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

University of Miami

Status: Enrolling

Conditions: Breast Cancer

Treatments: Behavioral: Standard of Care Survivorship Care Planning; Behavioral: Remotely Delivered Cognitive Behavioral Stress Management Intervention (R-CBSM)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07502352

20250766

1R01CA296071-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 192 estimated patients

Sex: Female

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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192 participants in 2 patient groups

R-CBSM+Survivorship Care Planning (SCP)

Experimental group

Description:

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.

Treatment:

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 group

Description:

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.

Treatment:

Behavioral: Standard of Care Survivorship Care Planning