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

Neoplasm Metastasis

Disease Progression

Neoplastic Processes

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

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

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

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.

Danielle Wing Lam Ng, PhD

Karen Chan

Wendy Chan

Ava Kwong

Wendy Wing Tak Lam, PhD

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.

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.

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.

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
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
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 basic cancer care