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open access:
(Canada) Protocol of a randomized controlled trial of the fear of recurrence therapy (FORT) intervention for women with breast or gynecological cancer | BMC Cancer | Full Text
BMC Cancer 2016 16:291
Published on: 25 April 2016
Participant recruitment
We are recruiting 144 BC or GC survivors from four hospital sites: Princess Margaret Hospital and Mount Sinai Hospital in Toronto, Ontario, the Ottawa Hospital in Ottawa, Ontario, and the Jewish General Hospital in Montreal, Quebec.
Trial registration
Dr. Christine Maheu registered the trial with ISRCTN registry (Registration number: ISRCTN83539618, date assigned 03/09/2014).
- Condition category
- Cancer
- Date applied
- 31/07/2014
- Date assigned
- 03/09/2014
- Last edited
- 27/04/2016
- Prospective/Retrospective
- Prospectively registered
- Overall trial status
- Ongoing
- Recruitment status
- Recruiting
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Canadian Cancer Society grant # 702985
Background
Clinically significant levels
of fear of cancer recurrence (FCR) affect up to 49 % of cancer survivors
and are more prevalent among women. FCR is associated with
psychological distress, lower quality of life, and increased use of
medical resources. Despite its prevalence, FCR is poorly addressed in
clinical care. To address this problem, we first developed, and pilot
tested a 6-week, 2 h, Cognitive-existential group intervention therapy
that targeted FCR in survivors of breast or gynecological cancer.
Following the positive outcome of the pilot, we are now testing this
approach in a randomized clinical trial (RCT).
Goal and hypotheses:
This multicenter, prospective RCT aims to test the efficacy of the
intervention. The study hypotheses are that, compared to a control
group, cancer survivors participating in the intervention (1) will have
less FCR, (2) will show more favorable outcomes on the following
measures: cancer-specific distress, quality of life, illness
uncertainty, intolerance of uncertainty, perceived risk of cancer
recurrence, and coping skills. We further postulate that the
between-group differences will persist three and 6 months
post-intervention.
Methods Sixteen groups of seven to nine women are being allocated to the intervention or the control group. The control group receives a 6-week, 2 h, structurally equivalent support group. We are recruiting 144 cancer survivors from four hospital sites in three Canadian cities. The sample size was based on the moderate pre/post-test changes found in our pilot study and adjusted to the drop-out rates.
Measurements: The primary outcome, FCR, is measured by the Fear of Cancer Recurrence Inventory. Secondary outcomes measured include cancer-specific distress, perceived risk of cancer recurrence, illness uncertainty, intolerance of uncertainty, coping, and quality of life. We use reliable and recognized valid scales. Participants are to complete the questionnaire package at four times: before the first group session (baseline), immediately after the sixth session, and 3 and 6 months post-intervention. Analysis: In the descriptive analysis, comparison of group equivalent baseline variables, identification of confounding/intermediate variables and univariate analysis are planned. Each participant’s trajectory is calculated using Generalized Estimating Equation models to determine the time and group effects, after considering the correlation structures of the groups. An intent-to-treat analysis approach may be adopted.
Discussion Our Fear of Recurrence Therapy (FORT) intervention has direct implications for clinical service development to improve the quality of life for patients with breast (BC) and gynecological cancer (GC). Based on our pilot data, we are confident that the FORT intervention can guide the development of effective psychosocial cancer survivorship interventions to reduce FCR and improve psychological functioning among women with BC or GC.
Trial registration
Dr. Christine Maheu registered the trial with ISRCTN registry (Registration number: ISRCTN83539618, date assigned 03/09/2014).
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