1. 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).
- Author
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Lamarche J, Nissim R, Avery J, Wong J, Maheu C, Lambert SD, Laizner AM, Jones J, Esplen MJ, and Lebel S
- 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., Competing Interests: Declarations Ethics approval and consent to participate Ethical approval was granted from the University of Ottawa Ethics Committee (Reference Number H-05–20-5584), The Ottawa Hospital Research Institute’s Ottawa Health Science Network Research Ethics Board (Reference Number 20230147-01H) and The University Health Network’s Research Ethics Board (Reference Number 21–5060.3). All participants will provide informed consent by acknowledging that they have read and understood the Consent Form before beginning the group intervention. Any amendments to the study protocol will be communicated to the University’s Ethics Committee for formal approval. Consent for publication Not applicable. Competing interests The authors declare no competing interests., (© 2024. The Author(s).)
- Published
- 2024
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