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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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 con
• Поведенческое 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 ther

Первичные конечные точки

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

Вторичные конечные точки (3)

• Change in Neuroendocrine Regulation measured by Composite Stress Biomarkers [Срок оценки: Baseline, 6 months, 12 months]
• Change in Mental Health measured by Composite Depression Severity [Срок оценки: Baseline, 6 months, 12 months, 24 months]
• Change in Quality of Life measured by Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire [Срок оценки: Baseline, 6 months, 12 months, 24 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• University of Miami — Coral Gables

Идентификаторы

NCT: NCT07502352 · 20250766 · 1R01CA296071-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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