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

Part of paid clinical trials in Coral Gables, Florida.

Sponsor
University of Miami
Study ID
NCT07502352
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Remotely Delivered Cognitive Behavioral Stress Management Intervention (R-CBSM) — BEHAVIORAL
    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.
  • Standard of Care Survivorship Care Planning — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Mar 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
192 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: R-CBSM+Survivorship Care Planning (SCP)
    Subjects in this group will receive 10 weeks of group R-CBSM intervention convened by a broadband connection for approximately 75 - 90 minutes at a mutually convenient time plus a standard of care survivorship care planning.
  • Active Comparator: Standard of Care Survivorship Care Planning (SCP Only)
    Participants in this group will receive the standard of care survivorship care planning (SCP) only. Each participant will have a 30-minute orientation call to provide them with information on Survivorship Care Planning (SCP) and answer any questions they may have.

Primary Outcome Measure

Change in Psychological Adaptation measured by Cancer-Specific Distress (IES-Intrusion) [ Time Frame: Baseline, 6 months, 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiCoral GablesFlorida33146
Dolores Perdomo, Ph.D
[email protected]
(305) 284-2220
Michael Antoni, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Coral Gables, FL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Miami· Coral Gables, FL

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