NCT01453452已完成不适用
S1008: Feasibility Study of a Physical Activity and Dietary Change Weight Loss Intervention In Breast and Colorectal Cancer Survivors, Phase II
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 58
- 主要终点
- Attendance of ≥ 2 Curves sessions/week for a minimum of 36 of the 52 weeks of intervention
研究概览
简要总结
RATIONALE: Physical activity, diet, and counseling may help breast and colorectal cancer survivors to lose weight and improve their quality of life.
PURPOSE: This phase II trial studies how well exercise, diet, and counseling work in improving physical activity and weight loss in overweight women who are breast and colorectal cancer survivors.
详细描述
OBJECTIVES:
Primary
- To determine the feasibility of a 12-month community-based combined physical activity and dietary change weight-loss intervention in overweight and sedentary female breast and colorectal cancer survivors recruited via the Southwest Oncology Group (SWOG).
- To estimate the effect size of the intervention on weight loss at 12 months.
Secondary
- To measure changes in anthropometric measures from baseline (body mass index [BMI], waist and hip circumference) at 6 and 12 months and body composition (% body fat as assessed by dual-energy X-ray absorptiometry [DXA] scan) at 12 months.
- To measure changes in minutes spent per week in moderate-to-vigorous aerobic activity from baseline using Curves attendance records and a 7-day physical activity assessment at 6 and 12 months.
- To measure changes from baseline to 6 and 12 months in dietary intake of carotenoids via serum carotenoid measures.
- To assess changes from baseline to 6 and 12 months in perceived benefit of dietary change, physical activity, and weight loss after a cancer diagnosis.
- To measure changes from baseline in metabolic and hormonal biomarkers associated with breast and colorectal cancer recurrence risk (fasting insulin, fasting glucose, hemoglobin A1C, bioavailable estradiol, free testosterone, and adiponectin) at 6 and 12 months.
- To assess changes from baseline in anxiety, depression, fatigue, sleep, satisfaction with social roles, pain, and physical function using the PROMISE-43 at 6 and 12 months.
- To assess baseline predictors (medical history, health behaviors, quality of life) of subjects who adhere to and complete the intervention.
- To assess the diversity of subjects who enroll and complete the intervention.
- To assess the availability and acceptability of the Curves fitness centers at 12 months.
- To explore changes in DNA methylation.
- To assess the intervention and study process via open-ended interviews with SWOG sites and Curves franchises.
- To measure changes in anthropometric measures and assess feasibility of extended follow-up at 24 and 36 months.
- To assess the safety of the Curves® fitness centers for this population by assessing self-reported changes in lymphedema and any injuries as measured at 6 and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 120 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Participants must be women with a previous diagnosis of stage I, II, or III invasive breast cancer or colorectal cancer
- •Participants must have no evidence of disease at the time of registration and no history of metastases (M0)
- •Participants must have a body mass index ≥ 25 kg/m^2 measured within 28 days of registration
- •Participants must be considered sedentary (defined as < 60 minutes of moderate to vigorous physical activity per week; moderate exercise defined as exercising to the point of sweating)
- •Participants must be willing to submit blood samples for biomarkers (insulin, glucose, HgbA1C, estradiol, and testosterone) and undergo DXA scans, and must be given the option to consent for specimen submission for banking and future translational medicine studies
- •Participants must be willing and able to attend a Curves fitness center at least 3 times per week for 12 months
- •PATIENT CHARACTERISTICS:
- •Participants must be post-menopausal, as defined by at least one of the following:
- •At least 12 months since the last menstrual period
- •Prior bilateral oophorectomy
- •Previous hysterectomy with one or both ovaries left in place (or previous hysterectomy in which documentation of bilateral oophorectomy is unavailable) AND follicle-stimulating hormone (FSH) values consistent with the institutional normal values for the post-menopausal state
- •If participant is under the age of 55, FSH levels must be obtained within 28 days prior to registration
- •Zubrod performance status of 0
- •Participants must have no abnormal changes on a regular (non-nuclear) cardiovascular exercise stress test (using a treadmill or bicycle) as measured by electrocardiogram (EKG)
- •EKG must be within institutional limits of normal
- •Results of previous cardiac exercise stress test may be used as long as it was done within 3 months prior to registration
- •Participants must not have evidence of uncontrolled hypertension
- •Participants with diabetes, pre-diabetes, and/or metabolic syndrome must have HgbA1C ≤ 8% within the past 28 days
- •Current use of diabetes medications is allowed
- •No other prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the participant has been disease-free for > 5 years
- •Participants must not be active smokers within past 90 days; active smoking is defined as any smoking, even a puff
- •Participants must have regular access to the internet in order to receive monthly nutrition-program newsletter e-mails and to complete study questionnaires online
- •Participants must be able to understand, speak, and read English
- •Participants must have a home phone or cell phone and agree to participate in the 14 (40-minute) behavioral counseling sessions and 9 (20-30-minute) telephone interviews
- •Participants must have a baseline physical exam and physician clearance (primary care provider, medical oncologist, or surgical oncologist) to participate in the weight loss and exercise prior to enrollment within 60 days of registration; copy of physician clearance document must be submitted
- •PRIOR CONCURRENT THERAPY:
- •Participants must be 90 days to 730 days post-surgery, chemotherapy, and radiation therapy
- •Current hormonal therapy is allowed among breast cancer participants
- •Other concurrent anti-cancer therapies, including Herceptin, are not allowed
- •Surgery is defined as any major surgical procedure (resection or reconstructive) that would preclude inclusion in the exercise program
- •If the participant has had a remedial surgical procedure (e.g., revision of reconstruction) or persistent complications from her original operation, approval will be obtained from the participant's surgeon prior to enrollment
- •Persistent complications may include, but are not limited to, prolonged wound healing, hernias, or ostomy prolapse
排除标准
- 未提供
研究组 & 干预措施
Exercise and Lifestyle counseling
Experimental
Patients will receive behavioral dietary intervention & counseling intervention by phone, exercise intervention at Curves(R) facility, and take a quality-of-life assessment online.
干预措施: behavioral dietary intervention (Behavioral)
Exercise and Lifestyle counseling
Experimental
Patients will receive behavioral dietary intervention & counseling intervention by phone, exercise intervention at Curves(R) facility, and take a quality-of-life assessment online.
干预措施: exercise intervention (Behavioral)
Exercise and Lifestyle counseling
Experimental
Patients will receive behavioral dietary intervention & counseling intervention by phone, exercise intervention at Curves(R) facility, and take a quality-of-life assessment online.
干预措施: counseling intervention (Other)
Exercise and Lifestyle counseling
Experimental
Patients will receive behavioral dietary intervention & counseling intervention by phone, exercise intervention at Curves(R) facility, and take a quality-of-life assessment online.
干预措施: quality-of-life assessment (Procedure)
结局指标
主要结局
Attendance of ≥ 2 Curves sessions/week for a minimum of 36 of the 52 weeks of intervention
时间窗: 1 year from registration
Increase in fruit and vegetable consumption by 1 full serving per day (not including iceberg lettuce, potatoes, or fruit juices) OR reduce caloric intake by 100 kcal/day
时间窗: 1 year from registration
次要结局
- Changes in anthropometric measures (weight, BMI, waist circumference, hip circumference)(1 year from registration)
- Changes in metabolic and hormonal biomarkers associated with breast and colorectal cancer-recurrence risk (fasting insulin, fasting glucose, hemoglobin A1C, bioavailable estradiol, free testosterone, and adiponectin)(3 years)
- Changes in body composition (% body fat as assessed by DXA scan at 12 months only)(1 year from registration)
- Changes in dietary intake patterns based on three separate 24-hour diet recalls(1 year from registration)
- Changes in minutes spent per week in moderate-to-vigorous intensity aerobic activity using Curves attendance records and a 7-day physical activity recall assessment(1 year from registration)
- Changes in anxiety, depression, fatigue, sleep, satisfaction with social roles, pain, and physical function as measured by the PROMIS-43(1 year from registration)
- DNA methylation patterns(3 years)
研究者
研究点 (58)
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