Recruiting

Parent-FORT

Sponsor:

University of Ottawa

Code:

NCT06872840

Conditions

Cancer

Parent

Fear of Cancer Recurrence

CBT

Childhood Cancer Survivors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Parent Fear of Recurrence Therapy (Parent-FORT)

Study Details

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

Study ID

NCT06872840

Start date

Aug 26, 2025

Status verified date

Sep, 2025

Completion date

May 26, 2027

Anticipated

Primary completion date

Aug 26, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CBT/Existential Group Therapy for Fear of Cancer Recurrence

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.

no intervention: Waitlist Control Group

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

Interventions

Parent Fear of Recurrence Therapy (Parent-FORT)

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.

Primary outcome measure

  • Changes in baseline fear of cancer recurrence after intervention [ Time Frame: 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 [ Time Frame: Changes in baseline fear of cancer recurrence 3 months after the start of the intervention ]

Central Contacts and Locations

Central contacts

Locations

University of Ottawa

Recruiting

Ottawa, Ontario, Canada, K1N6N5

Contacts

Principal Investigator:

Sophie Lebel, PhD

More Information

Sponsor

University of Ottawa

Last update posted

Sep 22, 2025

Last verified

Sep, 2025

Keywords

  • Pilot study
  • Group Therapy
  • Virtual

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Ottawa on 2025-09-22.