CIFeR - A Clinician-led Intervention to Address Fear of Cancer Recurrence
ConditionFear of Cancer Recurrence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAarhus University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Clinician-led intervention to address fear of cancer recurrence (CIFeR)
Other interventionThe 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.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Intervention (delivering CIFeR)Experimental treatment 1 intervention
Group B: Control (treatment as usual)No intervention 0 interventions
Trial outcomes
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
Time frame
T1 (2 weeks prior to intervention), T2 (one week post intervention), T3 (three months post intervention)Secondary outcomes
1
Anxiety and depression
Assessed with the The Hospital Anxiety and Depression Scale (HADS), range 0-21. Higher scores indicate worse outcome
Time frame
T1 (2 weeks prior to intervention), T2 (one week post intervention), T3 (three months post intervention)2
Patient reported intervention usefulness
Assessed with the Patient Centered Communication Scale (PCC), range 7-28. Lower scores indicate worse outcome.
Time frame
T1 (2 weeks prior to intervention), T2 (one week post intervention), T3 (three months post intervention)3
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.
Time frame
T1 (2 weeks prior to intervention), T2 (one week post intervention), T3 (three months post intervention)4
Unmet needs
Assessed with Subscale of the Survivors Unmet Need Survey (SUNS-8), range 0-32. Higher scores indicate worse outcome.
Time frame
T1 (2 weeks prior to intervention), T2 (one week post intervention), T3 (three months post intervention)Other outcomes
1
Self-efficacy (Oncologists)
27-item Self-efficacy in Patient-Centeredness Questionnaire (SEPCQ-27), range 0-108. Higher scores indicate better outcome.
Time frame
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).Sponsors and contacts
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Source ClinicalTrials.gov