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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Investigation of Three Approaches to Address Fear of Recurrence Among Breast Cancer Survivors: A Randomized Clinical Pilot Trial

Brief 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 Summary:

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. As measured by Fear of Cancer Recurrence Inventory (FCRI)


Original Primary Outcome: Change from baseline in fear of recurrence (FCR) at Post-Intervention, 1-month, and 6-month follow-up [ Time Frame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4) ]

As measured by Fear of Cancer Recurrence Inventory (FCRI)


Current Secondary Outcome:

  • Change from baseline in fear of recurrence (FCR) at Post-Intervention, 1-month, and 6-month follow-up as assessed by Concerns about Recurrence Scale (CARS). [ Time Frame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4) ]
    As measured by Concerns about Recurrence Scale (CARS)
  • Change from baseline in experiential avoidance at Post-Intervention, 1-month, and 6-month follow-up as assessed by Acceptance & Action Questionnaire-II (AAQ-II). [ Time Frame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4) ]
    As measured by Acceptance & Action Questionnaire-II (AAQ-II)
  • Change from baseline in cognitive avoidance at Post-Intervention, 1-month, and 6-month follow-up as assessed by Mini-Mental Adjustment to Cancer Scale (Mini-MAC). [ Time Frame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4) ]
    As measured by Mini-Mental Adjustment to Cancer Scale (Mini-MAC)
  • Change from baseline in anxiety at Post-Intervention, 1-month, and 6-month follow-up as assessed by Generalized Anxiety Disorder Scale (GAD-7). [ Time Frame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4) ]
    As measured by Generalized Anxiety Disorder Scale (GAD-7)
  • Change from baseline in depression at Post-Intervention, 1-month, and 6-month follow-up as assessed by as measured by Patient Health Questionnaire Depression Scale (PHQ-8). [ Time Frame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4) ]
    As measured by Patient Health Questionnaire Depression Scale (PHQ-8)
  • Change from baseline in post-traumatic stress symptoms at Post-Intervention, 1-month, and 6-month follow-up as assessed by Impact of Events Scale-Revised (IES-R). [ Time Frame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4) ]
    As measured by Impact of Events Scale-Revised (IES-R)
  • Change from baseline in vitality at Post-Intervention, 1-month, and 6-month follow-up as assessed by Short Form(SF)-36 Vitality Scale. [ Time Frame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4) ]
    As measured by Short Form(SF)-36 Vitality Scale
  • Change from baseline in Breast Cancer Self-Efficacy at Post-Intervention, 1-month, and 6-month follow-up as assessed by Breast Cancer Self-Efficacy Scale [ Time Frame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4) ]
    As measured by Breast Cancer Self-Efficacy Scale
  • Change from baseline in quality of life at Post-Intervention, 1-month, and 6-month follow-up as assessed by McGill Quality of Life—general item [ Time Frame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4) ]
    As measured by McGill Quality of Life—general item
  • Change from baseline in spiritual well-being at Post-Intervention, 1-month, and 6-month follow-up as assessed by Functional Assessment of Chronic Illness Therapy-Spiritual Well-being (FACIT-Sp) [ Time Frame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4) ]
    As measured by Functional Assessment of Chronic Illness Therapy- Spiritual Well-being (FACIT-Sp)
  • Change from baseline in mindfulness at Post-Intervention, 1-month, and 6-month follow-up as assessed by Five Factor Mindfulness Questionnaire-Short Form [ Time Frame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4) ]
    As measured by Five Factor Mindfulness Questionnaire-Short Form
  • Change from baseline in telomere length at Post-Intervention, 1-month, and 6-month follow-up as assessed by Quantitative telomere length. [ Time Frame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4) ]
    As measured by Quantitative telomere length.
  • Intervention ratings at Post-Intervention as assessed by Client Satisfaction Questionnaire (CSQ-8) [ Time Frame: post-intervention/6-weeks (T2) ]
    As measured by Client Satisfaction Questionnaire (CSQ-8)


Original Secondary Outcome:

  • Change from baseline in fear of recurrence (FCR) at Post-Intervention, 1-month, and 6-month follow-up [ Time Frame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4) ]
    As measured by Concerns about Recurrence Scale (CARS)
  • Change from baseline in experiential avoidance at Post-Intervention, 1-month, and 6-month follow-up. [ Time Frame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4) ]
    As measured by Acceptance & Action Questionnaire-II (AAQ-II)
  • Change from baseline in cognitive avoidance at Post-Intervention, 1-month, and 6-month follow-up. [ Time Frame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4) ]
    As measured by Mini-Mental Adjustment to Cancer Scale (Mini-MAC)
  • Change from baseline in anxiety at Post-Intervention, 1-month, and 6-month follow-up. [ Time Frame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4) ]
    As measured by Generalized Anxiety Disorder Scale (GAD-7)
  • Change from baseline in depression at Post-Intervention, 1-month, and 6-month follow-up. [ Time Frame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4) ]
    As measured by Patient Health Questionnaire Depression Scale (PHQ-8)
  • Change from baseline in post-traumatic stress symptoms at Post-Intervention, 1-month, and 6-month follow-up. [ Time Frame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4) ]
    As measured by Impact of Events Scale-Revised (IES-R)
  • Change from baseline in vitality at Post-Intervention, 1-month, and 6-month follow-up. [ Time Frame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4) ]
    As measured by Short Form(SF)-36 Vitality Scale
  • Change from baseline in breast cancer self-efficacy at Post-Intervention, 1-month, and 6-month follow-up. [ Time Frame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4) ]
    As measured by Breast Cancer Self-Efficacy Scale
  • Change from baseline in quality of life at Post-Intervention, 1-month, and 6-month follow-up. [ Time Frame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4) ]
    As measured by McGill Quality of Life—general item
  • Change from baseline in spiritual well-being at Post-Intervention, 1-month, and 6-month follow-up. [ Time Frame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4) ]
    As measured by Functional Assessment of Chronic Illness Therapy- Spiritual Well-being (FACIT-Sp)
  • Change from baseline in mindfulness at Post-Intervention, 1-month, and 6-month follow-up. [ Time Frame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4) ]
    As measured by Five Factor Mindfulness Questionnaire-Short Form
  • Change from baseline in telomere length at Post-Intervention, 1-month, and 6-month follow-up. [ Time Frame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4) ]
    As measured by Quantitative polymerase chain reaction
  • Intervention ratings at Post-Intervention. [ Time Frame: post-intervention/6-weeks (T2) ]
    As measured by Client Satisfaction Questionnaire (CSQ-8)


Information By: Indiana University

Dates:
Date Received: November 16, 2015
Date Started: December 2015
Date Completion: June 2017
Last Updated: December 9, 2015
Last Verified: December 2015