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Pilot and feasibility studies
Nov 19, 2024;10 (1): 143.

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).

Jani Lamarche, Rinat Nissim, Jonathan Avery, Jiahui Wong, Christine Maheu, Sylvie D Lambert, Andrea M Laizner, Jennifer Jones, Mary Jane Esplen, Sophie Lebel
Author Information
  1. Jani Lamarche: School of Psychology, University of Ottawa, 136 Jean-Jacques-Lussier Private, Ottawa, ON, K1N 9A8, Canada. jlama023@uottawa.ca. ORCID
  2. Rinat Nissim: Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
  3. Jonathan Avery: Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
  4. Jiahui Wong: Cancer Chat De Souza Institute, 222 St Patrick Street, Office 503, Toronto, ON, M5T 1V4, Canada.
  5. Christine Maheu: Ingram School of Nursing, McGill University, 680 Sherbrooke West, Suite 1800, Montreal, QC, H3A 2M7, Canada.
  6. Sylvie D Lambert: Ingram School of Nursing, McGill University, 680 Sherbrooke West, Suite 1800, Montreal, QC, H3A 2M7, Canada.
  7. Andrea M Laizner: Ingram School of Nursing, McGill University, 680 Sherbrooke West, Suite 1800, Montreal, QC, H3A 2M7, Canada.
  8. Jennifer Jones: Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
  9. Mary Jane Esplen: Department of Psychiatry, Temerty Faculty of Medicine, University of Toronto, 250 College Street, Toronto, Canada.
  10. Sophie Lebel: School of Psychology, University of Ottawa, 136 Jean-Jacques-Lussier Private, Ottawa, ON, K1N 9A8, Canada.
PMID: 39563465 DOI: 10.1186/s40814-024-01567-4

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.

Keywords

Acceptability Cancer Caregivers Fear of cancer recurrence Feasibility Pilot study

Associated Data

ClinicalTrials.gov | NCT05441384

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