaluated in a large-scale study in a second step, in order to be able to derive clinically relevant results.

A total of 190 acutely ill adolescent and young cancer patients (AYA) between the ages of 18 and 39 will be included in the study (intervention and control group). Again, young former cancer patients who have completed treatment will act as mentors and accompany acutely ill AYAs in the period after diagnosis for a period of three months. Prior to their assignment, the mentors take part in a training course, which includes the teaching of suitable conversation techniques, core topics in dealing with the cancer and advice on further care structures. Patients in the control group receive 30 minutes of standardized counseling regarding psychosocial care needs, including appropriate informational materials, during AYA consultation hours at both clinic sites. The study includes three measurement time points: t1: before the intervention; t2: after the end of the intervention; t3: 3 months after the end of the intervention. At all time points, participants will be surveyed using standardized questionnaires. With the help of these data and a comprehensive statistical analysis, the investigators want to make valid statements regarding the effects of peer mentoring on changes in psychological well-being as well as on social support and coping with illness.

Comprehensive cohort studies (CCS) are characterized by incorporating patient preferences into the study by using a "parallel preference group." The procedure is to ask patients' preferences at the beginning of the study before randomization. Those who do not consent to randomization will be retained in the study, but group assignment will be made according to their preferences. Patients who agree to randomization are randomized to one of the two groups (intervention vs. control).

Peer2Me: A Peer Supported Program for Adolescent and Young Adult Cancer Patients

Evaluation of a Peer Supported Program for Adolescent and Young Adult Cancer Patients

The Posttraumatic Growth Inventory (PTGI) measures the extent to which patients have experienced positive changes regarding cancer. The questionnaire contains 21 items in the five dimensions: new opportunities, relationship with others, personal strength, appreciation of life, and spiritual change. Using a three-point Likert scale, patients indicate the extent to which the item responses apply. Item scores are summed to form a total score, with higher scores indicating higher posttraumatic growth.

The Saarbrücken Personality Questionnaire on Empathy is the German adaptation of the Interpersonal Reactivity Index. The SPF is a questionnaire for self-assessment of one's own empathic abilities and consists of 16 items that measure both the cognitive and the emotional dimension of empathy on four subscales: imagination, empathic distress, empathic sympathy, and perspective taking.

A five-point Likert scale (1- never to 5- always) is used to assess the extent to which the statements are true.

The FLZ-M is a valid instrument that measures the subjective assessment of satisfaction in various areas of life. Life satisfaction is assessed using the two modules "general life satisfaction" and "satisfaction with health", each with eight items and one overall item. Subjective satisfaction and importance are assessed on a five-point Likert scale (0 = "dissatisfied" to 4 = "very satisfied").

The General Self-Efficacy Expectancy Scale is a self-assessment procedure with 10 items for assessing general optimistic self-convictions. It measures the expectation of subjective competence to cope with difficult situations such as cancer.

A four-point Likert scale is used to ascertain the extent to which patients agree with the statements. The individual test score is calculated by summing up all ten items.

Self-efficacy in coping with cancer can be defined as the confidence of a cancer patient in his or her ability to develop adaptive coping behavior. The German version of the short form of the Cancer Behavior Inventory (CBI-B-D) uses 14 items to describe coping behavior in the context of cancer. Patients estimate on a nine-point Likert scale how confident they are in performing certain behaviors. By summing all 14 item scores, a sum score is obtained, with high scores indicating high confidence in the ability to perform the coping behavior.

The Generalized Anxiety Scale measures symptoms of generalized anxiety disorders and the symptom severity of generalized anxiety on a four-point Likert scale using seven items. The individual item scores are summed to a total score, which can assume values between 0 and 21 points.

The Patient Health Questionnaire measures depressive symptoms on a four-point Likert scale using nine items. The PHQ-9 can be evaluated both categorically and by summing up the item characteristics. The scale sum value can reach values between 1 and 27.

The Berlin Social Support Scales measure six dimensions of social support in a multidimensional approach: perceived social support, received social support, provided social support, need and search for social support, and protective cushioning in the sense of protecting others from stress.

The HLS-EU-Q16 measures health literacy with 16 items and was developed from the long version of the HLS-EU-Q47. The items refer to various tasks and activities related to health care, disease prevention or health promotion. Respondents rate in each case how easy they think the corresponding task or activity is ("very easy," "fairly easy," "fairly difficult," "very difficult"). A sum score from 0 to 16 can be calculated, and the latter can be classified as insufficient (\<9), problematic (9-12), and sufficient (13-16) health literacy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
E-intervention on Subclinical Fear of Cancer Recurrence	NCT06207006	Cancer Psychooncology Fear of Cancer ...	eConquerFear-HK Basic Cancer Ca...	18 Years -	The University of Hong Kong
Psychological Factors and Oncological Outcomes of Triple-negative Breast Cancer	NCT04669522	Triple Negative...		18 Years -	Pius-Hospital Oldenburg
The Effect of Metacognition-based, Manualized Intervention on Fear of Cancer Recurrence	NCT04568226	Fear of Cancer ...	ConquerFear Int... Active control:...	18 Years -	The University of Hong Kong
The Effect of a Stepped-care Metacognition-based Intervention on Managing Fear of Cancer Recurrence	NCT06181331	Cancer Fear of Cancer ...	eConquerFear eHealthMaintena... ConquerFear eConquerFear+eH...	18 Years -	The University of Hong Kong
Managing Fear of Cancer Progression Metacognition-based Vs Supportive-expressive Based Approaches	NCT05679518	Advanced or Met... Fear of Cancer ... Metacognition-b... Supportive-expr... Psychooncology	ConquerFear int... CALM interventi... Basic Cancer Ca...	18 Years -	The University of Hong Kong
Internet-delivered Psycho-oncological Support	NCT02670200	Cancer	cognitive behav...	18 Years -	Neuropsychiatrischen Zentrums Hamburg-Altona
Psychosocial eHealth in Advanced Lung Cancer	NCT05497973	Lung Cancer, No... Lung Cancer Non... Lung Cancer Non... Lung Cancer Sta... Lung Cancer	E-health ecosys... Usual psychosoc...	18 Years - 80 Years	Institut Català d'Oncologia
Peer2Me: A Peer Supported Program for Adolescent and Young Adult Cancer Patients	NCT05336318	Cancer Psychosocial Pr...	Peer support	18 Years - 39 Years	University of Leipzig
E-intervention on Subclinical Fear of Cancer Recurrence	NCT06207006	Cancer Psychooncology Fear of Cancer ...	eConquerFear-HK Basic Cancer Ca...	18 Years -	The University of Hong Kong

Spots Global Cancer Trial Database for psychooncology