Recruiting

Oncologist Intervention for Fear of Cancer Recurrence in Breast, Ovarian, and Prostate Cancer

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What is being tested

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

Other
Who is being recruted

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: June 2024
See protocol details

Summary

Principal SponsorAarhus University Hospital
Study ContactEva Rames Nissen, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 14, 2024

Actual date on which the first participant was enrolled.

This study aims to help people who have been treated for breast, ovarian, or prostate cancer and are experiencing a fear of their cancer coming back, known as Fear of Cancer Recurrence (FCR). The study involves oncologists from several hospitals who will receive special training to provide their patients with a brief intervention designed to address FCR. This is important because fear of cancer coming back can significantly affect a person's quality of life and mental health. By teaching oncologists how to better support their patients' emotional needs, this study hopes to improve the mental well-being of cancer survivors. Participants in the study are cancer patients who have completed their primary treatment within the last three months and express a significant fear of recurrence. They will complete several questionnaires before and after their consultation with an oncologist to measure changes in their fear levels, anxiety, depression, and overall quality of life. The oncologists will deliver a structured intervention during the consultation, which includes providing reassurance, information on recurrence risk, and strategies to manage worry. The effectiveness of this intervention is assessed by comparing the patient's fear levels before and after the intervention, and the oncologists' experiences and confidence in delivering the intervention are also evaluated.

Official TitleThe Efficacy of a Brief Oncologist-delivered Intervention for Fear of Cancer Recurrence: A Cluster-randomized Controlled Trial
NCT06554899
Principal SponsorAarhus University Hospital
Study ContactEva Rames Nissen, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

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: \-

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Aarhus University Hospital

Aarhus, DenmarkOpen Aarhus University Hospital in Google Maps
Recruiting
One Study Center
Oncologist Intervention for Fear of Cancer Recurrence in Breast, Ovarian, and Prostate Cancer | PatLynk