TeleHealth Resistance Exercise Intervention to Preserve Dose Intensity and Vitality in Elder Breast Cancer Patients (THRIVE-65)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 270
- 试验地点
- 5
- 主要终点
- Received Dose Intensity (RDI)
研究概览
简要总结
This research is being done to assess whether an exercise intervention with protein intake support vs a health education and support program will make it easier for women age 65 or older who are receiving chemotherapy for breast cancer to receive all of their planned chemotherapy according to schedule and at the planned dose.
详细描述
The research study procedures include screening for eligibility. After participants are determined to be eligible and have signed consent, they will participate in a baseline visit to collect measurements (e.g., weight/height/waist measurements) and questionnaires, a memory test, functional movement and strength testing, and a physical activity assessment. After baseline measures are collected, participants will be randomized to either the THRIVE Exercise and Diet Intervention or the Heath Education and Support Program during chemotherapy. There is a follow up visit up to 4 weeks after the completion of chemotherapy to repeat measurements and questionnaires.
The duration of the study will be 10-26 weeks, depending on the type of chemotherapy participants are receiving.
The THRIVE Intervention will involve:
- Exercise: Participants in the THRIVE Intervention arm work with an exercise coach to participate in both muscle strengthening exercises and aerobic exercises. There is one in-person exercise session at the beginning of the study. The remainder of the exercise sessions are done twice weekly via telehealth throughout chemotherapy treatment.
- Protein intake support: Participants in the THRIVE Intervention will meet with a dietitian to make sure they are eating enough protein throughout their chemotherapy treatments. Participants will be asked to keep a daily protein checklist and share this with the exercise coach each week.
The Health Education Support Program will involve:
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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women age >=65
- •Diagnosed with stage I-III invasive breast cancer
- •BMI between 18-50 kg/m2
- •Scheduled to begin at least 10 weeks of neoadjuvant or adjuvant cytotoxic chemotherapy for curative intent
- •If enrolled in clinical chemotherapy drug trial, considered eligible if regimen includes an anthracycline or a taxane, unless the trial alters the chemotherapy agents/doses according to patient response (e.g.; I-SPY trials)
- •Self-reported ability to walk for 6 minutes and/or 2 blocks (with or without assistive device)
- •Ability to provide written informed consent.
- •Ability to understand, speak, and read English. This is because many of the study instruments used are not readily available in multiple languages. Additionally, site-based study staff, such as exercise physiologists, are not bilingual and not all sites have access to interpreters.
排除标准
- •Following a therapeutic diet for co-morbid disease where the THRIVE-65 diet would be contraindicated as assessed by the RD
- •Engaging in 2 or more sessions of strength training exercise per week over a period of at least 3 consecutive months over the past year
- •Engaging in aerobic activity at a level that includes competitive events (e.g., marathon, triathlon, running races) over the past year
- •Presence of medical conditions or medications that would prohibit participation in an exercise program
- •Current use of weight-loss medication
- •Documented history of alcohol or substance abuse within the past 12 months
- •History of dementia
研究组 & 干预措施
HEALTH EDUCATION AND SUPPORT CONTROL GROUP
The research study procedures include screening for eligibility and a baseline visit to collect measurements and questionnaires. After the baseline appointment, participants randomized into the Heath Education Support Program will receive a tablet from the study that is pre-loaded with material to help support them during chemotherapy. The tablet materials will include supportive care and resources that focus on movement (light stretching and gentle yoga), soothing music, meditation/mindfulness, and recipes/cooking demos. Participants in this arm will be asked to fill out questionnaires at the start of each chemotherapy cycle to indicate any side effects from chemotherapy and the amount of time they spend engaging with the tablet. At the end of participants' chemotherapy, they will be asked to complete end-of-study measures.
干预措施: Health Education Support Program (Behavioral)
THRIVE: EXERCISE INTERVENTION WITH PROTEIN INTAKE SUPPORT
The research study procedures include screening for eligibility and a baseline visit to collect measurements and questionnaires. After the baseline appointment, participants randomized into the THRIVE Exercise and Diet Intervention will work with a coach to gradually build exercise and stay active during chemotherapy treatment. Participants will work with an exercise coach to reach the muscle strengthening and aerobic exercise goals of the study. Participants will also consult with a dietician to ensure adequate protein intake during the study. Participants in this arm will be asked to fill out questionnaires at the start of each chemotherapy cycle to indicate any side effects from chemotherapy. At the end of participants' chemotherapy, they will be asked to complete end-of-study measures.
干预措施: THRIVE (Behavioral)
结局指标
主要结局
Received Dose Intensity (RDI)
时间窗: Baseline to 26 weeks
Review of electronic medical records to discern chemotherapy dose received versus prescribed.
次要结局
- Measure of hematologic chemotoxicity - Hematocrit(Baseline to 26 weeks)
- Measure of hematologic chemotoxicity- White blood cell count(Baseline to 26 weeks)
- Measure of hematologic chemotoxicity - Platelet count(Baseline to 26 weeks)
- Accelerometry(Baseline to 26 weeks)
- Morgenstern Physical Activity Questionnaire (PAQ-M)(Baseline to 26 weeks)
- Measure of hematologic chemotoxicity - Neutrophil count(Baseline to 26 weeks)
- MOS SF-36 Questionnaire(Baseline to 26 weeks)
- Strength(Baseline to 26 weeks)
- Anthropometric measure - weight(Baseline to 26 weeks)
- Patient-reported chemotoxicities(Baseline to 26 weeks)
- Pittsburgh Sleep Quality Index (PSQI)(Baseline to 26 weeks)
- Diet(Baseline to 26 weeks)
- Anthropometric measure - waist circumference(Baseline to 26 weeks)
- Anthropometric measure - height(Baseline to 26 weeks)
研究者
Jennifer A. Ligibel, MD
Principal Investigator
Dana-Farber Cancer Institute