It's Time to Address Fear of Cancer Recurrence in Family Caregivers: Adaptation, Feasibility, and Acceptability Study of an Online Version of the Fear of Recurrence Therapy (FORT)

Abstract

Fear of cancer recurrence (FCR), defined as the fear, worry, or concern that cancer may come back or progress, is the most common unmet need in cancer survivors. Family caregivers of cancer patients experience equal or greater levels of FCR than survivors themselves. Similarly to cancer survivors, FCR in family caregivers is persistent and associated with negative outcomes. While several interventions have demonstrated their ability to reduce FCR among cancer patients, few interventions have been developed and/or adapted to specifically address family caregiver's FCR. The overarching thesis objectives were: (a) to adapt a standardized and manualized cognitive-existential in-person group therapy intervention aimed at addressing FCR in cancer survivors to family caregivers and to an online format; (b) to conduct a usability study to assess the usefulness, usability, desirability, value, accessibility, credibility, online format and features, and the general readiness of this newly adapted intervention; and (c) to pilot-test the feasibility, acceptability, and clinical significance of the adapted intervention to inform a larger randomized control trial study.

In study 1, an advisory board composed of researchers (n=10), therapists (n=2), and family caregivers (n=4) was created to adapt the original intervention to family caregivers and an online format. The advisory board met on 7 occasions and reviewed the intervention manuals, session content, the questionnaire packages, and recruitment strategies. Major (e.g., virtual format, exercises in self-care and overcoming protective buffering, addition of a 7th session) and minor (e.g., modifying language, adding standalone explanations/examples) adaptations were made to the original intervention. Once adapted, women family caregivers (N=4) and therapists (N=3) were recruited to conduct a usability study. Family caregivers completed the intervention which was comprised of 7 virtual sessions of 90 minutes and included cognitive restructuring exercises, behavioural experiments, relaxation techniques, existential processing of the here-and-now, and finding meaning in life post-diagnosis. All participants completed feedback questionnaires after each session and took part in an exit interview (30-60 minutes). Overall, family caregivers and therapists expressed good levels of satisfaction with the intervention, but suggestions (e.g., increasing session length to 120 mins; reorganizing flow of sessions and use of breakout rooms) were made to further improve the intervention's content and format. Results were summarized back to the advisory board and a second round of usability testing was deemed necessary. In the second round, new women family caregivers (N=6) and the same therapists completed the adapted intervention. Both family caregivers and therapists expressed high satisfaction with the intervention's usability and the advisory board deemed it ready for pilot testing.

In study 2, the intervention's feasibility, acceptability and clinical significance were further pilot tested using a mixed-method, parallel, two-group (intervention and waitlist control) randomized control trial. Twelve family caregivers (n = 7 intervention; n = 5 control) completed the 7 weekly sessions (120 minutes) of online group therapy and questionnaire packages at pre- (T0) and post (T1), and 3-month follow up (T2). Those in the intervention group also completed exit interviews (30-60 mins). Feasibility and acceptability criteria were partially met. Analyses did not reveal any significant differences on the secondary outcomes between groups or across time. Qualitative analyses revealed high importance, helpfulness, satisfaction, and group cohesion. Suggestions were made to improve the intervention (e.g., grouping caregivers by caregiving experiences, reducing content or increasing number of sessions).

This study is the first to offer an intervention solely dedicated to family caregivers living with FCR. While it demonstrates promising results in addressing FCR in family caregivers, significant issues with the pilot's feasibility (e.g., recruitment, randomization) and acceptability (e.g., dropout, session completion) were discovered. Future research should focus on addressing these issues and efforts should be put into conducting a second pilot study before the intervention's effectiveness can be evaluated in a larger scale randomized control trial.