رادار التجارب AI | ||
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حالة التجربة السريرية NCT05132296 لـ سرطان الثدي هي نشط (التجنيد مغلق). اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
مركز إم دي أندرسون للسرطان Mobile-Health Delivery of Lifestyle Interventions for Women With Breast Cancer
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.
OUTLINE: Patients are randomized into 1 of 2 groups.
GROUP I: 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).
GROUP II: Patients have access to all usual care supportive services.
Mobile-Health Delivery of Lifestyle Interventions for Women With Breast Cancer Multicenter Pilot Trial
- 2020-1190
- NCI-2021-08961 (معرف السجل) (CTRP (Clinical Trial Reporting Program))
- 2020-1190 (معرف آخر) (M D Anderson Cancer Center)
- UG1CA189824 (منحة/عقد NIH الأمريكي)
| مجموعة المشاركين/مجموعة | تَدَخُّل/علاج |
|---|---|
تجريبيةGROUP 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). | تدخل سلوكي Undergo behavioral counseling فيتبيت Receive FitBit التثقيف الغذائي Receive nutrition education النشاط البدني Undergo physical activity إدارة الاستبيان Ancillary studies |
مقارن نشطGROUP II (usual care) Patients have access to all usual care supportive services. | أفضل الممارسات Receive usual care supportive services إدارة الاستبيان Ancillary studies |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Assess the feasibility of delivering a mobile, standardized, comprehensive lifestyle program in women with BCa. | 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). | up to 9 months after study baseline |
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
- 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)
مركز إم دي أندرسون للسرطان 1128 تجارب سريرية نشطة للاستكشافالمعهد الوطني للسرطان3028 تجارب سريرية نشطة للاستكشافNorth Carolina
Texas