CBT/Existential Group Therapy for Fear of Cancer Recurrence for Malignancies

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Ottawa, Ottawa, Canada
Malignancies+4 More
Family Caregiver - Fear Of Recurrence Therapy (FC-FORT) - Behavioral
Eligibility
18+
Female
What conditions do you have?
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Study Summary

Fear of cancer recurrence (FCR) is common, persistent, and is associated with negative outcomes. Studies show that family caregivers (FC) of cancer patients experience equal or greater levels of FCR than patients themselves. In the past 5 years, several interventions have demonstrated their ability to reduce FCR among cancer patients, including a group intervention called Fear of Recurrence Therapy (FORT). However, none have ever been adapted and offered to caregivers. The goals of the proposed study are to demonstrate 1) that a newly adapted intervention of FORT (FC-FORT) is feasible (i.e., participant recruitment, attendance and participation) and acceptable (i.e., FC satisfaction of the intervention) for a larger study, and 2) the clinical implications of FC- FORT on FCR and quality of life. An advisory board composed of researchers, therapists, and FC was created to adapt FORT for FC and to an online format. FC and therapists are currently being recruited to conduct a usability study of the newly adapted FC-FORT. They will be asked to complete a session feedback questionnaire after each session and to take part in an exit interview. The content of these will be summarized back to the advisory board in order to further refine FC-FORT. Following a successful usability study, FC-FORT will be given to four groups of nine new FC (pilot study). Participants will be recruited directly by clinicians and by outreach mailout efforts. They will complete a questionnaire package before and after the intervention, as well as at a three month follow up. The proposed study is needed to determine if an already developed FCR intervention can be adapted to family caregivers and if it can be successfully pilot tested. This will help bridge an important gap in bringing evidence-based care to caregivers who have never been offered help before for their FCR. The proposed project will also allow to further feasibility and acceptability of E-Health interventions.

Eligible Conditions

  • Malignancies
  • Fear Cancer
  • Caregivers
  • CBT

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 14 Secondary · Reporting Duration: Changes in baseline perceived risk of recurrence through study completing (once per week for 7 weeks)

Month 3
Changes in baseline avoidance at 3 months
Week 7
Changes in Baseline Intolerance of Uncertainty Scale at 7 Weeks
Changes in baseline Uncertainty in Illness at 7 weeks
Month 3
Changes in Baseline Intolerance of Uncertainty Scale at 3 Months
Changes in baseline Uncertainty in Illness at 3 months
Week 7
Changes in baseline Positive Beliefs About Worrying at 7 weeks
Month 3
Changes in baseline Positive Beliefs About Worrying at 3 months
Week 7
Changes in baseline avoidance at 7 weeks
Month 3
Changes in baseline fear of cancer recurrence at three months
Week 7
Changes in baseline fear of cancer recurrence after intervention
Week 7
Weekly changes in Group Cohesion
Week 7
Weekly changes in satisfaction with the intervention
Week 7
Weekly changes in Perceived Risk of Cancer Recurrence
Week 7
Changes in baseline Protective Buffering at 7 weeks
Month 3
Changes in baseline Protective Buffering at 3 months
Week 7
Weekly changes in Therapeutic Alliance

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Wait-list Control Group
1 of 2
CBT/Existential Group Therapy for Fear of Cancer Recurrence
1 of 2
Active Control
Experimental Treatment

36 Total Participants · 2 Treatment Groups

Primary Treatment: CBT/Existential Group Therapy for Fear of Cancer Recurrence · No Placebo Group · N/A

CBT/Existential Group Therapy for Fear of Cancer Recurrence
Behavioral
Experimental Group · 1 Intervention: Family Caregiver - Fear Of Recurrence Therapy (FC-FORT) · Intervention Types: Behavioral
Wait-list Control GroupNoIntervention Group · 1 Intervention: Wait-list Control Group · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: changes in baseline perceived risk of recurrence through study completing (once per week for 7 weeks)

Trial Background

Prof. Sophie Lebel, Professor
Principal Investigator
University of Ottawa
Closest Location: University of Ottawa · Ottawa, Canada
Photo of Ottawa  1Photo of Ottawa  2Photo of Ottawa  3
2004First Recorded Clinical Trial
4 TrialsResearching Malignancies
30 CompletedClinical Trials

Eligibility Criteria

Age 18+ · Female Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a female adult FC caring for an adult cancer survivor of any type of cancer type, stages I-III, who has completed treatments and has not had a recurrence of their cancer; you are aged 18 years or older.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References