Clinical trial · Interventional
It's Time to Address Fear of Cancer Recurrence in Family Caregivers: Online Version of the Fear Of Recurrence Therapy
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Caregiver | — | UNRESOLVED | — |
| CBT | — | UNRESOLVED | — |
| Fear Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Family Caregiver - Fear Of Recurrence Therapy (FC-FORT) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CBT/Existential Group Therapy for Fear of Cancer Recurrence
- description
- Participants will receive 7 weekly group therapy sessions consisting of psychoeducation on fear of cancer recurrence, relaxation training, CBT, and evidenced-based tips to decrease avoidance and anxiety surrounding fear of cancer recurrence.
- interventionNames
- Behavioral: Family Caregiver - Fear Of Recurrence Therapy (FC-FORT)
- type
- NO_INTERVENTION
- label
- Wait-list Control Group
- description
- Participants assigned to this arm wait about 3-months to receive the intervention.
Primary outcomes (2)
- measure
- Changes in baseline fear of cancer recurrence after intervention
- timeFrame
- Changes in baseline fear of cancer recurrence 7 weeks after the start of the intervention
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female adult FC caring for an adult cancer survivor of any type of cancer type, stages I-III, who has completed treatments and has not had a recurrence of their cancer; * A score of 13 or greater on the Fear of Cancer Recurrence Inventory-Short Form (range 0-36), suggesting clinical levels of FCR; * Access to a computer and stable internet connection; * Living in Canada. Exclusion Criteria: * Individuals who do not identify as female; * Family caregiver of a pediatric cancer survivor; * Non-English speaking; * Currently participating in another therapist-led psychosocial support group or a peer-led support group; * Individuals with unmanaged/undermanaged mental health disorder judged to be clinically contra-indicated and/or likely to affect the group work.
References
Publications (6)
- BACKGROUNDMaheu C, Lebel S, Courbasson C, Lefebvre M, Singh M, Bernstein LJ, Muraca L, Benea A, Jolicoeur L, Harris C, Ramanakumar AV, Ferguson S, Sidani S. Protocol of a randomized controlled trial of the fear of recurrence therapy (FORT) intervention for women with breast or gynecological cancer. BMC Cancer. 2016 Apr 25;16:291. doi: 10.1186/s12885-016-2326-x. PMID 27112319
- BACKGROUNDMoran C, Tomei C, Lefebvre M, Harris C, Maheu C, Lebel S. An exploratory study of the worst-case scenario exercise as an exposure treatment for fear of cancer recurrence. Support Care Cancer. 2017 May;25(5):1373-1375. doi: 10.1007/s00520-017-3600-4. Epub 2017 Feb 2. PMID 28150044
- BACKGROUNDMaheu C, Lebel S, Tomei C, Singh M, Esplen MJ. Breast and ovarian cancer survivors' experience of participating in a cognitive-existential group intervention addressing fear of cancer recurrence. Eur J Oncol Nurs. 2015 Aug;19(4):433-40. doi: 10.1016/j.ejon.2014.12.003. Epub 2014 Dec 30. PMID 25555320
- BACKGROUNDTomei C, Lebel S, Maheu C, Lefebvre M, Harris C. Examining the preliminary efficacy of an intervention for fear of cancer recurrence in female cancer survivors: a randomized controlled clinical trial pilot study. Support Care Cancer. 2018 Aug;26(8):2751-2762. doi: 10.1007/s00520-018-4097-1. Epub 2018 Mar 2. PMID 29500582
- DERIVEDLamarche J, Nissim R, Avery J, Wong J, Maheu C, Lambert SD, Laizner AM, Jones J, Esplen MJ, Lebel S. It is Time to Address Fear of Cancer Recurrence in Family Caregivers: Feasibility and Acceptability of a Randomized Pilot Study of the Family Caregiver Version of the Fear of Recurrence Therapy (FC-FORT). Psychooncology. 2025 Feb;34(2):e70084. doi: 10.1002/pon.70084. PMID 39887474
- DERIVEDLamarche J, Nissim R, Avery J, Wong J, Maheu C, Lambert SD, Laizner AM, Jones J, Esplen MJ, Lebel S. 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). Pilot Feasibility Stud. 2024 Nov 19;10(1):143. doi: 10.1186/s40814-024-01567-4.