The Efficacy of a Brief Oncologist-delivered Intervention for Fear of Cancer Recurrence: A Cluster-randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The investigators will test a novel Clinician-led Intervention to address Fear of cancer Recurrence in cancer survivors (CIFeR), by 1) adapting the original Australian intervention manual to the Danish oncology context (CIFeR-DK), and 2) developing a brief e-learning program to train oncologists. The investigators will then 3) compare CIFeR-DK with an active control condition in a cluster-randomized controlled trial with 24 oncologists (the cluster unit) treating a minimum of 300 patients with breast, ovarian, lung and prostate cancer at Danish Oncology Departments at four hospitals in Aarhus, Vejle, Aalborg, and Copenhagen, and 4) explore fidelity, acceptability, feasibility, and perceived barriers and facilitators to use the intervention in routine follow-up care.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Aarhus University Hospital
RECRUITING
Aarhus
Contact Information
Primary
Eva Rames Nissen, PhD
enissen@oncology.au.dk
+4587162674
Backup
Louise Strøm, PhD
louisestroem@concology.au.dk
Time Frame
Start Date: 2024-06-14
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 300
Treatments
Experimental: Intervention (delivering CIFeR)
At the patient's first follow-up appointment after anti-cancer treatment, oncologists will, in addition to the usual follow-up procedure, deliver a brief psychological intervention (CIFeR)
No_intervention: Control (treatment as usual)
At the patients first follow-up appointment after anti-cancer treatment, oncologists will deliver treatment as usual (the usual follow-up procedure)
Related Therapeutic Areas
Sponsors
Leads: Aarhus University Hospital

This content was sourced from clinicaltrials.gov