Grant Number:	5R01CA255480-02 Interpret this number
Primary Investigator:	Johns, Shelley
Organization:	Indiana University Indianapolis
Project Title:	Acceptance and Commitment Therapy for Fear of Recurrence in Breast Cancer Survivors
Fiscal Year:	2022

PROJECT SUMMARY / ABSTRACT Following treatment for early-stage cancer, most survivors fear the possibility of a recurrence. While mild and intermittent for many, these fears become clinically significant for approximately 40% of survivors, adversely affecting mood, coping, and quality of life while simultaneously increasing healthcare use and associated costs. Particularly vulnerable are breast cancer survivors (BCS) who are 33% more likely to report clinically significant fear of cancer recurrence (FCR) than other survivors. Additionally, FCR is the top unmet need among BCS, yet evidence-based treatments for FCR are lacking. Cognitive Behavioral Therapy (CBT) has been the most frequently tested intervention for FCR, yielding modest effect sizes. A theoretically distinct approach that may be better suited to BCS' experiences with FCR is Acceptance and Commitment Therapy (ACT). The goal of ACT is to increase psychological flexibility so that difficult internal experiences (e.g., fearful thoughts and feelings) interfere less with meaningful activities and quality of life. Psychological flexibility is comprised of mindfulness/acceptance processes (i.e., compassionate attention to the present moment) and commitment/behavior change processes (i.e., identifying and acting in line with personal values). Our team conducted a 3-arm pilot randomized controlled trial in BCS with clinical FCR comparing group-based ACT to an attention-matched survivorship education (SE) group and enhanced usual care (EUC; brief coaching with self-administered readings). Rapid recruitment (91 BCS in 12 weeks) and high retention (94.5% through 6 months) demonstrated outstanding feasibility. Our 6-week ACT intervention was superior to SE and EUC in reducing FCR and improving several other outcomes at 6 months post-intervention. Based on these promising pilot trial results, we propose a 3-arm phase III randomized controlled trial of ACT compared to CBT and EUC for early stage (I-IIIA) BCS 0-5 years post-treatment (N=375) reporting clinically significant FCR. All interventions will be delivered via videoconferencing. Using the Indiana State Cancer Registry and Indiana Network for Patient Care database, we will recruit BCS from five oncology facilities, including one that specializes in the care of racially, ethnically, and economically diverse survivors. Specific aims are to: (1) test the efficacy of group-based ACT compared to CBT and EUC on FCR (primary outcome) and anxiety, depressive symptoms, post-traumatic stress, avoidant coping, and quality of life (secondary outcomes) over 12 months; (2) examine change in psychological flexibility as a mediator of ACT's effects on FCR over 12 months; and (3) perform comparative assessment of ACT, CBT, and EUC to determine the cost-effective intervention for FCR. Our ability to demonstrate ACT's efficacy will lead to its widespread dissemination to BCS. Findings will also inform further application and refined testing of ACT with various cancer populations and health- related outcomes.





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