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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Remotely Delivered Cognitive Behavioral Stress Management Intervention (R-CBSM); Behavioral: Standard of Care Survivorship Care Planning

• Study Type: Interventional
• Enrollment (Estimated): 192
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dolores Perdomo, Ph.D; Phone Number: (305) 284-2220; Email: Dperdomo@miami.edu
• Study Contact Backup: Name: Dolores Perdomo

Study Locations

• United States
  • Florida
    • Coral Gables, Florida, United States, 33146
      • University of Miami
      • Contact: Dolores Perdomo, Ph.D; Phone Number: (305) 284-2220; Email: Dperdomo@miami.edu
      • Principal Investigator: Michael Antoni, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Psychological Adaptation measured by Cancer-Specific Distress (IES-Intrusion)	Cancer-specific intrusive distress will be measured using the 7-item Intrusion subscale of the Impact of Event Scale (IES). Each item is scored 0 ("not at all"), 1 ("rarely"), 3 ("sometimes"), or 5 ("often"), yielding a total score range of 0-35. Scores reflect the frequency of intrusive, cancer-related thoughts over the past 7 days. Higher scores indicate greater intrusive distress, and lower scores indicate fewer intrusive thoughts and better psychological adaptation. Change scores will be calculated as slope of change over 3 time points (baseline, 6months, and 12 months). Negative slops indicate improvement (reduced intrusive distress), and positive values indicate worsening. Change scores (slopes) will be compared between the R-CBSM+SCP and SCP-only arms to evaluate whether the combined intervention produces greater improvement over 6 and 12 months.	Baseline, 6 months, 12 months
Change in Immune Cell Senescence measured by Lymphocyte Metabolic Function	Change in immune cell senescence will be measured using latent construct composite of B- and T-lymphocyte metabolic indicators (ATP production, maximum respiration, and spare respiratory capacity). A composite score will be created from ATP production, maximum respiration, and spare respiratory capacity to index lymphocyte hyper-metabolism, a marker of cancer-accelerated aging. Higher composite values indicate greater immune senescence. Composite change scores (slope of change over the 4 time points) will be compared between study arms, R-CBSM+SCP and SCP only, over 6- and 12-months Increases indicate worsening immune senescence while decrease indicate lessening immune senescence.	Baseline, 6 months, 12 months, 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Neuroendocrine Regulation measured by Composite Stress Biomarkers	Change in neuroendocrine regulation assessed using a latent construct composite of 24-hour salivary cortisol area-under-the-curve (AUC), 24-hour salivary cortisol diurnal slope, and 4-day average heart rate variability (HRV). A standardized composite score will be created from cortisol AUC, cortisol diurnal slope, and 4-day average HRV to index neuroendocrine stress regulation. Increases in any of these indicators is associated with increased stress and greater neuroendocrine dysregulation. Change scores (slope of change over the 3 time points) will be compared between study arms. Increases in slope indicate worsening neuroendocrine dysregulation/stress while slope decreases indicate lessening neuroendocrine dysregulation/stress.	Baseline, 6 months, 12 months
Change in Mental Health measured by Composite Depression Severity	Change in depression severity will be measured using a latent construct composite of self-report and clinician-rated measures of depression: the Center for Epidemiologic Studies Depression Scale (CES-D), the Hamilton Rating Scale for Depression (HRSD), and depressive diagnoses from the Structured Clinical Interview for DSM-5 (SCID-5). A standardized composite score (e.g. Z score) will be created from CES-D total scores, HRSD clinician-rated severity scores, and SCID-5 depressive episode diagnoses to index overall depression severity. Higher composite values indicate greater depressive symptom burden. Change scores (slope of change over the 4 time points) will be compared between study arms. Increases over time indicate worsening depression while decreases indicate lowering of depression over time.	Baseline, 6 months, 12 months, 24 months
Change in Quality of Life measured by Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire	Change in quality of life will be measured using the patient-reported Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire. Quality of life will be measured using the FACT-B, a validated self-report questionnaire assessing physical, social, emotional, functional well-being, and breast cancer-specific concerns. Higher total scores indicate better quality of life. Score Range is 0-148 (higher scores reflect better quality of life). Change scores in total quality of life (slope of change over the 4 time points) will be compared between study arms. Therefore, increases in the slope indicate increasing quality of life while decreases indicate worsening quality of life over time.	Baseline, 6 months, 12 months, 24 months

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Michael Antoni, Ph.D, University of Miami

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029

Study Registration Dates

• First Submitted: March 25, 2026
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 31, 2026

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Breast Cancer Survivors
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 20250766; 1R01CA296071-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No