Facilitating Adaptive Coping With Fear of Recurrence Among Breast Cancer Survivors

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.

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

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).

Sponsors & Collaborators

• Indiana University Health

  collaborator OTHER

• Eskenazi Health

  collaborator OTHER

• National Cancer Institute (NCI)

  collaborator NIH

• Indiana University

  lead OTHER

Principal Investigators

• Shelley A Johns, PsyD · Indiana University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-08-17

Primary Completion

2024-07-09

Completion

2024-07-09

Countries

• United States

Study Locations