Protocol of a randomized controlled trial of the fear of recurrence therapy (FORT) intervention for women with breast or gynecological cancer.
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.


METHODS
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.


METHODS
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.


CONCLUSIONS
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.


BACKGROUND
Dr. Christine Maheu registered the trial with ISRCTN registry (Registration number: ISRCTN83539618, date assigned 03/09/2014).
Ingram School of Nursing, McGill University, Montreal, Quebec, J7V 0E2, Canada. christine.maheu@mcgill.ca.|Cancer Survivorship Program, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, M5G 2C4, Canada. christine.maheu@mcgill.ca.
Christine
C
Maheu
School of Psychology, University of Ottawa, Ottawa, Ontario, K1N 6N5, Canada.
Sophie
S
Lebel
Centre for Addition and Mental Health, CB, DB Therapy & H Therapy Centre, Toronto, Ontario, M4T 1Z2, Canada.
Christine
C
Courbasson
Department of Psychology and Psychosocial Oncology Program, The Ottawa Hospital Cancer Centre, Ottawa, Ontario, K1H 8L6, Canada.
Monique
M
Lefebvre
School of Nursing, York University, Toronto, Ontario, M3J 1P3, Canada.
Mina
M
Singh
Cancer Survivorship Program, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, M5G 2C4, Canada.
Lori J
LJ
Bernstein
Auxiliary Breast Health Program, Joseph and Wolf Lebovic Health Complex, Mount Sinai Hospital, Toronto, Ontario, M5G 1X5, Canada.
Linda
L
Muraca
After Cancer Treatment Transition Clinic, Women's College Hospital, Toronto, Ontario, M5S 1B2, Canada.
Aronela
A
Benea
Integrated Cancer Program, The Ottawa Hospital, Ottawa, Ontario, K1H 8L6, Canada.
Lynne
L
Jolicoeur
Centre for Addition and Mental Health, CB, DB Therapy & H Therapy Centre, Toronto, Ontario, M4T 1Z2, Canada.
Cheryl
C
Harris
Division of Cancer Epidemiology, McGill University, Montreal, Quebec, H2W 1S6, Canada.
Agnihotram V
AV
Ramanakumar
Obstetrics and Gynecology, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, M5G 2M9, Canada.
Sarah
S
Ferguson
Daphne Cockwell School of Nursing, Ryerson University, Toronto, Ontario, M5B 2K3, Canada.
Souraya
S
Sidani
D000293:Adolescent; D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000523:psychology / Q000628:therapy*; D015928:Cognitive Behavioral Therapy; D005239:Fear / Q000523:psychology*; D005260:Female; D005833:Genital Neoplasms, Female / Q000523:psychology / Q000628:therapy*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000523:psychology / Q000628:therapy*; D013315:Stress, Psychological / Q000523:psychology / Q000628:therapy*; D017741:Survivors / Q000523:psychology
BREAST cancer; Cancer distress; Cognitive-existential group therapy; Coping; Fear of cancer recurrence; Gynecological cancer; Quality of life; Randomized clinical trial