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

Abstract

BackgroundClinically 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.MethodsSixteen 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.DiscussionOur 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 registrationDr. Christine Maheu registered the trial with ISRCTN registry (Registration number: ISRC...

Effect of lymphedema self-management group-based education compared with social network-based education on quality of life and fear of cancer recurrence in women with breast cancer: a randomized controlled clinical trial

“…FCR is defined as fear and concern about the return or progression of cancer in the same organ or any other parts of the body [8], affecting one-third of people with cancer [9]. Some degree of FCR is expected and adaptive (incentive to continue treatment).…”

“…It can disrupt the everyday life of these people as a result of creating stress, difficulty in acceptance, psychological responses, functional disorders, physical disorders, as well as exacerbation of existing mental disorders [7,8]. A high level of fear is a reason for avoiding referral to specialized cancer centers and continuing treatment [9] and produces disturbing thoughts and anxiety in women with lymphedema which evokes worry about their future [10]. FCR is one of the factors that reduce adherence to self-management behaviors in lymphedema [10][11][12].…”

A pilot randomized controlled trial of cognitive bias modification to reduce fear of breast cancer recurrence

“…3,4,6 Despite this, to the best of our knowledge, to date, few psychosocial interventions have been designed to target FCR. [8][9][10] In fact, BCS report that their greatest unmet need is the management of FCR. 11 Cognitive models of anxiety posit that cognitive biases, such as selective attention to threat-relevant stimuli (attention bias) 12 and interpreting ambiguity in a threatening manner (interpretation bias), 13 play a key role in the etiology and maintenance of maladaptive levels of anxiety.…”

Quality of Life Among Cancer Survivors

“…Although considerable research has addressed different therapeutic interventions and quality of life among cancer survivors (Fitzpatrick, 2016;Fitzpatrick & Farone, 2011;Edgar, 2016;Fitch, 2009;Fitzpatrick & Remmer, 2011), the field of cancer survivorship is relatively new and remains an emerging field (Jezer-Morton, 2015;Mayo, 2001;Maheu, 2016). Mayo (2015) believes that one of the reasons is that no one profession has taken it on.…”

“…Although cancer survivors have an increasingly longer life span due to more advanced medical treatment and care, emotional and physical challenges and barriers to treatment are a constant reminder of the day-to-day struggle to survive. A good number of cancer survivors experience the fear of recurrence (Maheu, 2016), physical symptoms of pain and fatigue, cognitive and memory impairment, plus symptoms related to their particular type of cancer effecting their quality of life (Mititelu, Aruljothy & Fitzpatrick, 2016).…”