The Women In Steady Exercise Research (WISER) Survivor Trial & Cost of Illness and Cost Effectiveness of Alternative Management Strategies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Percent interlimb difference, change over 12 months.
研究概览
简要总结
WISER Survivor is a one year weight loss and exercise study for sedentary breast cancer survivors who are overweight or obese with breast cancer related lymphedema. There will be four groups in this trial: exercise only, weight loss only, exercise and weight-loss combined, and a control group. The primary purpose of this study is to test the effects of these interventions on clinical lymphedema outcomes. Secondary outcomes include weight loss, breast cancer related biomarkers, and quality of life. To the extent that funding will be available, participants will be followed long term to examine effects on recurrence and mortality.
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
- Single (Outcomes Assessor)
盲法说明
All participants asked at the start of each measurement encounter not to inform measurement staff of their randomization group status. All measurement staff asked to guess group status at end of each measurement encounter. Patterns of responses beyond chance result in corrective action to improve masking (e.g.; requests from PI for participants to mask group status)
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •breast cancer survivor
- •overweight or obese (BMI of 25 or greater)
- •must have breast cancer related lymphedema
- •at least 6 months post-treatment (e.g. surgery, chemotherapy, or radiotherapy) but there will be no upper limit on time elapsed from diagnosis
- •the eligible age range will have no lower limit.
- •currently free of cancer
排除标准
- •medical conditions or medications that would prohibit participation in an exercise program or would negatively impact our ability to test our primary aims
- •inability to walk for 6 minutes unaided
- •extremely obese (body mass index greater or equal to 50 kg/m2)
- •plans for additional (e.g. curative or reconstructive) surgery during the study period
- •self-report of weight-lifting within the past year
- •already engaging in 3 or more times weekly aerobic activity of moderate intensity
- •planning to move away from the area over the next year
- •current use of weight loss medication (OTC or prescription)
- •self-report of alcohol or substance abuse within the past 12 months, including at-risk drinking (current consumption of more than 14 alcoholic drinks per week)
- •weight loss of greater than 10 % in the past 3 months
- •history of bariatric surgery
- •women who are pregnant
研究组 & 干预措施
Lymphedema Care Only
All 4 groups receive lymphedema care as follows:
- 2 custom fitted compression garments (baseline and 6 months)
- evaluations for flare-ups at request (and at each measurement time point)
- lymphedema treatment by a certified lymphatic therapist upon detection of a flare-up, paid for by the study. No limit was placed on number of sessions.
Exercise only
The Exercise Intervention combines 60-90 minute twice-weekly supervised weight-lifting sessions with 180 minutes of weekly aerobic exercise. Women will be trained by certified fitness professionals in both the weight-lifting intervention and in safely increasing their aerobic exercise activity over 6 weekly sessions, and then monitored through phone contact, and monthly in-person sessions. All exercise participants will be provided with 'Power Blocks' which are adjustable dumbbells with which they can increase resistance in 1-2 pound increments from 1-21 pounds. All weight training will be done in their homes except for the first 6 weekly session and monthly check-in sessions. Exercise only group members also received the Lymphedema care intervention described above.
干预措施: Exercise Intervention (Behavioral)
Weight loss only
The Weight Loss Intervention begins with a 24 week intensive phase that includes weekly meetings and provision of all meals and snacks from a commercial manufacturer (NutriSystem®, Inc., Fort Washington, PA). Daily caloric intake will be strictly controlled during this first 24 weeks at 1200-1500 calories per day. Participants will be guided to stay at the same number of calories per day until reaching goal weight, followed by a gradual increase in caloric intake (of approximately 500 calories/d) to maintain their weight throughout the remainder of the intervention. The treatment groups will be led by registered dietitians and will receive ongoing supervision via telephone and email contact. Weight loss only group members also received the Lymphedema care intervention described above.
干预措施: Weight Loss Intervention (Behavioral)
Exercise and Weight loss combined
Participants in this group will receive a combination of the supervised twice-weekly weight training sessions and the weight loss program. Combined group members also received the Lymphedema care intervention described above.
干预措施: Exercise Intervention (Behavioral)
Exercise and Weight loss combined
Participants in this group will receive a combination of the supervised twice-weekly weight training sessions and the weight loss program. Combined group members also received the Lymphedema care intervention described above.
干预措施: Weight Loss Intervention (Behavioral)
结局指标
主要结局
Percent interlimb difference, change over 12 months.
时间窗: Baseline and 12 months
Arm volumes for affected and unaffected limbs will be measured by perometry and the % difference will be determined at baseline and 12 months. the absolute percentage point difference of differences (% interlimb difference at 12 months minus % interlimb difference at baseline) will be the primary outcome
次要结局
- Clinical Evaluation Score for Lymphedema(Baseline and 12 months)
- Clinical Lymphedema Events(Data collected over the 12 month follow-up, with events collected as reported)
- Weight loss(Baseline and 12 months)
- Biomarkers - Sex Hormone Binding Globulin(baseline and 12 months)
- F2-isoprostanes(baseline and 12 months)
- insulin like growth factor one(baseline and 12 months)
- Leptin(baseline and 12 months)
- Biomarkers: Testosterone(baseline and 12 months)
- Insulin(baseline and 12 months)
- body image and relationship survey(baseline and 12 months)
- Norman Lymphedema Survey(Baseline and 12 months)
- Biomarkers: Estradiol(baseline and 12 months)
- Adiponectin(baseline and 12 months)
- Glucose(baseline and 12 months)
- insulin like growth factor binding protein three(baseline and 12 months)
- Upper limb lymphedema twenty seven(baseline and 12 months)
- Inflammation: Interleukin six(baseline and 12 months)
- Inflammation: C reactive protein(baseline and 12 months)