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

NCT07502352 | Not Yet Recruiting DMC

• 2 other identifiers: 202507661R01CA296071-01A1
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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

Keywords

Breast Cancer Survivors

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change in Neuroendocrine Regulation measured by Composite Stress Biomarkers

  Baseline, 6 months, 12 months

• Change in Mental Health measured by Composite Depression Severity

  Baseline, 6 months, 12 months, 24 months

• Change in Quality of Life measured by Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire

  Baseline, 6 months, 12 months, 24 months

Study Arms (2)

R-CBSM+Survivorship Care Planning (SCP)

EXPERIMENTAL

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); Behavioral: Standard of Care Survivorship Care Planning

Standard of Care Survivorship Care Planning (SCP Only)

ACTIVE COMPARATOR

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

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.

R-CBSM+Survivorship Care Planning (SCP)

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.

R-CBSM+Survivorship Care Planning (SCP); Standard of Care Survivorship Care Planning (SCP Only)

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: Females with Breast Cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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),
• Significant cognitive impairment, \<32 on the Telephone Interview for Cognitive Status (TICS)
• Receipt of immunotherapy as part of treatment

Sponsors & Collaborators

• University of Miami: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Miami

Coral Gables, Florida, 33146, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Michael Antoni, Ph.D

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dolores Perdomo, Ph.D

CONTACT

(305) 284-2220; Dperdomo@miami.edu

Dolores Perdomo

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: March 31, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)