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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
177
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.
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.
Queen Mary Hospital-Department of Surgery
Hong Kong, Hong Kong
Kwong Wah Hospital-Breast Center
Hong Kong, Hong Kong
Prince of Wales Hospital-Department of Surgery
Hong Kong, Hong Kong
Queen Mary Hospital-Department of Obstetrics & Gynaecology
Hong Kong, Hong Kong
Fear of cancer recurrence
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.
Time frame: Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention
Metacognitions
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.
Time frame: Baseline, immediate post-intervention, 3months post-intervention, and 6months
EORTC QLQ-C30
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.
Time frame: Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention
Self-efficacy
Self-efficacy for managing chronic disease will be assessed using the Self-Efficacy for Managing Chronic Disease 6-item Scale.
Time frame: Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention
Coping behavior
Coping behavior will be assessed using the 28-item Chinese Brief COPE.
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The University of Hong Kong Jockey Club Institute of Cancer Care
Hong Kong, Hong Kong
Tung Wah Hospital-Department of Surgery
Hong Kong, Hong Kong
Time frame: Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention
Experimental avoidance
Experimental avoidance will be assessed using the Acceptance and action questionnaire.
Time frame: Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention
Cognitive Attentional Syndrome
Cognitive Attentional Syndrome (CAS) will be assessed using the Cognitive-attentional Syndrome questionnaire (CAS-1).
Time frame: Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention
Intolerance of uncertainty
Intolerance of uncertainty (IU) will be assessed using the 12-item Intolerance of uncertainty-12.
Time frame: Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention
Psychological distress
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.
Time frame: Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention
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.
Time frame: Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention
Treatment expectancy
Treatment expectancy will be assessed using the 6-item credibility/ expectancy questionnaire.
Time frame: Baseline and immediate post-intervention
Therapeutic alliance
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
Time frame: Immediate post-intervention
Treatment satisfaction
Treatment satisfaction will be assessed using the evaluation form. Participants will be asked to indicate their overall satisfaction with the intervention they have received.
Time frame: Immediate post-intervention