Managing fear of cancer recurrence in survivors through a stepped-care intervention
The Effect of a Stepped-care Metacognition-based Intervention on Managing Fear of Cancer Recurrence: Sequential, Multiple Assignment, Randomized Controlled Trial (SMARTs)
This study is testing a new way to help cancer survivors manage their fear of cancer coming back by trying different support methods based on how they respond.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 1 site (Hong kong) |
| Trial ID | NCT06181331 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of a stepped-care metacognition-based intervention designed to help cancer survivors manage their fear of cancer recurrence (FCR). Using a sequential multiple-assignment randomized controlled trial (SMART) design, participants will receive different interventions based on their responses, starting with eConquerFear or eHealthMaintenance. The study aims to determine the best initial intervention and the most effective subsequent strategies for those who do not respond initially. The focus is on reducing FCR through adaptive interventions that address maladaptive metacognition and cognitive attentional syndrome.
Who should consider this trial
Good fit: Ideal candidates are Cantonese- or Mandarin-speaking Chinese patients diagnosed with curable breast, colorectal, or gynecological cancer who completed treatment within the last five years and exhibit subclinical levels of fear of cancer recurrence.
Not a fit: Patients with metastatic cancer, current depression or psychosis, or those already receiving psychological treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce fear of cancer recurrence in survivors, improving their quality of life.
How similar studies have performed: While there is ongoing research in psychooncology, this specific stepped-care approach is relatively novel and has not been extensively tested in similar contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Cantonese- or Mandarin-speaking Chinese patients diagnosed with curable breast, colorectal, or gynecological cancer, who had completed treatment (except endocrine therapy) within five years, and with a Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF) score of 13 to 21 indicating subclinical FCR will be included. Exclusion Criteria: * Patients with metastatic cancer, with a current diagnosis of depression or psychosis, or who are already receiving psychological treatment will be excluded.
Where this trial is running
Hong kong
- QMh department of surgery — Hong kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Wendy Lam, PhD — School of Public Health, The University of Hong Kong
- Study coordinator: Danielle Ng, PhD
- Email: dwlng@hku.hk
- Phone: +852 39179897
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.