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Cognitive Behavioral Therapy for Cancer Anxiety in Caregivers (FC-FORT Trial)

N/A

Waitlist Available

Led By Sophie Lebel, PhD

Research Sponsored by University of Ottawa

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up changes in baseline intolerance of uncertainty scale after 7 weeks of the intervention

Awards & highlights

FC-FORT Trial Summary

This trial will study whether an online intervention designed to help reduce fear of cancer recurrence is feasible and acceptable for family caregivers, and if it has any clinical implications on those caregivers' fear of recurrence and quality of life.

Who is the study for?

This trial is for female adult family caregivers in Canada, caring for an adult cancer survivor who has completed treatment without recurrence. Participants must have significant fear of cancer recurrence (score ≥13 on a specific inventory), access to a computer and internet, and not be involved in other support groups or have unmanaged mental health disorders.Check my eligibility

What is being tested?

The study tests an online version of Fear Of Recurrence Therapy (FC-FORT) adapted for family caregivers. It aims to check if this therapy is feasible and acceptable through recruitment, participation rates, satisfaction surveys, and interviews before moving onto a larger pilot study.See study design

What are the potential side effects?

As FC-FORT involves cognitive behavioral therapy delivered online with no medication or invasive procedures involved, there are minimal physical side effects expected. Emotional discomfort due to discussing fears may occur.

FC-FORT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ changes in baseline group cohesion through study completing (at weeks 1, 4 and 7)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~changes in baseline group cohesion through study completing (at weeks 1, 4 and 7)

This trial's timeline: 3 weeks for screening, Varies for treatment, and changes in baseline group cohesion through study completing (at weeks 1, 4 and 7) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in baseline fear of cancer recurrence after intervention

Changes in baseline fear of cancer recurrence at three months

Secondary outcome measures

Changes in Baseline Intolerance of Uncertainty Scale at 3 Months

Changes in Baseline Intolerance of Uncertainty Scale at 7 Weeks

Encounter Groups

+9 more

FC-FORT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CBT/Existential Group Therapy for Fear of Cancer RecurrenceExperimental Treatment1 Intervention

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.

Group II: Wait-list Control GroupActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Family Caregiver - Fear Of Recurrence Therapy (FC-FORT)

2021

N/A

~20

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of OttawaLead Sponsor

210 Previous Clinical Trials

268,172 Total Patients Enrolled

Sophie Lebel, PhDPrincipal InvestigatorUniversity of Ottawa

1 Previous Clinical Trials

50 Total Patients Enrolled

Media Library

Family Caregiver - Fear Of Recurrence Therapy (FC-FORT) Clinical Trial Eligibility Overview. Trial Name: NCT05441384 — N/A

Cancer Research Study Groups: CBT/Existential Group Therapy for Fear of Cancer Recurrence, Wait-list Control Group

Cancer Clinical Trial 2023: Family Caregiver - Fear Of Recurrence Therapy (FC-FORT) Highlights & Side Effects. Trial Name: NCT05441384 — N/A

Family Caregiver - Fear Of Recurrence Therapy (FC-FORT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05441384 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are engaged in this clinical experiment?

"Affirmative. Clinicaltrials.gov supports the fact that this study is presently enrolling participants, having first been posted on October 1st 2021 and updated most recently on October 26th 2022. With 36 patients being accepted across one medical centre."

Answered by AI

What are the principal goals of this research?

"The primary objective of this clinical trial, which will be assessed after a period of 7 weeks, is to measure any changes in baseline fear of cancer recurrence at three months. To further evaluate the efficacy of this intervention, secondary outcomes include alterations in Group Cohesion (GCS), Cognitive Avoidance (CAQ) and Positive Beliefs About Worrying (WWQ). All these measures are scored on numerical scales ranging from 7-35 for GSC, 25-125 for CAQ and 13-65 for WWQ respectively. Higher scores represent stronger group cohesion or more positive beliefs about worrying while higher numbers on the CAQ indicate greater"

Answered by AI

Are volunteers still being accepted for this clinical experiment?

"Affirmative, according to information published on clinicaltrials.gov this health investigation is actively searching for participants. The initial posting was made October 1st 2021 and the details were revised most recently on October 26th 2022. 36 people are needed from one site in order to complete the study."

Answered by AI

Recent research and studies

Supportive Care in CancerJournal

Examining the Preliminary Efficacy of an Intervention for Fear of Cancer Recurrence in Female Cancer Survivors: A Randomized Controlled Clinical Trial Pilot Study

Tomei, Christina, Sophie Lebel, Christine Maheu, Monique Lefebvre, and Cheryl Harris. 2018. “Examining the Preliminary Efficacy of an Intervention for Fear of Cancer Recurrence in Female Cancer Survivors: A Randomized Controlled Clinical Trial Pilot Study”. Supportive Care in Cancer. Springer Science and Business Media LLC. doi:10.1007/s00520-018-4097-1.

Supportive Care in CancerJournal

An Exploratory Study of the Worst-case Scenario Exercise as an Exposure Treatment for Fear of Cancer Recurrence

Moran, Chelsea, Christina Tomei, Monique Lefebvre, Cheryl Harris, Christine Maheu, and Sophie Lebel. 2017. “An Exploratory Study of the Worst-case Scenario Exercise as an Exposure Treatment for Fear of Cancer Recurrence”. Supportive Care in Cancer. Springer Science and Business Media LLC. doi:10.1007/s00520-017-3600-4.

European Journal of Oncology NursingJournal

Breast and Ovarian Cancer Survivors' Experience of Participating in a Cognitive-existential Group Intervention Addressing Fear of Cancer Recurrence

Maheu, Christine, Sophie Lebel, Christina Tomei, Mina Singh, and Mary Jane Esplen. 2015. “Breast and Ovarian Cancer Survivors' Experience of Participating in a Cognitive-existential Group Intervention Addressing Fear of Cancer Recurrence”. European Journal of Oncology Nursing. Elsevier BV. doi:10.1016/j.ejon.2014.12.003.

BMC CancerJournal