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NOT YET RECRUITING
NCT07502352
NA

Remotely-Delivered Cognitive Behavioral Stress Management for Breast Cancer (R-CBSM)

Sponsor: University of Miami

View on ClinicalTrials.gov

Summary

The purpose of this research study to find out if a program called Remotely-delivered Cognitive Behavioral Stress Management (R-CBSM) can help women with breast cancer in the period of survivorship after they have completed treatment. This is a group stress management program done from home using technology, like Zoom to conduct video calls to conduct group-based training in stress management techniques (e.g., relaxation, cognitive behavioral therapy, coping skills training) in a supportive environment. It is for women aged 50 or older who have finished their main breast cancer treatments (like surgery, radiation, or chemo) and are undergoing hormone treatment. This study is important because many breast cancer survivors still feel stress, even after treatment ends. Teaching stress management may help the body and mind work better and may slow down the effects of aging caused by cancer and stress.

Official title: Remotely-Delivered Cognitive Behavioral Stress Management Effects on Cancer Accelerated Aging in Older, Distressed Breast Cancer Survivors

Key Details

Gender

FEMALE

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

192

Start Date

2026-05

Completion Date

2029-08

Last Updated

2026-03-31

Healthy Volunteers

No

Conditions

Interventions

BEHAVIORAL

Remotely Delivered Cognitive Behavioral Stress Management Intervention (R-CBSM)

Participants will receive the remotely delivered "telehealth" Cognitive Behavioral Stress Management (CBSM) intervention, consisting of 10 weeks of structured group sessions. The program will include core CBSM components such as cognitive restructuring, relaxation training, coping skills development, and strategies for managing stress-related thoughts and behaviors. Sessions will be conducted via a secure broadband connection and will last approximately 75-90 minutes, scheduled at a mutually convenient time for group members. Prior to beginning the intervention, each participant will complete a 30-minute individual orientation call. This session will provide instructions on how to join and participate in the group meetings remotely using videoconferencing on a handheld device, laptop, desktop computer, or mobile phone. The orientation will also familiarize participants with the technology, group procedures, and expectations to ensure smooth engagement throughout the program.

BEHAVIORAL

Standard of Care Survivorship Care Planning

Participants will receive the Standard of Care Survivorship Care Planning that includes a 30-minute orientation call to provide them with information on Survivorship Care Planning (SCP) and answer any questions they may have. The SCP being used in the proposed study will use a prospective preparation of the treatment summary and care plan. The SCP is designed to facilitate access to resources provided by our cancer center's survivorship program (e.g., nutritional, exercise physiology, music therapists, acupuncture) which we will monitor for use. The SCP is based on templates for breast cancer survivorship employed at the Sylvester Comprehensive Cancer Center (SCCC) Breast Survivorship Program and includes access to cancer survivorship resources, which is the standard of care control condition.

Locations (1)

University of Miami

Coral Gables, Florida, United States