A clinician-led program to help cancer survivors cope with fear of recurrence
The Efficacy of a Brief Oncologist-delivered Intervention for Fear of Cancer Recurrence: A Cluster-randomized Controlled Trial
This study is testing a new program to help cancer survivors who are worried about their cancer coming back, by training doctors to better support them.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aarhus University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Aarhus) |
| Trial ID | NCT06554899 on ClinicalTrials.gov |
What this trial studies
This intervention focuses on addressing the fear of cancer recurrence among survivors of breast, ovarian, lung, and prostate cancer. The study adapts an existing Australian intervention for the Danish context and includes training for oncologists through an e-learning program. It employs a cluster-randomized controlled trial design involving 24 oncologists and aims to assess the intervention's fidelity, acceptability, feasibility, and barriers to implementation in routine care. Patients who have recently completed their primary cancer treatment and exhibit significant fear of recurrence will be invited to participate.
Who should consider this trial
Good fit: Ideal candidates are adult cancer survivors who have completed their primary treatment for breast, ovarian, lung, or prostate cancer and score 13 or higher on the Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF).
Not a fit: Patients who have not completed their primary cancer treatment or do not exhibit significant fear of recurrence may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce anxiety and improve the quality of life for cancer survivors dealing with fear of recurrence.
How similar studies have performed: Previous studies have shown promise in addressing fear of cancer recurrence through clinician-led interventions, indicating potential for success in this adapted approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Are ≥ 18 years old * Have completed their primary treatment, i.e., surgery, adjuvant chemotherapy, and/or radiotherapy, for breast, ovarian, prostate, or lung cancer at the participating departments between three weeks and three months previously. * Score \>= 13 on the FCRI-SF Exclusion Criteria: \-
Where this trial is running
Aarhus
- Aarhus University Hospital — Aarhus, Denmark (Recruiting)
Study contacts
- Principal investigator: Robert Zachariae, Professsor — Aarhus University and Aarhus University Hospital, Denmark
- Study coordinator: Eva Rames Nissen, PhD
- Email: enissen@oncology.au.dk
- Phone: +4587162674
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.