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CIFeR - A Clinician-led Intervention to Address Fear of Cancer Recurrence

NCT06554899 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-08-21

No results posted yet for this study

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.

Conditions

  • Fear of Cancer Recurrence

Interventions

OTHER

Clinician-led intervention to address fear of cancer recurrence (CIFeR)

The intervention includes five components informed by theoretical models and existing interventions for FCR: 1) FCR normalization: reassurance that FCR is a common and normal phenomenon after treatment for cancer, 2) Providing prognostic information: asking patients whether they would like information about their risk of recurrence and, if yes,providing this information, 3) Providing education and take-home information on red-flag recurrence symptoms, 4) Brief advice on managing worry: distraction, meditation, mindfulness, reassurance, and links to online resources to manage FCR, and 5) referral to a psychologist if FCR is high (FCRI-SF \>= 22), or if deemed helpful by the patient or clinician. Access will be provided to ConquerFear-Group delivered online by trained psychologists.

Sponsors & Collaborators

  • Aarhus University Hospital

    lead OTHER

Principal Investigators

  • Robert Zachariae, Professsor · Aarhus University and Aarhus University Hospital, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-14
Primary Completion
2025-12-01
Completion
2026-06-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06554899 on ClinicalTrials.gov