Actively Recruiting
The Efficacy of a Brief Oncologist-delivered Intervention for Fear of Cancer Recurrence in Breast, Ovarian, Lung, and Prostate Cancer: A Cluster-randomized Controlled Trial
Led by Aarhus University Hospital · Updated on 2024-08-21
300
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new Clinician-led Intervention called CIFeR to address Fear of Cancer Recurrence (FCR) in survivors of breast, ovarian, lung, and prostate cancer. This trial will adapt the Australian CIFeR program to the Danish oncology setting and develop an e-learning program to train oncologists. The study aims to compare CIFeR with usual follow-up care and explore how well the intervention is accepted, feasible, and used in routine care. The trial is a cluster-randomized controlled study with oncologists as the unit of randomization. Oncologists treating eligible cancer patients are assigned either to deliver the CIFeR intervention or to continue usual care. The CIFeR intervention includes five key parts: normalizing FCR, offering prognostic information, educating on warning symptoms, advising on worry management techniques, and referring to psychologists if needed. Patients receive the intervention during their first follow-up visit after completing their primary cancer treatment. Participants will complete questionnaires before the intervention, one week after, and three months later to assess changes in FCR and related outcomes like anxiety, depression, and quality of life. Oncologists will complete surveys about their confidence in managing FCR and feedback on the intervention. A subset of patients and oncologists will also take part in interviews to share their experience. The study will monitor the delivery and sustainability of CIFeR over time, with total participation lasting at least three months post-intervention.
CONDITIONS
Brief Title
CIFeR - A Clinician-led Intervention to Address Fear of Cancer Recurrence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Are 18 years old or older
- Have completed primary treatment (surgery, adjuvant chemotherapy, and/or radiotherapy) for breast, ovarian, prostate, or lung cancer between three weeks and three months ago
- Score 13 or higher on the Fear of Cancer Recurrence Inventory Short Form (FCRI-SF)
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for follow-up consultation where eligibility is assessed
Duration - Single consultation visit
Participants receive either the clinician-led CIFeR intervention addressing fear of cancer recurrence or treatment as usual during their first follow-up appointment after primary cancer treatment.
1 visit (in-person) for intervention or treatment as usual at the follow-up appointment
Duration - Approximately 3 months
Participants complete questionnaires to assess fear of cancer recurrence and related outcomes before and after the intervention over a three-month period.
3 remote questionnaire completions: baseline 2 weeks before intervention, 1 week post intervention, and 3 months post intervention
Trial Site Locations
Total: 1 location
1
Aarhus University Hospital
Aarhus, Denmark, 8200
Actively Recruiting
Research Team
E
Eva Rames Nissen, PhD
L
Louise Strøm, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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