Cognitive-Existential Group Therapy to Reduce Fear of Cancer Recurrence: A RCT Study
Efficacy of a Cognitive-existential Intervention to Address Fear of Recurrence in Women With Cancer: a Randomized Controlled Clinical Trial
1 other identifier
interventional
144
1 country
3
Brief Summary
Studies show that cancer survivors have unmet needs, the most frequently cited being fear of recurrence (FCR). Moderate to high levels of FCR have been reported by as much as 49% of cancer patients and are more prevalent among women. FCR is associated with psychological distress, lower quality of life, and increased health care utilization. Little evidence exists that these problems are being addressed by current medical management.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2014
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 17, 2016
CompletedFirst Posted
Study publicly available on registry
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedFebruary 20, 2020
February 1, 2020
5.3 years
March 17, 2016
February 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fear of cancer recurrence inventory
Fear of cancer recurrence will be measured using the Fear of Cancer Recurrence Inventory (FCRI). The FCRI is a 42-item questionnaire that includes a global score as well as seven sub-scales including triggers, severity, psychological distress, functional impairment, insight, reassurance, and coping strategies. A score of 13 or greater on the nine-item severity subscale (range 0-36) indicates clinical level of FCR \[55\]. The instrument has been shown to have adequate reliability and validity (construct validity; r=0.68 to 0.77; and reliability scores; α=0.95).
up to 12 months post-intervention follow-up
Secondary Outcomes (4)
Cancer-specific distress
Pre- two weeks prior to the intervention, Post-one week after the end of the intervention, and three (T3) and six months (T4) following the end of the intervention
Perceived risk of cancer recurrence
Pre- two weeks prior to the intervention, Post-one week after the end of the intervention, and three (T3) and six months (T4) following the end of the intervention
Intolerance of uncertainty
Pre- two weeks prior to the intervention, Post-one week after the end of the intervention, and three (T3) and six months (T4) following the end of the intervention
Uncertainty in Illness
Pre- two weeks prior to the intervention, Post-one week after the end of the intervention, and three (T3) and six months (T4) following the end of the intervention
Study Arms (2)
Group 1
EXPERIMENTALBehavioral:Cognitive Existential Therapy Group 1- Weekly two-hour group sessions
Group 2
ACTIVE COMPARATORBehavioral: Supportive Therapy Group 2- Weekly two-hour group sessions
Interventions
Six group sessions of two hour each using a cognitive-existential group approach
Six group session of two hour each using a supportive group approach.
Eligibility Criteria
You may qualify if:
- first diagnosis of BC or GC with stages between I-III;
- disease-free at the start of the group;
- women aged 18 years or older;
- completion of treatment, with the exception of adjuvant chemotherapy or hormonal replacement therapy
You may not qualify if:
- non-English speakers
- previous cancer recurrence
- enrolled in another group psychotherapy at the time of the start of the study or during the course of the 6 sessions
- unresolved mental health disorder judged to be clinically contra-indicated and/or likely to affect the group work, based on disclosure by the potential participant or clinically identified by the group leader.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- McGill Universitylead
- Canadian Cancer Society (CCS)collaborator
- Princess Margaret Hospital, Canadacollaborator
- University of Ottawacollaborator
- Sir Mortimer B. Davis - Jewish General Hospitalcollaborator
Study Sites (3)
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G2C4, Canada
Jewish General Hospital
Montreal, Quebec, H3A 2A7, Canada
Related Publications (1)
Maheu C, Lebel S, Courbasson C, Lefebvre M, Singh M, Bernstein LJ, Muraca L, Benea A, Jolicoeur L, Harris C, Ramanakumar AV, Ferguson S, Sidani S. Protocol of a randomized controlled trial of the fear of recurrence therapy (FORT) intervention for women with breast or gynecological cancer. BMC Cancer. 2016 Apr 25;16:291. doi: 10.1186/s12885-016-2326-x.
PMID: 27112319BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christine Maheu, RN, PhD
McGill University and University Health Network
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 17, 2016
First Posted
September 1, 2017
Study Start
October 1, 2014
Primary Completion
February 1, 2020
Study Completion
February 1, 2020
Last Updated
February 20, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share