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

NCT05441384 | Completed

• 1 other identifier: H-05-20-5584
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pilot Study; Group Therapy; Virtual

Outcome Measures

Primary Outcomes (2)

• Changes in baseline fear of cancer recurrence after intervention

  Fear of Cancer Recurrence Inventory - Short Form (FCR-SF), range from 0-36 with higher scores indicating high levels of fear of cancer recurrence

  Changes in baseline fear of cancer recurrence 7 weeks after the start of the intervention

• Changes in baseline fear of cancer recurrence at three months

  Fear of Cancer Recurrence Inventory - Short Form (FCR-SF), range from 0-36 with higher scores indicating high levels of fear of cancer recurrence

  Changes in baseline fear of cancer recurrence 3 months after the start of the intervention

Secondary Outcomes (12)

• Changes in Baseline Intolerance of Uncertainty Scale at 7 Weeks

  Changes in baseline Intolerance of Uncertainty Scale after 7 weeks of the intervention

• Changes in Baseline Intolerance of Uncertainty Scale at 3 Months

  Changes in baseline Intolerance of Uncertainty Scale at 3 month after the completion of the intervention

• Changes in baseline Uncertainty in Illness at 7 weeks

  Changes in baseline Intolerance of Uncertainty Scale after 7 weeks of the intervention

• Changes in baseline Uncertainty in Illness at 3 months

  Changes in baseline Intolerance of Uncertainty Scale at 3 month after the completion of the intervention

• Changes in baseline Positive Beliefs About Worrying at 7 weeks

  Changes in baseline Positive Beliefs About Worrying after 7 weeks of the intervention

Study Arms (2)

CBT/Existential Group Therapy for Fear of Cancer Recurrence

EXPERIMENTAL

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.

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

Wait-list Control Group

NO INTERVENTION

Participants assigned to this arm wait about 3-months to receive the intervention.

Interventions

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

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.

CBT/Existential Group Therapy for Fear of Cancer Recurrence

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Individuals identifying as female.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Ottawa: lead

Study Sites (1)

University of Ottawa

Ottawa, Ontario, K1N6N5, Canada

Location

Related Publications (6)

• Maheu 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 BACKGROUND

• Moran 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 BACKGROUND

• Maheu 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 BACKGROUND

• Tomei 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 BACKGROUND

• Lamarche 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 DERIVED

• Lamarche 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.

  PMID: 39563465 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Neoplasms; Pathophobia

Study Officials

• Sophie Lebel, PhD

  University of Ottawa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: July 1, 2022
• Study Start: October 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: March 1, 2024
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)