E-intervention on Subclinical Fear of Cancer Recurrence
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: eConquerFear-HK, Basic Cancer Care.
- Who it may be relevant to
- Registry conditions: Cancer, Psychooncology, Fear of Cancer Recurrence. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Behavioral eConquerFear-HK
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. - Behavioral Basic Cancer Care
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.
Primary outcome measures
- Rate of subject recruitment [Time frame: baseline]
- Rate of subject retention [Time frame: baseline,3-months post-intervention and 6-months post-intervention]
- Adherence rate to intervention [Time frame: the immediate post-intervention]
- Intervention utility [Time frame: the immediate post-intervention]
- Acceptability of the intervention [Time frame: the immediate post-intervention]
- Change of fear of cancer recurrence [Time frame: Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention]
Secondary outcome measures (5)
- Change of quality of life [Time frame: Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention]
- Change of general psychological distress [Time frame: Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention]
- Attitude towards internet assessed using categorical Likert scales [Time frame: the immediate post-intervention]
- Treatment satisfaction [Time frame: the immediate post-intervention]
- Change of metacognition [Time frame: Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Hong Kong · 1 center
- Queen Mary Hospital-Department of Surgery — Hong Kong
Identifiers
NCT: NCT06207006 · UW22-602