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| Name | Class |
|---|---|
| Health and Medical Research Fund | OTHER_GOV |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eConquerFear-HK | Experimental | 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. |
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| Basic Cancer Care | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eConquerFear-HK | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of subject recruitment | number of participants consent and being randomized/number of eligible patients x 100 | baseline |
| Rate of subject retention | number of participants who complete follow-up assessments at 3 and 6 months post-baseline/number of participants enrolled x 100 | baseline,3-months post-intervention and 6-months post-intervention |
| Adherence rate to intervention | number of participants who complete the intervention/number of being allocated to attend the intervention x 100 | the immediate post-intervention |
| Intervention utility | Intervention utility will be assessed using the site use metrics, including total number of log-ins | the immediate post-intervention |
| Acceptability of the 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. | the immediate post-intervention |
| Change of fear of cancer recurrence | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of quality of life | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Danielle Ng, PhD | Contact | 39179897 | dwlng@hku.hk |
| Name | Affiliation | Role |
|---|---|---|
| Danielle Ng, PhD | School of Public Health, The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary Hospital-Department of Surgery | Recruiting | Hong Kong | Hong Kong |
All IPD that underlie results in a publication will be available from the PI upon reasonable request.
starting 6 months after publication
Information will be available from the PI upon reasonable request. The author to review requests is the PI.
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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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.
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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).
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| Basic Cancer Care | Behavioral | 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. |
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| Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention |
| Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention |
| Change of general psychological distress | 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. | Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention |
| Attitude towards internet assessed using categorical Likert scales | 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. | the immediate post-intervention |
| Treatment satisfaction | 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. | the immediate post-intervention |
| Change of metacognition | 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 | Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention |