Breast Cancer Clinical Trial
Official title:
Investigation of Three Approaches to Address Fear of Recurrence Among Breast Cancer Survivors: A Randomized Clinical Pilot Trial
Fear of cancer recurrence (FCR) is one of the most prevalent, persistent, and disruptive sources of distress for adult cancer survivors. Prevalence rates for FCR have been estimated at up to 89%, with approximately half of cancer survivors reporting clinically significant levels of FCR. Despite the recognized prevalence, persistence, and suffering associated with FCR, effective and accessible treatments for FCR are lacking and urgently needed. Our long-term goal is to develop, evaluate, and implement effective behavioral interventions for cancer survivors suffering with FCR.
The proposed randomized pilot study will assess the effects of a novel therapeutic
intervention—Acceptance and Commitment Therapy (ACT)—for breast cancer survivors (BCS) with
clinically-significant FCR. ACT is a spiritually-sensitive behavioral therapy that has shown
efficacy in the treatment of anxiety in non-cancer populations, and preliminary efficacy in
improving a variety of outcomes among adults with cancer. ACT uses mindfulness and acceptance
processes, along with committed behavior change in service of an individual's deeply held
values to enhance psychological flexibility and encourage adaptive coping with life
challenges, such as cancer.
The primary objective of the proposed 3-arm randomized controlled pilot trial is to assess
the feasibility/acceptability and determine preliminary effect size estimates of ACT in
preparation for a fully-powered efficacy trial. To allow for potential drop out (15%
attrition) and ensure we have a minimum of 78 completers through the end of the trial, we
will enroll approximately 91 BCS with clinically significant FCR (defined by score ≥ 13 on
Fears of Cancer Recurrence Inventory-Short Form). Participants will be randomized to one of
three groups: (1) a 6-week ACT intervention group (n=26); (2) a 6-week survivorship education
group (SE; n=26); or (3) enhanced usual care (EUC; n=26). The impact of ACT, SE, and EUC on
survivors' FCR and associated psychological, spiritual, and biological (telomere length)
outcomes will be examined at baseline (T1), post-intervention (T2), and at 1-month (T3) and
6-month follow-up (T4) with the following specific aims:
Aim 1: Evaluate feasibility and acceptability of ACT, SE, and EUC according to the:
1. Percentage of eligible BCS who consent to participate in the trial;
2. Attendance rate across 6 sessions of ACT and SE;
3. Retention rate through T4 in the ACT, SE, and EUC arms;
4. Mean ratings across groups for intervention satisfaction and helpfulness for managing
FCR.
Aim 2: Determine pairwise effect size estimates of ACT, SE, and EUC effects at each time
point (T2, T3, T4) adjusted for T1 on the:
1. Primary outcome: reducing FCR;
2. Secondary psychological outcomes: cancer-related experiential avoidance, cognitive
avoidance, anxiety, depression, post-traumatic stress symptoms, vitality, breast cancer
self-efficacy, and quality of life;
3. Secondary spiritual outcomes: spiritual well-being and mindfulness;
4. Secondary biological outcome: telomere length.
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