Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Recurrence

Disease Attributes

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

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

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

The University of Hong Kong

Associate Professor

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

Basic Cancer Care

Danielle Wing Lam Ng, PhD

Karen Chan

Wendy Chan

Dominic Foo

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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
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

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