Investigation of Three Approaches to Address Fear of Recurrence Among Breast Cancer Survivors
Condition: Breast Neoplasms; Breast Cancer; Breast Carcinoma; Malignant Neoplasm of Breast; Cancer of Breast; Mammary Neoplasm, Human; Human Mammary Carcinoma; Malignant Tumor of Breast; Mammary Cancer; Mammary Carcinoma; Anxiety; Fear; Neoplasm Remission, Spontaneous; Spontaneous Neoplasm Regression; Regression, Spontaneous Neoplasm; Remission, Spontaneous Neoplasm; Spontaneous Neoplasm Remission
MeSH terms: Carcinoma; Breast Neoplasms; Neoplasms; Mammary Neoplasms, Animal; Neoplasm Regression, Spontaneous; Recurrence; Remission, Spontaneous
Study type: Interventional

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. 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.
    

Intervention name(s): Acceptance and Commitment Therapy; Survivorship Education; Enhanced Usual Care
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 6-week ACT intervention group (n=33); 6-week survivorship education group (SE; n=32); enhanced usual care (EUC; n=26)
Other intervention name(s): ACT; SE; EUC
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Fear of Cancer Recurrence; Fear of Cancer Return; Breast Cancer Survivor; Breast Cancer Remission