It Is Time to Address Fear of Cancer Recurrence in the Family Caregiver: Adaptation, Feasibility, and Acceptability Study of an Online Version of the Fear Of Recurrence Therapy

Usability Study

6-8 female family caregivers will be recruited to conduct a usability study of this first version of FC-FORT. Participants will be recruited through the University of Ottawa, the Princess Margaret Cancer Centre, community partners and social media. Two therapists with extensive experience with online support groups to conduct the sessions will be recruited to conduct the groups. Therapist competency to administer FC-FORT will be determined by registered professionals in counselling or psychotherapy, at least 5 years of experience in psychosocial oncology, and having led at least one group. These therapists will receive an online training from the principal investigators before starting the usability study. Interested family caregivers will contact the research coordinator, via telephone or email, to be screened for eligibility and to complete the consent forms. All eligible participants will attend a one-on-one pre-therapy meeting to prepare them for the group work (i.e.: review expectations and assess whether group work is appropriate for the participant) and complete the 7-week FC-FORT intervention. Before starting the intervention, participants will receive a standardized manual describing each session's activities and assignments. After each of the seven sessions, the therapists and the participants will be asked to complete a short session feedback questionnaire, via Qualtrics, to assess the usefulness, usability, desirability, value, accessibility, and credibility of the session, as well as about participants' impressions of the online format and features, and the general readiness of the session for end users. Brief videoconference or telephone exit interviews will be conducted post-intervention with both the participating family caregivers and the therapists. The content of these interviews and questionnaires will be summarized and present it back to the project's advisory board in order to further refine the FC-FORT content and format.

Pilot Study

36 family caregivers will be recruited to participate in the study. Additionally, 3 therapists with extensive online support group experience to conduct the FC-FORT videoconference therapy sessions. Therapist competency to administer FC-FORT will be determined by registered professionals in counselling or psychotherapy, at least 5 years of experience in psychosocial oncology, and having led at least one group. Interested family caregivers will contact the research coordinator, via telephone or email, to be screened for eligibility and to complete the consent forms. This pilot study will serve as a first step in potential sample size calculations and recruitment times. For this pilot study, active recruitment will last for a period of 15 months during which 36 FC are aimed to be recruited in order to create 4 groups of 9 participants (2 intervention conditions and 2 WLCG). Feasibility of recruitement for the larger RCT will be determined using these critera: 1) If during our recruitment period less than 18 participants, recruitement for a larger RCT, using our current recruitment strategies, will be deemed not feasible, 2) If between 18 and 25 participants are recruited, then a larger multicentre approach for recruitment will be considered, 3) If recruit 25 participants or more, recruitement for a larger RCT, using our current methods, will be deemed feasible. The sample size will be reevaluated for the larger RCT based on the results from this pilot study.

FC-FORT consists of 7 consecutive weekly group sessions of 90-120 minutes each offered through videoconference and weekly assigned homework. FC-FORT is therapist led, however participants will receive a workbook where they can follow along, take notes, and complete the exercises and the homework assignments. The overall aim of FC-FORT is to guide FC towards a more manageable level of worry and fear of recurrence. The key goals are to: 1) distinguish worrisome symptoms from benign ones; 2) identify FCR triggers and inappropriate coping strategies; 3) facilitate the learning and use of new coping strategies, such as relaxation techniques, cognitive restructuring, communication strategies and the use of self-care; 4) increase tolerance for uncertainty; 5) promote emotional expression of specific fears that underlie FCR; and 6) re-examine life priorities and set realistic goals for the future. Each session is composed of exercices where participants have to answer questions, share with the group or watch videos. Furthermore, homework is assigned after each session to be completed before next week's session. Eligible participants will attend a one-on-one pre-therapy meeting with a study therapist to prepare them for the group work (i.e.: review expectations and assess whether group work is appropriate for the participant) and complete the 7-week FC-FORT intervention. Membership will be closed once groups are formed and the sessions have started to enhance group cohesiveness and consistency. Before starting the intervention, participants will receive a standardized manual describing each session's activities and assignments. All participants (including those in the wait list control group) will complete a questionnaire package pre intervention, post intervention, and at a three month follow up via Qualtrics. Additionally, participants will be asked to complete post session measures, namely the Working Alliance Inventory - Revised Short Form as well as the Group Cohesiveness Scale after the 1st, 4th and 7th sessions.