It is time to address fear of cancer recurrence in family caregivers: protocol for the feasibility and acceptability of a randomized pilot study of the online version of the Family Caregiver–Fear Of Recurrence Therapy (FC-FORT)
Bibliographic record
Abstract
BACKGROUND: Fear of cancer recurrence (FCR) is common, persistent, and is associated with lower quality of life, impaired functioning, and psychological distress in cancer patients. Studies suggest that family caregivers of cancer patients experience equal or greater levels of FCR than patients themselves. In the past 5 years, several interventions have demonstrated their ability to reduce FCR among cancer patients and in patient-caregiver dyads. However, to date, no intervention exists to individually target family caregiver's FCR. The aims of the proposed pilot study are to (1) assess the feasibility and acceptability of the newly adapted Family Caregiver-Fear Of Recurrence Therapy (FC-FORT) intervention to inform a larger randomized control trial study, and (2) estimate the clinical significance of FC-FORT. Initial evaluation of FC-FORT revealed high user satisfaction and usability. METHODS: A parallel, two-group, pilot randomized controlled trial comparing FC-FORT to a waitlist control (care as usual) will be conducted. Participant inclusion criteria are (a) women family caregivers taking care of adult cancer patients (no recurrence), (b) experiencing clinical levels of FCR, (c) access to a computer/internet connection, and (d) living in Canada. Participants (n = 36) will be recruited at Ottawa and Toronto hospitals, previous study participant pools, through social media and community partners across Canada. Participants in the intervention group will complete the FC-FORT intervention (7 consecutive weeks of virtual group therapy and homework). Participants in the control group will be offered the intervention after their participation in the study. All participants will be asked to complete questionnaire packages at baseline (T0), immediately post-intervention (7 weeks; T1) and at 3-months post-intervention (T2). Feasibility (e.g., recruitment, allocation, fidelity), acceptability (e.g., dropout, completion, satisfaction) and clinical significance of secondary outcomes will be evaluated (i.e., FCR illness uncertainty). Participants in the intervention group will be asked to complete measures of group cohesion and therapeutic alliance and take part in a semi-structured exit interview exploring their overall experience with FC-FORT. DISCUSSION: This project will evaluate the acceptability and feasibility of the newly adapted FC-FORT to inform a larger trial. TRIAL REGISTRATION: NCT, NCT05441384. Registered July 1st, 2022, https://classic. CLINICALTRIALS: gov/ct2/show/NCT05441384.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".