Parent-FORT: Fear of Cancer Recurrence therapy for parents of childhood cancer survivors
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
This pilot tests a virtual group therapy called Parent-FORT to see if it reduces fear of cancer recurrence and improves quality of life for parents of childhood cancer survivors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Ottawa Academic / other |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT06872840 on ClinicalTrials.gov |
What this trial studies
This pilot will recruit 36 parents in Canada to participate in four videoconference groups (two intervention groups and two waitlist-control groups) led by three experienced therapists. Eligible parents must score ≥13 on the FCRI-SF-P, have internet access, and be at least one month post their child's completion of active treatment. The study will measure feasibility and acceptability (recruitment, attendance, participation, and parent satisfaction) and collect preliminary clinical outcomes on fear of recurrence and quality of life. Predefined recruitment thresholds over a 15-month period will guide decisions about feasibility for a larger multicenter randomized trial.
Who should consider this trial
Good fit: Ideal candidates are English-speaking parents or primary caregivers living in Canada of a child under 18 who completed cancer treatment at least one month ago, who have clinical FCR (FCRI-SF-P ≥13) and internet access.
Not a fit: Parents who are non-English speakers, whose child is now an adult (≥18), whose child has active unstable graft-versus-host disease after transplant, who have unmanaged serious mental health conditions, or who are already in a therapist-led psychosocial group are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, Parent-FORT could reduce parents' fear of cancer recurrence and improve their quality of life using a brief virtual group format.
How similar studies have performed: Similar brief FCR interventions and group therapies have shown benefit for adult cancer survivors, but Parent-FORT is novel because these approaches have not been tested specifically with parents of childhood cancer survivors.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ottawa, Ontario
- University of Ottawa — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Sophie Lebel, PhD — University of Ottawa
- Study coordinator: Celeste Holy, B.A
- Email: choly@uottawa.ca
- Phone: 6135625800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.