Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06554899

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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)
Not Eligible

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

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Your Study Journey

Screening

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

Treatment

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

Follow-up

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

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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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