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It's Time to Address Fear of Cancer Recurrence in Family Caregivers: Online Version of the Fear Of Recurrence Therapy

NCT05441384 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-05-10

No results posted yet for this study

Summary

Fear of cancer recurrence (FCR) is common, persistent, and is associated with negative outcomes. Studies show that family caregivers (FC) 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, including a group intervention called Fear of Recurrence Therapy (FORT). However, none have ever been adapted and offered to caregivers. The goals of the proposed study are to demonstrate 1) that a newly adapted intervention of FORT (FC-FORT) is feasible (i.e., participant recruitment, attendance and participation) and acceptable (i.e., FC satisfaction of the intervention) for a larger study, and 2) the clinical implications of FC- FORT on FCR and quality of life. An advisory board composed of researchers, therapists, and FC was created to adapt FORT for FC and to an online format. FC and therapists are currently being recruited to conduct a usability study of the newly adapted FC-FORT. They will be asked to complete a session feedback questionnaire after each session and to take part in an exit interview. The content of these will be summarized back to the advisory board in order to further refine FC-FORT. Following a successful usability study, FC-FORT will be given to four groups of nine new FC (pilot study). Participants will be recruited directly by clinicians and by outreach mailout efforts. They will complete a questionnaire package before and after the intervention, as well as at a three month follow up. The proposed study is needed to determine if an already developed FCR intervention can be adapted to family caregivers and if it can be successfully pilot tested. This will help bridge an important gap in bringing evidence-based care to caregivers who have never been offered help before for their FCR. The proposed project will also allow to further feasibility and acceptability of E-Health interventions.

Conditions

  • Cancer
  • Caregiver
  • CBT
  • Fear Cancer

Interventions

BEHAVIORAL

Family Caregiver - Fear Of Recurrence Therapy (FC-FORT)

7 weekly sessions of 90-120 minutes each. During the 7 weeks, participants will be asked to participate in activities, participate in group discussions, and complete homework assignments.

Sponsors & Collaborators

  • University of Ottawa

    lead OTHER

Principal Investigators

  • Sophie Lebel, PhD · University of Ottawa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2022-09-01
Completion
2024-03-01

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05441384 on ClinicalTrials.gov