E-intervention on Subclinical Fear of Cancer Recurrence
- Conditions
- PsychooncologyFear of Cancer RecurrenceCancer
- Interventions
- Behavioral: eConquerFear-HKBehavioral: Basic Cancer Care
- Registration Number
- NCT06207006
- Lead Sponsor
- The University of Hong Kong
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 48
- Cantonese- or Mandarin-speaking Chinese cancer survivors
- recently diagnosed with potentially curable (stage 0 to III) colorectal or breast cancer
- had recently completed surgery as primary treatment
- have completed hospital-based adjuvant treatments (including radiotherapy and chemotherapy) within the past six months
- scored 13 to 21 on the fear of cancer recurrence-short form will be recruited.
- non-Chinese ethnicity
- metastatic cancer
- with current diagnosis of depression or psychosis or are currently receiving psychological treatments
- language or intellectual difficulties that prevent them from understanding the intervention content
- having limited or no Internet access.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description eConquerFear-HK eConquerFear-HK 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. Basic Cancer Care Basic Cancer Care 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.
- Primary Outcome Measures
Name Time Method Change of fear of cancer recurrence Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention 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.
Rate of subject recruitment baseline number of participants consent and being randomized/number of eligible patients x 100
Adherence rate to intervention the immediate post-intervention number of participants who complete the intervention/number of being allocated to attend the intervention x 100
Acceptability of the intervention the immediate post-intervention 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.
Rate of subject retention baseline,3-months post-intervention and 6-months post-intervention number of participants who complete follow-up assessments at 3 and 6 months post-baseline/number of participants enrolled x 100
Intervention utility the immediate post-intervention Intervention utility will be assessed using the site use metrics, including total number of log-ins
- Secondary Outcome Measures
Name Time Method Attitude towards internet assessed using categorical Likert scales the immediate post-intervention 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.
Change of quality of life Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention 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).
Change of general psychological distress Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention 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.
Change of metacognition Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention 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
Treatment satisfaction the immediate post-intervention 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.
Trial Locations
- Locations (1)
Queen Mary Hospital-Department of Surgery
ðŸ‡ðŸ‡°Hong Kong, Hong Kong