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

NCT06554899 | Recruiting

• 1 other identifier: KB: R344-A19722
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Fear of cancer recurrence

  Assessed with the 9-item Fear of Cancer Recurrence Inventory Short Form (FCRI-SF), range 0-36. Higher scores indicate worse outcome

  T1 (2 weeks prior to intervention), T2 (one week post intervention), T3 (three months post intervention)

Secondary Outcomes (6)

• Anxiety and depression

  T1 (2 weeks prior to intervention), T2 (one week post intervention), T3 (three months post intervention)

• Patient reported intervention usefulness

  T1 (2 weeks prior to intervention), T2 (one week post intervention), T3 (three months post intervention)

• Metacognition

  T1 (2 weeks prior to intervention), T2 (one week post intervention), T3 (three months post intervention)

• Unmet needs

  T1 (2 weeks prior to intervention), T2 (one week post intervention), T3 (three months post intervention)

• Rumination

  T1 (2 weeks prior to intervention), T2 (one week post intervention), T3 (three months post intervention)

Other Outcomes (1)

• Self-efficacy (Oncologists)

  At Baseline, post-training (1-3 weeks post inclusion)(only oncologists in the intervention group), and after completed inclusion of patients (time frame depends on inclusion rate).

Study Arms (2)

Intervention (delivering CIFeR)

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)

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

Control (treatment as usual)

NO INTERVENTION

At the patients first follow-up appointment after anti-cancer treatment, oncologists will deliver treatment as usual (the usual follow-up procedure)

Interventions

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

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.

Intervention (delivering CIFeR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

Study Officials

• Robert Zachariae, Professsor

  Aarhus University and Aarhus University Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Rames Nissen, PhD

CONTACT

+4587162674; enissen@oncology.au.dk

Louise Strøm, PhD

CONTACT

louisestroem@concology.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: August 15, 2024
• Study Start: June 14, 2024
• Primary Completion: December 1, 2025
• Study Completion: June 1, 2026
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available upon request from time of publication and 5 year post publication
• Access Criteria: Written request to the primary investigator

Locations

DK (1)