Feasibility of the NEXT Steps Weight Loss Intervention +/- Resistance Training for Endometrial Cancer Survivors: Effect on Lean Mass & Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Feasibility of Two Home-Based Weight Loss Interventions for Endometrial Cancer Survivors
研究概览
简要总结
The goal of this research study is to learn if a home-based physical activity program is feasible and can help endometrial cancer survivors lose weight.
详细描述
Baseline Visit:
If participant is found to be eligible to take part in this study, an accelerometer will be mailed to them. An accelerometer is a small device that records participant's activity levels that participant wears on their waist during the day. Participant will wear this accelerometer for 7 days before their baseline visit. Participant will bring the accelerometer with them to the baseline visit.
Participant will also complete 8 questionnaires about their demographic information (such as their age, race, sex, and so on) / health and treatment history, current physical activity, quality of life, how well they function physically, sexual function, fatigue, body image, and safety as well as a brief survey about their exercise and nutrition preferences. It should take about 2 hours to complete the questionnaires and brief survey.
Participant will also complete 3 questionnaires online about what they ate in the last 24 hours. Two (2) will be completed during weekdays and the other on a weekend day. They should take about 45 minutes to complete. The link to the questionnaires will be emailed to participant.
At the baseline visit at MD Anderson:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Diagnosed with Stage I-II endometrial cancer
- •Six to 36 months post treatment
- •Body mass index (BMI) 30-<45 kg/m2
- •Age of at least 18 years
- •Access to a telephone for coaching sessions and access to a computer, smartphone, or tablet for syncing Fitbit devices
- •Can speak and read English
- •Can provide informed consent
- •Willing to travel to MD Anderson's main campus for 2 visits (baseline and 6 months post-baseline)
排除标准
- •Unmanaged lymphedema
- •Medical contraindications to home-based exercise or low-fat, high fruit and vegetable diet
- •Functional limitations requiring a walker/scooter/wheelchair for daily activities
- •Recurrent disease
- •Vigorous exercise > or = 60 min/week or moderate exercise > or = 150 min/week. If a combination of moderate and vigorous exercise are preformed, the minutes of moderate exercise/week plus 2 x minutes of vigorous exercise/week > or = 150 min/week.
- •Resistance training on > or = 2 days/week accounting for more than 30 minutes of strength training per week
- •Enrollment in a structured weight loss program in the past 6 months
研究组 & 干预措施
NEXT-Steps- Aerobic Exercise (NS-A)
Participant wears an accelerometer for 7 days before baseline visit. Six questionnaires completed regarding quality of life and diet. Fitness test given covering various physical activities at baseline and at 6 month visit.
Participants placed into an exercise plan focused on physical activity only. Physical activity guidelines workbook distributed along with activity monitor. Participants receive phone calls and text messages for support in reaching exercise and diet goals.
Questionnaires completed at 3 and 6 months regarding quality of life, diet, physical activity, etc.
干预措施: Accelerometer (Device)
NEXT-Steps- Aerobic Exercise and Resistance Training (NS-ART)
Participant wears an accelerometer for 7 days before baseline visit. Six questionnaires completed regarding quality of life and diet. Fitness test given covering various physical activities at baseline and at 6 month visit.
Participants placed into an exercise plan focused on physical activity and resistance training. Physical activity guidelines workbook distributed along with activity monitor. Participants receive phone calls and text messages for support in reaching exercise and diet goals.
Participants receive resistance bands to perform resistance exercises. Exercise handouts and an iPad mini with training videos used to video chat with a research team member.
Questionnaires completed at 3 and 6 months regarding quality of life, diet, physical activity, etc.
干预措施: Accelerometer (Device)
NEXT-Steps- Aerobic Exercise and Resistance Training (NS-ART)
Participant wears an accelerometer for 7 days before baseline visit. Six questionnaires completed regarding quality of life and diet. Fitness test given covering various physical activities at baseline and at 6 month visit.
Participants placed into an exercise plan focused on physical activity and resistance training. Physical activity guidelines workbook distributed along with activity monitor. Participants receive phone calls and text messages for support in reaching exercise and diet goals.
Participants receive resistance bands to perform resistance exercises. Exercise handouts and an iPad mini with training videos used to video chat with a research team member.
Questionnaires completed at 3 and 6 months regarding quality of life, diet, physical activity, etc.
干预措施: Questionnaires (Behavioral)
NEXT-Steps- Aerobic Exercise and Resistance Training (NS-ART)
Participant wears an accelerometer for 7 days before baseline visit. Six questionnaires completed regarding quality of life and diet. Fitness test given covering various physical activities at baseline and at 6 month visit.
Participants placed into an exercise plan focused on physical activity and resistance training. Physical activity guidelines workbook distributed along with activity monitor. Participants receive phone calls and text messages for support in reaching exercise and diet goals.
Participants receive resistance bands to perform resistance exercises. Exercise handouts and an iPad mini with training videos used to video chat with a research team member.
Questionnaires completed at 3 and 6 months regarding quality of life, diet, physical activity, etc.
干预措施: Fitness Test (Behavioral)
NEXT-Steps- Aerobic Exercise and Resistance Training (NS-ART)
Participant wears an accelerometer for 7 days before baseline visit. Six questionnaires completed regarding quality of life and diet. Fitness test given covering various physical activities at baseline and at 6 month visit.
Participants placed into an exercise plan focused on physical activity and resistance training. Physical activity guidelines workbook distributed along with activity monitor. Participants receive phone calls and text messages for support in reaching exercise and diet goals.
Participants receive resistance bands to perform resistance exercises. Exercise handouts and an iPad mini with training videos used to video chat with a research team member.
Questionnaires completed at 3 and 6 months regarding quality of life, diet, physical activity, etc.
干预措施: Resistance Training (Behavioral)
NEXT-Steps- Aerobic Exercise and Resistance Training (NS-ART)
Participant wears an accelerometer for 7 days before baseline visit. Six questionnaires completed regarding quality of life and diet. Fitness test given covering various physical activities at baseline and at 6 month visit.
Participants placed into an exercise plan focused on physical activity and resistance training. Physical activity guidelines workbook distributed along with activity monitor. Participants receive phone calls and text messages for support in reaching exercise and diet goals.
Participants receive resistance bands to perform resistance exercises. Exercise handouts and an iPad mini with training videos used to video chat with a research team member.
Questionnaires completed at 3 and 6 months regarding quality of life, diet, physical activity, etc.
干预措施: Telephone Coaching/Phone Calls (Behavioral)
NEXT-Steps- Aerobic Exercise and Resistance Training (NS-ART)
Participant wears an accelerometer for 7 days before baseline visit. Six questionnaires completed regarding quality of life and diet. Fitness test given covering various physical activities at baseline and at 6 month visit.
Participants placed into an exercise plan focused on physical activity and resistance training. Physical activity guidelines workbook distributed along with activity monitor. Participants receive phone calls and text messages for support in reaching exercise and diet goals.
Participants receive resistance bands to perform resistance exercises. Exercise handouts and an iPad mini with training videos used to video chat with a research team member.
Questionnaires completed at 3 and 6 months regarding quality of life, diet, physical activity, etc.
干预措施: Video Chat Sessions (Behavioral)
NEXT-Steps- Aerobic Exercise (NS-A)
Participant wears an accelerometer for 7 days before baseline visit. Six questionnaires completed regarding quality of life and diet. Fitness test given covering various physical activities at baseline and at 6 month visit.
Participants placed into an exercise plan focused on physical activity only. Physical activity guidelines workbook distributed along with activity monitor. Participants receive phone calls and text messages for support in reaching exercise and diet goals.
Questionnaires completed at 3 and 6 months regarding quality of life, diet, physical activity, etc.
干预措施: Questionnaires (Behavioral)
NEXT-Steps- Aerobic Exercise (NS-A)
Participant wears an accelerometer for 7 days before baseline visit. Six questionnaires completed regarding quality of life and diet. Fitness test given covering various physical activities at baseline and at 6 month visit.
Participants placed into an exercise plan focused on physical activity only. Physical activity guidelines workbook distributed along with activity monitor. Participants receive phone calls and text messages for support in reaching exercise and diet goals.
Questionnaires completed at 3 and 6 months regarding quality of life, diet, physical activity, etc.
干预措施: Fitness Test (Behavioral)
NEXT-Steps- Aerobic Exercise (NS-A)
Participant wears an accelerometer for 7 days before baseline visit. Six questionnaires completed regarding quality of life and diet. Fitness test given covering various physical activities at baseline and at 6 month visit.
Participants placed into an exercise plan focused on physical activity only. Physical activity guidelines workbook distributed along with activity monitor. Participants receive phone calls and text messages for support in reaching exercise and diet goals.
Questionnaires completed at 3 and 6 months regarding quality of life, diet, physical activity, etc.
干预措施: Aerobic Exercise (Behavioral)
NEXT-Steps- Aerobic Exercise (NS-A)
Participant wears an accelerometer for 7 days before baseline visit. Six questionnaires completed regarding quality of life and diet. Fitness test given covering various physical activities at baseline and at 6 month visit.
Participants placed into an exercise plan focused on physical activity only. Physical activity guidelines workbook distributed along with activity monitor. Participants receive phone calls and text messages for support in reaching exercise and diet goals.
Questionnaires completed at 3 and 6 months regarding quality of life, diet, physical activity, etc.
干预措施: Telephone Coaching/Phone Calls (Behavioral)
Standard Care Control Group (CG)
Participant wears an accelerometer for 7 days before baseline visit. Six questionnaires completed regarding quality of life and diet. Fitness test given covering various physical activities at baseline and at 6 month visit.
Participants receive standard of care consisting of phone calls asking about their health and self-help materials.
Questionnaires completed at 3 and 6 months regarding quality of life, diet, physical activity, etc.
干预措施: Accelerometer (Device)
Standard Care Control Group (CG)
Participant wears an accelerometer for 7 days before baseline visit. Six questionnaires completed regarding quality of life and diet. Fitness test given covering various physical activities at baseline and at 6 month visit.
Participants receive standard of care consisting of phone calls asking about their health and self-help materials.
Questionnaires completed at 3 and 6 months regarding quality of life, diet, physical activity, etc.
干预措施: Questionnaires (Behavioral)
Standard Care Control Group (CG)
Participant wears an accelerometer for 7 days before baseline visit. Six questionnaires completed regarding quality of life and diet. Fitness test given covering various physical activities at baseline and at 6 month visit.
Participants receive standard of care consisting of phone calls asking about their health and self-help materials.
Questionnaires completed at 3 and 6 months regarding quality of life, diet, physical activity, etc.
干预措施: Fitness Test (Behavioral)
Standard Care Control Group (CG)
Participant wears an accelerometer for 7 days before baseline visit. Six questionnaires completed regarding quality of life and diet. Fitness test given covering various physical activities at baseline and at 6 month visit.
Participants receive standard of care consisting of phone calls asking about their health and self-help materials.
Questionnaires completed at 3 and 6 months regarding quality of life, diet, physical activity, etc.
干预措施: Telephone Coaching/Phone Calls (Behavioral)
结局指标
主要结局
Feasibility of Two Home-Based Weight Loss Interventions for Endometrial Cancer Survivors
时间窗: 6 months
Study considered feasible if consent rate is larger than 40%.
Feasibility of Two Home-Based Weight Loss Interventions for Endometrial Cancer Survivors
时间窗: 6 Months
Study considered feasible if retention rate is larger than 70%.
次要结局
- Changes in Lean Body Mass(6 months)