Adapting The Fear Of Recurrence Therapy (FORT) for Parents and Establishing Acceptability and Feasibility

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Ottawa

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Parent Fear of Recurrence Therapy (Parent-FORT)

    Behavioral

    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.

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: CBT/Existential Group Therapy for Fear of Cancer RecurrenceExperimental treatment 1 intervention
Group B: Waitlist Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Changes in baseline fear of cancer recurrence 7 weeks after the start of the intervention
2

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

Time frame
Changes in baseline fear of cancer recurrence 3 months after the start of the intervention

Secondary outcomes

1

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

Time frame
Changes in baseline Intolerance of Uncertainty Scale after 7 weeks of the intervention
2

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

Time frame
Changes in baseline Intolerance of Uncertainty Scale at 3 month after the completion of the intervention
3

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

Time frame
Changes in baseline Intolerance of Uncertainty Scale after 7 weeks of the intervention
4

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

Time frame
Changes in baseline Intolerance of Uncertainty Scale at 3 month after the completion of the intervention

Other outcomes

Sponsors and contacts

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University of Ottawa

Lead sponsor

Children's Hospital of Eastern Ontario

Collaborator

Alberta Children's Hospital

Collaborator