Adapting The Fear Of Recurrence Therapy (FORT) for Parents and Establishing Acceptability and Feasibility

NCT06872840 | Recruiting

• 2 other identifiers: H-08-24-10241506459
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical levels of fear of cancer recurrence (FCR) affect up to 59% of adult cancer survivors. Family caregivers experience equal or greater levels of FCR, which has been linked to lower quality of life and increased distress. FCR can be addressed in cancer survivors with brief interventions. However, none of these interventions have been tested with parents of childhood cancer survivors. This is an urgent gap: the survival rates of childhood cancer have increased more rapidly than for adult cancers, resulting in a growing population of childhood cancer survivors who, along with their families, need support. The goals of this pilot study are to demonstrate 1) that a newly adapted intervention of FORT (Parent-FORT) is feasible (i.e., participant recruitment, attendance and participation) and acceptable (i.e., parent satisfaction of the intervention) for a larger study, and 2) the clinical implications of Parent-FORT on fear of cancer recurrence (FCR) and quality of life in parents of childhood cancer survivors. Parents will be randomly assigned to participate in the Parent-FORT intervention immediately or a three-month waitlist control group. They will complete a questionnaire package before and after the intervention, as well as at a three month follow up. This study will help bridge an important gap in bringing evidence-based care to parents who have never been offered help before for their FCR.

Conditions

Cancer; Parent; Fear of Cancer Recurrence; CBT; Childhood Cancer Survivors

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 - Parent (FCRI-P), 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 - Parent (FCRI-P), 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 (16)

• 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: Parent Fear of Recurrence Therapy (Parent-FORT)

Waitlist Control Group

NO INTERVENTION

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

Interventions

Parent Fear of Recurrence Therapy (Parent-FORT) BEHAVIORAL

7 weekly sessions of 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+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parent (or primary caregiver) caring for a childhood cancer survivor (\<18 years of age) of any type of cancer type, who is at least 1 months from the completion of active treatment and has not had a recurrence of their cancer
• A score of 13 or greater on the Fear of Cancer Recurrence Inventory-Short Form-Parent version (FCRI-SF-P; range 0-36), suggesting clinical levels of FCR
• Access to a computer and internet connection
• Living in Canada

You may not qualify if:

• Being the parent of a pediatric cancer survivor who is now 18 years of age or older
• Being the parent of a pediatric cancer survivor who has undergone hematopoietic cell transplantation and has active chronic or acute graft-versus-host disease which has not stabilized for at least 3 months
• Non-English speakers
• Currently participating in another therapist-led psychosocial therapy group
• Parent with unmanaged/undermanaged mental health disorder judged to be clinically contraindicated and/or likely to affect the group work
• To avoid violating the assumption of nonindependence of the data, only one parent/caregiver per child can participate in the study.

Sponsors & Collaborators

• University of Ottawa: lead
• Children's Hospital of Eastern Ontario: collaborator
• Alberta Children's Hospital: collaborator

Study Sites (1)

University of Ottawa

Ottawa, Ontario, K1N6N5, Canada

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• Murphy LK, Heathcote LC, Prussien KV, Rodriguez EM, Hewitt JA, Schwartz LE, Ferrante AC, Gerhardt CA, Vannatta K, Compas BE. Mother-child communication about possible cancer recurrence during childhood cancer survivorship. Psychooncology. 2021 Apr;30(4):536-545. doi: 10.1002/pon.5600. Epub 2020 Dec 3.

  PMID: 33227159 BACKGROUND

• Webb K, Sharpe L, Butow P, Dhillon H, Zachariae R, Tauber NM, O'Toole MS, Shaw J. Caregiver fear of cancer recurrence: A systematic review and meta-analysis of quantitative studies. Psychooncology. 2023 Aug;32(8):1173-1191. doi: 10.1002/pon.6176. Epub 2023 Jun 11.

  PMID: 37303263 BACKGROUND

• Simard S, Thewes B, Humphris G, Dixon M, Hayden C, Mireskandari S, Ozakinci G. Fear of cancer recurrence in adult cancer survivors: a systematic review of quantitative studies. J Cancer Surviv. 2013 Sep;7(3):300-22. doi: 10.1007/s11764-013-0272-z. Epub 2013 Mar 10.

  PMID: 23475398 BACKGROUND

• Lebel S, Ozakinci G, Humphris G, Mutsaers B, Thewes B, Prins J, Dinkel A, Butow P; University of Ottawa Fear of Cancer Recurrence Colloquium attendees. From normal response to clinical problem: definition and clinical features of fear of cancer recurrence. Support Care Cancer. 2016 Aug;24(8):3265-8. doi: 10.1007/s00520-016-3272-5. Epub 2016 May 12.

  PMID: 27169703 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Neoplasms

Study Officials

• Sophie Lebel, PhD

  University of Ottawa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Celeste Holy, B.A

CONTACT

6135625800; choly@uottawa.ca

Sophie Lebel, PhD

CONTACT

6135625800; slebel@uottawa.ca

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: March 1, 2025
• First Posted: March 12, 2025
• Study Start: August 26, 2025
• Primary Completion (Estimated): August 26, 2026
• Study Completion (Estimated): May 26, 2027
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)