CIFeR - A Clinician-led Intervention to Address Fear of Cancer Recurrence
NCT Number: NCT06554899
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Fear of Cancer Recurrence
Interventions: OTHER: Clinician-led intervention to address fear of cancer recurrence (CIFeR)
Sponsor: Aarhus University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-06-14
Completion Date: 2026-06-01
Locations: Aarhus University Hospital, Aarhus, 8200, Denmark

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.

Primary Outcome Measures: 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 Outcome Measures: Anxiety and depression, Assessed with the The Hospital Anxiety and Depression Scale (HADS), range 0-21. Higher scores indicate worse outcome, T1 (2 weeks prior to intervention), T2 (one week post intervention), T3 (three months post intervention)|Patient reported intervention usefulness, Assessed with the Patient Centered Communication Scale (PCC), range 7-28. Lower scores indicate worse outcome., T1 (2 weeks prior to intervention), T2 (one week post intervention), T3 (three months post intervention)|Metacognition, Assessed with the metacognitions questionnaire (MCQ-30). The MCQ-30 assesses various aspects of metacognition, including subscales: cognitive confidence, positive beliefs, cognitive self-consciousness, uncontrollability and danger, and the need to control thoughts. Subscale scores range from 6 to 24. Higher scores indicate greater conviction in metacognitive beliefs., T1 (2 weeks prior to intervention), T2 (one week post intervention), T3 (three months post intervention)|Unmet needs, Assessed with Subscale of the Survivors Unmet Need Survey (SUNS-8), range 0-32. Higher scores indicate worse outcome., T1 (2 weeks prior to intervention), T2 (one week post intervention), T3 (three months post intervention)|Rumination, Assessed with the Penn State Worry Questionnaire (PSWQ), range 5-25. Higher scores indicate worse outcome., T1 (2 weeks prior to intervention), T2 (one week post intervention), T3 (three months post intervention)|General Quality of Life (QoL), Assessed with the EuroQol Group Association EQ-5D-L5, representing five domains (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) with each five severity levels. Higher levels indicate worse outcome., T1 (2 weeks prior to intervention), T2 (one week post intervention), T3 (three months post intervention)
Other Outcome Measures: Self-efficacy (Oncologists), 27-item Self-efficacy in Patient-Centeredness Questionnaire (SEPCQ-27), range 0-108. Higher scores indicate better outcome., 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).