Recruiting

R-CBSM

Sponsor:

University of Miami

Code:

NCT07502352

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 50+

Healthy Volunteers: Not accepted

Interventions

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

Standard of Care Survivorship Care Planning

Study Details

Brief 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.

Conditions

Breast Cancer

Study ID

NCT07502352

Start date

Jul, 2026

Status verified date

Jul, 2026

Completion date

Aug, 2029

Anticipated

Primary completion date

Aug, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 50+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 50 yrs or older
  • Speaks and reads English or Spanish at 6th grade level
  • Diagnosed and completed primary treatment for Stage I-III HR + estrogen/ progesterone + (ER/PR)
  • Human Epidermal Growth Factor Receptor 2 (Her2neu)- breast cancer 3 - 12 months prior
  • Post-menopausal (> 12 months since last menstrual cycle)
  • Elevated distress (Impact of Event Scale-intrusive thoughts \[IES-I\] > 14 or elevated distress based on assessment of PI
  • If prescribed anti-depressants or anxiolytics on similar regimen > 2 months.
  • Undergoing treatment with Adjuvant Endocrine Therapy (AET)
  • Participants may or may not have received chemotherapy or radiation during primary treatment

Exclusion Criteria:

  • Unable or unwilling to provide informed consent
  • Diagnosis with metastatic disease, HER2neu+ or Triple Negative breast cancer
  • Prior cancer diagnosis (with the exception of non-melanoma skin cancer) in the 2 years prior to the current breast cancer diagnosis
  • Active untreated major mental illness (e.g., schizophrenia, psychosis, bi-polar, substance abuse, panic disorder, PTSD diagnosis),
  • Acute or chronic co-morbid medical condition with known effects on the immune system (e.g., HIV infection, autoimmune diseases such as Lupus, Rheumatoid Arthritis, Acute or Chronic Hepatitis, and Multiple Sclerosis, Graves' Disease, Chronic Fatigue Syndrome, Fibromyalgia etc.). example: history of heart disease, e.g., past stroke, myocardial infarction (MI), or congestive heart failure are not exclusionary.
  • Significant cognitive impairment, <32 on the Telephone Interview for Cognitive Status (TICS)
  • Receipt of immunotherapy as part of treatment

Study Design

Enrollment

192 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

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.

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.

Primary outcome measure

  • Change in Psychological Adaptation measured by Cancer-Specific Distress (IES-Intrusion) [ Time Frame: Baseline, 6 months, 12 months ]
  • Change in Immune Cell Senescence measured by Lymphocyte Metabolic Function [ Time Frame: Baseline, 6 months, 12 months, 24 months ]

Central Contacts and Locations

Central contacts

Dolores Perdomo, Ph.D

(305) 284-2220Dperdomo@miami.edu

Locations

University of Miami

Recruiting

Coral Gables, Florida, United States, 33146

Contacts

Dolores Perdomo, Ph.D

(305) 284-2220Dperdomo@miami.edu

Principal Investigator:

Michael Antoni, PhD

More Information

Sponsor

University of Miami

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

Keywords

  • Breast Cancer Survivors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-07-10.