NCT06872840 Adapting The Fear Of Recurrence Therapy (FORT) for Parents and Establishing Acceptability and Feasibility
| NCT ID | NCT06872840 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Ottawa |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2025-08-26 |
| Primary Completion | 2026-08-26 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 36 participants in total. It began in 2025-08-26 with a primary completion date of 2026-08-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Sophie Lebel, PhD
PRINCIPAL INVESTIGATOR
University of Ottawa
Frequently Asked Questions
Who can join the NCT06872840 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06872840 currently recruiting?
Yes, NCT06872840 is actively recruiting participants. Contact the research team at choly@uottawa.ca for enrollment information.
Where is the NCT06872840 trial being conducted?
This trial is being conducted at Ottawa, Canada.
Who is sponsoring the NCT06872840 clinical trial?
NCT06872840 is sponsored by University of Ottawa. The principal investigator is Sophie Lebel, PhD at University of Ottawa. The trial plans to enroll 36 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.