Clinical trial · Interventional
Adapting The Fear Of Recurrence Therapy (FORT) for Parents and Establishing Acceptability and Feasibility
Addressing Fear of Cancer Recurrence in Parents of Pediatric Cancer Survivors: Adapting The Fear Of Recurrence Therapy (FORT) for Parents and Establishing Acceptability and Feasibility
- 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)
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
Conditions (5)
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 |
| CBT | — | UNRESOLVED | — |
| Childhood Cancer Survivors | — | UNRESOLVED | — |
| Fear of Cancer Recurrence | — | UNRESOLVED | — |
| Parent | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Parent Fear of Recurrence Therapy (Parent-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: Parent Fear of Recurrence Therapy (Parent-FORT)
- type
- NO_INTERVENTION
- label
- Waitlist Control Group
- description
- Participants assigned to this arm will 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
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
References
Publications (5)
- BACKGROUNDLamarche 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
- BACKGROUNDMurphy 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
- BACKGROUNDWebb 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
- BACKGROUNDSimard 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
- BACKGROUNDLebel 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