Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: Investigation of Three Approaches to Address Fear of Recurrence Among Breast Cancer Survivors

Summary: 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.

Detailed description: 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. A total of 78 BCS who have completed curative treatment and who report clinically-significant FCR (defined by score ≥ 13 on Fears of Cancer Recurrence Inventory-Short Form) 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) usual care (UC; n=26). The impact of ACT, SE, and UC on survivors' FCR and associated psychological, spiritual, and biological (telomere length) outcomes will be examined at baseline (T1), post-intervention (T2), 1-month (T3), and 6-month follow-up (T4) with the following specific aims:
  Aim 1: Evaluate the feasibility and acceptability of ACT, SE, and UC 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 UC 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 UC effects at each time point (T2, T3, T4) adjusted for T1 on the:
  1. Primary outcome: reducing FCR;
  2. Secondary psychological outcomes: 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.

Eligibility: Inclusion Criteria: Participants in this study will be eligible if they are:
  1. age ≥18 years,
  2. have been diagnosed with non-metastatic breast cancer (stages 0-III),
  3. have completed curative treatment for breast cancer,
  4. have not experienced a cancer recurrence, and
  5. report a clinically significant level of FCR (as assessed with the Fear of Cancer Recurrence Inventory-Short Form ≥ 13)
  Exclusion Criteria:
  1. severe depression (PHQ-8 ≥ 20),
  2. past participation in ACT or formal mindfulness training, and
  3. limited English proficiency.

Relevance to patient case: not relevant