Remotely-Delivered Cognitive Behavioral Stress Management Effects on Cancer Accelerated Aging in Older, Distressed Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Change in Psychological Adaptation measured by Cancer-Specific Distress (IES-Intrusion)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Psychological Adaptation measured by Cancer-Specific Distress (IES-Intrusion)
时间窗: Baseline, 6 months, 12 months
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.
Change in Immune Cell Senescence measured by Lymphocyte Metabolic Function
时间窗: Baseline, 6 months, 12 months, 24 months
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.
次要结局
- 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)
研究者
Michael H. Antoni
Professor
University of Miami