About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Parent Fear of Recurrence Therapy (Parent-FORT)
Behavioral7 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.
Treatment groups
Trial outcomes
Primary outcomes
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 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
Secondary outcomes
Changes in Baseline Intolerance of Uncertainty Scale at 7 Weeks
Intolerance of Uncertainty Scale - Short Form (IUS-SF), range from 12-60 with higher scores indicating high levels of intolerance of uncertainty
Changes in Baseline Intolerance of Uncertainty Scale at 3 Months
Intolerance of Uncertainty Scale - Short Form (IUS-SF), range from 12-60 with higher scores indicating high levels of intolerance of uncertainty
Changes in baseline Uncertainty in Illness at 7 weeks
Mishel Uncertainty in Illness Scale Short-Form (MUIS-SF), range from 5-25 with higher scores indicating high levels of uncertainty in illness
Changes in baseline Uncertainty in Illness at 3 months
Mishel Uncertainty in Illness Scale Short-Form (MUIS-SF), range from 5-25 with higher scores indicating high levels of uncertainty in illness
Sponsors and contacts
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University of Ottawa
Lead sponsor
Children's Hospital of Eastern Ontario
Collaborator
Alberta Children's Hospital
Collaborator