Trial Title:
CIFeR - A Clinician-led Intervention to Address Fear of Cancer Recurrence
NCT ID:
NCT06554899
Condition:
Fear of Cancer Recurrence
Conditions: Official terms:
Recurrence
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Other
Intervention name:
Clinician-led intervention to address fear of cancer recurrence (CIFeR)
Description:
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.
Arm group label:
Intervention (delivering CIFeR)
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.
Detailed description:
STUDY DESIGN:
The study is designed as a parallel cluster-randomized controlled trial with oncologists
(cluster unit) treating breast, ovarian, and prostate cancer at the oncology departments
at Aarhus University Hospital (AUH), Vejle Hospital (VH), Aalborg University Hospital
(AAUH), and Copenhagen University Hospital (CUH), and randomized 1:1 to intervention
versus active control.
Participants:
All oncologists treating breast, ovarian, and prostate cancer at the participating
departments are eligible for the study and will be recruited by our collaborators at the
participating departments. Eligible patients score >= 13 on the FCRI-SF and have
completed their primary treatment i.e., surgery, adjuvant chemotherapy, and/or
radiotherapy, for breast, ovarian, lung and prostate cancer at the participating
departments between three weeks and three months previously.
Procedure:
Patients scheduled for a follow-up visit with the participating oncologists will receive
a secure e-mail invitation to participate in the study and a link to a RedCap
questionnaire. Patients willing to participate will provide their informed consent
electronically and complete the 9-item FCRI-SF. Patients scoring >= 13 are provided with
additional information about the study and asked for their consent to participate.
One week before the planned follow-up consultation, they will be asked to complete a
RedCap baseline questionnaire (T1). One week and three months after the consultation, the
patients will be asked to complete the RedCap post-intervention (T2) and follow-up
questionnaires (T3).
Oncologists will complete a RedCap baseline questionnaire assessing age, gender, years of
experience, and self-efficacy in managing patient FCR. Oncologists will then be allocated
to the intervention or active control arm using a stratified randomization sequence
generated by the Aarhus University clinical trial unit ensuring a balanced allocation of
oncologists according to the cancer type treated. Oncologists will then receive a link to
online CIFeR training and report their post-training self-efficacy for managing patient
FCR. During the consultation, the oncologist will deliver the CIFeR intervention and
complete a brief 5-item checklist on whether they delivered all five components and, if
not, why. After including all patients, the oncologist is asked to complete a follow-up
RedCap questionnaire on self-efficacy in managing patient FCR.
The CIFeR intervention:
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
psycho-oncologists.
Outcome measures:
Patients:
The primary outcome is the change in FCR, assessed with the 9-item Fear of Cancer
Recurrence Inventory Short Form (FCRI-SF). Secondary outcomes include a) anxiety and
depression assessed with the The Hospital Anxiety and Depression Scale (HADS), b) patient
reported intervention usefulness assessed with the Patient Centered Communication Scale
(PCC), c) metacognition assessed with the metacognitions questionnaire (MCQ-30), d) unmet
needs assessed with Subscale of the Survivors Unmet Need Survey (SUNS-8), e) rumination
assessed with the Penn State Worry Questionnaire (PSWQ), and f) General Quality of Life
(QoL) assessed with the EQ-5D for later use in cost-effectiveness analysis. All measures
will be completed at all three time-points (T1-T3).
At six months, the investigators will ask a subset of 15-20 patients to participate in a
semi-structured phone interview about their experience with the intervention.
Oncologists:
Oncologists complete a general item on self-efficacy in managing patient FCR together
with the 27-item Self-efficacy in Patient-Centeredness Questionnaire (SEPCQ-27) at
baseline, post-training (only oncologists in the intervention group), and after completed
inclusion. Based on a suggested framework for implementation outcomes, the investigators
will assess with 11-point scales: 1) acceptability, 2) appropriateness, 3) feasibility,
together with 4) fidelity, measured as the average number of components oncologists
report having delivered to patients, and 5) sustainability measured as the proportion of
oncologists in the intervention group who report having used CIFeR at least once within
the last three months, measured six months after completed inclusion. Six months after
the inclusion of their last patient, all oncologists will be asked to participate in a
semi-structured interview and provide feedback on the CIFeR-training and their
experiences with the intervention, including perceived utility and the perceived barriers
and facilitators to implementing CIFeR in routine care. The investigators will also
examine CIFeR e-training analytics regarding access and time spent on the various parts.
Criteria for eligibility:
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:
-
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Aarhus University Hospital
Address:
City:
Aarhus
Zip:
8200
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Birgitte Offersen, Professor
Phone:
+4578454933
Email:
birgitte.offersen@auh.rm.dk
Start date:
June 14, 2024
Completion date:
June 1, 2026
Lead sponsor:
Agency:
Aarhus University Hospital
Agency class:
Other
Source:
Aarhus University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06554899
