NCT05364450

Facilitating Adaptive Coping With Fear of Recurrence Among Breast Cancer Survivors

Acceptance and Commitment Therapy for Fear of Recurrence in Breast Cancer Survivors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 390 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Fear of cancer recurrence (FCR) is a highly prevalent, disruptive, and under-treated problem for breast cancer survivors. This randomized controlled trial will test the efficacy of group-based Acceptance and Commitment Therapy compared to Cognitive Behavioral Therapy and enhanced usual care for breast cancer survivors suffering from FCR while examining its cost-effectiveness and the mechanisms by which the intervention may work. Study findings will guide the future care of breast cancer survivors with FCR.

Detailed description

The primary objective of this 3-arm randomized control trial (RCT) is to build on the investigators' pilot work by testing the impact of Acceptance Commitment Therapy (ACT) on FCR. The investigators will randomly assign up to 375 early-stage Breast Cancer Survivors (BCS; for at least 300 study completers after attrition) who have finished primary cancer treatment and who report clinically significant FCR to: (1) group-based ACT (6 weekly 1.5-hour videoconference sessions), (2) group-based Cognitive Behavioral Therapy (CBT; 6 weekly 1.5-hour videoconference sessions), or (3) Enhanced Usual Care (EUC; a single 90-minute videoconference coaching session with self-administered readings). Outcomes will be assessed at baseline and at 2, 6, and 12 months; additionally, potential theory-driven mediators of the ACT intervention's effects on key outcomes will be analyzed at these time points and at intervention midpoint. Cost-effectiveness of each intervention will be assessed. 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, fatigue, sleep disturbance, and quality of life (secondary outcomes) in BCS with clinical FCR; (2) to examine changes in psychological flexibility as a mediator of ACT's effect on FCR; and (3) to perform comparative assessments of ACT, CBT, and EUC to determine the cost-effective intervention.

Conditions

• Breast Neoplasm
• Breast Cancer
• Breast Carcinoma
• Malignant Neoplasm of Breast
• Cancer of Breast
• Mammary Neoplasms, Human
• Human Mammary Carcinoma
• Malignant Tumor of Breast
• Mammary Cancer
• Mammary Carcinoma, Human
• Anxiety
• Fear

Interventions

Type	Name	Description
BEHAVIORAL	Enhanced Usual Care	Interventionists will provide a brief explanation of the intervention and coaching to the group on how to utilize the resources provided. Prior to the single session group, EUC participants will have received a workbook with the National Cancer Institute's "Facing Forward: Life After Cancer Treatment" booklet on maximizing quality of life during cancer survivorship and the American Society of Clinical Oncology's "Guide to Cancer Survivorship."
BEHAVIORAL	Acceptance Commitment Therapy	Interventionists will support participants in adopting a psychologically flexible posture toward FCR through six interdependent processes of change - acceptance, cognitive defusion, mindfulness, perspective taking, values, and committed action. During ACT sessions, participants will learn to respond adaptively to FCR by being more fully aware of thoughts, feelings, and bodily sensations without judging or attempting to control or avoid them. Participants will also clarify their deeply-held values and set action goals in alignment with their values.
BEHAVIORAL	Cognitive Behavioral Therapy	Interventionists will provide psycho-education on the cognitive behavioral model of FCR and assist participants in changing unhelpful thinking patterns and maladaptive behaviors linked to FCR. Session topics will include FCR triggers, behavioral experiments to reduce FCR-perpetuating safety behaviors, and pleasant events scheduling. Interventionists will also provide evidence-based information on behaviors that may reduce recurrence risk (e.g., achieving a healthy weight, physical activity, cancer surveillance).

Timeline

• Start date: 2021-08-17
• Primary completion: 2024-07-09
• Completion: 2024-07-09
• First posted: 2022-05-06
• Last updated: 2024-12-04

Locations

1 site across 1 country: United States