Mobile-Health Delivery of Lifestyle Interventions for Women With Breast Cancer Multicenter Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Assess the feasibility of delivering a mobile, standardized, comprehensive lifestyle program in women with BCa.
研究概览
简要总结
This clinical trial aims to develop a lifestyle program to improve clinical outcomes in women with breast cancer who do not have a healthy diet, regular exercise habits, or ways to manage their stress well. The program will include support and counseling in healthy eating, physical activity, stress management and mindfulness, learning sleep hygiene techniques, and behavioral counseling in addition to social support. Developing a lifestyle program may help improve quality of life and encourage healthy lifestyle choices among patients diagnosed with breast cancer.
详细描述
PRIMARY OBJECTIVE:
I. Assess the feasibility of delivering a mobile, standardized, comprehensive lifestyle program in women with breast cancer (BCa).
SECONDARY OBJECTIVES:
I. Determine whether the comprehensive lifestyle intervention program (CLIP) group has reduction in body mass index (BMI) and percent body fat and weight over time.
II. Determine whether the CLIP group has improved outcomes in anthropometric measures, dietary patterns, and fitness measures and patient-reported outcomes including quality of life (QOL), fatigue, sleep disturbances, mental health, social support, and mindfulness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with stage I-III BCa scheduled to undergo radiation therapy (RT) or within the first 12 months of having completed primary treatment (they do not need to have undergone RT)
- •Underwent chemotherapy and surgery
- •Able to read, write, and speak English
- •BMI of 25 or higher
- •18 years of age or older
- •Oriented to person, place, and time
- •Participants must meet at least two of the following criteria related to their lifestyle at the time of diagnosis:
- •Consume less than 3 servings of fruit and vegetable/day
- •Engage in less than 75 minutes of moderate/vigorous intensity activity per week, defined as anything that causes small increases in breathing or heart rate for a sustained amount of time (e.g., brisk walking, bicycling)
- •Engage in a mind-body practice less than 4 times a month
- •Access to internet connection
- •Access to a tablet, laptop or computer
- •Able to come to University of Texas (UT) MD Anderson or Wake Forest for blood collection
- •Able to perform light physical activity. if any medical issues exist or arise that may limit performing physical activity, a medical release will be required
排除标准
- •Have not completed chemotherapy; have a recurrent BCa diagnosis; another primary cancer diagnosis within past 5 years (not including non-melanoma skin cancers)
- •Any major thought disorder (e.g., schizophrenia, dementia)
- •Any major communication barriers that would preclude being able to complete the intervention (e.g., visually or hearing impaired)
- •Poorly or uncontrolled diabetes in the opinion of the physician(s)
- •Extreme mobility issues (e.g., unable to get in and out of a chair unassisted)
研究组 & 干预措施
GROUP I (CLIP)
Patients undergo 60 minute sessions of nutrition education for 12 weeks and behavioral intervention 26 weeks. Patients receive FitBit and undergo physical activity for 30-60 minutes 5 days a week (aerobic activity) and 2 days a week (resistance training).
干预措施: Questionnaire Administration (Other)
GROUP II (usual care)
Patients have access to all usual care supportive services.
干预措施: Best Practice (Other)
GROUP I (CLIP)
Patients undergo 60 minute sessions of nutrition education for 12 weeks and behavioral intervention 26 weeks. Patients receive FitBit and undergo physical activity for 30-60 minutes 5 days a week (aerobic activity) and 2 days a week (resistance training).
干预措施: Behavioral Intervention (Behavioral)
GROUP I (CLIP)
Patients undergo 60 minute sessions of nutrition education for 12 weeks and behavioral intervention 26 weeks. Patients receive FitBit and undergo physical activity for 30-60 minutes 5 days a week (aerobic activity) and 2 days a week (resistance training).
干预措施: FitBit (Device)
GROUP I (CLIP)
Patients undergo 60 minute sessions of nutrition education for 12 weeks and behavioral intervention 26 weeks. Patients receive FitBit and undergo physical activity for 30-60 minutes 5 days a week (aerobic activity) and 2 days a week (resistance training).
干预措施: Nutrition Education (Behavioral)
GROUP I (CLIP)
Patients undergo 60 minute sessions of nutrition education for 12 weeks and behavioral intervention 26 weeks. Patients receive FitBit and undergo physical activity for 30-60 minutes 5 days a week (aerobic activity) and 2 days a week (resistance training).
干预措施: Physical Activity (Other)
GROUP II (usual care)
Patients have access to all usual care supportive services.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Assess the feasibility of delivering a mobile, standardized, comprehensive lifestyle program in women with BCa.
时间窗: up to 9 months after study baseline
The feasibility criteria will include consent rate (how many patients are consented in a period of time), adherence rate ( how many patients adhere to the program and finish it), and study retention rate ( how many patients that are consented stay with the program until the end/ low number of participants withdrawing from the study after consent).
次要结局
未报告次要终点