Feasibility of a weight loss intervention among female cancer survivors in SWOG

SWOG 中女性癌症幸存者减肥干预的可行性

基本信息

批准号：
8734511
负责人：
Heather Greenlee
金额：
$ 7.82万
依托单位：
COLUMBIA UNIVERSITY HEALTH SCIENCES
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-07-01 至 2016-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8734511
关键词：
Adherence Aerobic Exercise Aftercare Anxiety Behavioral Bioavailable Biological Markers Body Composition Body Size Body Weight Body Weight decreased Body fat Body mass index Breast Caloric Restriction Cancer Patient Cancer Survivor Cancer Survivorship Cardiovascular Diseases Cholesterol Clinical Trials Colorectal Colorectal Cancer Communities Community Clinical Oncology Program Counseling Country DEXA Data Diagnosis Diet Dietary Practices Dietary intake Disease-Free Survival Dose Educational Intervention Energy Intake Enrollment Estradiol Exercise Fasting Fatigue Fatty acid glycerol esters Feasibility Studies Female Female Breast Carcinoma Female breast Fitness Centers Goals Hemoglobin High Density Lipoproteins Hormonal Hospitals Incidence Institution Insulin Intake Intervention Length Location Low-Density Lipoproteins Manuals Measures Mental Depression Metabolic Metabolic Diseases Metabolic Marker Minority Mission Obesity Obesity associated disease Observational Study Outcome Overweight Participant Pattern Phase Phase III Clinical Trials Physical activity Pilot Projects Population Population Heterogeneity Quality of life Records Recruitment Activity Reducing diet Research Infrastructure Risk Site Southwest Oncology Group Survivors Telephone Testing Testosterone Time Treatment Efficacy Triglycerides Weight Weight maintenance regimen Woman Work adiponectin base cancer recurrence cancer risk design effective intervention efficacy testing fasting glucose fitness fruits and vegetables improved malignant breast neoplasm patient population phase 2 study phase 3 study programs saturated fat secondary outcome sedentary socioeconomics tumor waist circumference weight loss intervention

项目摘要

DESCRIPTION (provided by applicant): An estimated 60% of CA survivors are overweight/obese and sedentary. Observational studies have shown that lower BMI after diagnosis is associated with better breast and colorectal cancer survival. Clinical trials have yet to assess whether weight loss after diagnosis causes improved survival. Two substantial challenges exist to conducting large phase III studies of behavioral changes in cancer survivors: 1) rapid accrual of cancer patients who are geographically and socioeconomically diverse, and 2) access to an effective intervention that is transferable and sustainable in the real-world setting. The purpose of this proposed phase II pilot study is to assess the feasibility of conducting a weight loss intervention for breast and colorectal cancer survivors in the Southwest Oncology Group (SWOG). The study will use the Curves weight loss program, which combines circuit-based exercise with a high fruit/vegetable and low-fat calorie-reduced diet, and is widely available at over 5,000 Curves facilities across the US. Participants will receive an individualized weight loss goal and standardized support to reach their goal, including a 12-month membership to Curves fitness facility, a pedometer to track daily activity, and the Curves diet program via a manual and an on-line meal planning/dietary intake tracking program. The program will be supplemented with telephone behavioral counseling to increase education, intervention adherence and study retention. A total of 50 cancer survivors will be enrolled (25 breast and 25 colorectal cancer survivors) who are 6 months to 2 years post-treatment. Participants will be recruited using the rapid-accrual capabilities of SWOG. Minority cancer survivors will be targeted for recruitment at 26%. The primary aims of the study are 1) to determine the feasibility of a community-based combined physical activity and dietary change weight loss intervention in overweight and sedentary female breast and colorectal cancer survivors recruited via SWOG based on study accrual, intervention adherence, and study retention, and 2) to estimate the effect size of the intervention on weight loss. Secondary aims will assess changes in 1) anthropometric measures, 2) physical activity, 3) dietary patterns, 4) metabolic and hormonal biomarkers, and 5) quality of life, and will assess 6) the ability to enroll and retain a diverse patient population, and 7) the availability and acceptability of Curves. If this proposed intervention demonstrates feasibility and e5% weight loss, study results will be used to design a large phase III study to examine the effects of the Curves program on short- and long-term weight loss among overweight/obese female cancer survivors recruited via SWOG; secondary outcomes will examine the association between weight loss and disease-free survival. This study aligns with the mission of the NCI and the Office of Cancer Survivorship, which is to enhance the quality and length of survival of breast and colorectal cancer survivors.

描述（由申请人提供）：估计有60％的CA幸存者超重/肥胖和久坐。观察性研究表明，诊断后的BMI较低与更好的乳腺癌和结直肠癌的存活有关。临床试验尚未评估诊断后的体重减轻是否会提高生存率。对癌症幸存者的行为变化进行大量研究的大量研究存在两个重大挑战：1）在地理和社会经济上多样的癌症患者的快速应计，以及2）获得在现实世界中可转移和可持续的有效干预措施。这项拟议的II期试点研究的目的是评估西南肿瘤学组（SWOG）对乳腺癌和结直肠癌幸存者进行减肥干预的可行性。该研究将使用曲线减肥计划，该计划将基于电路的运动与高水果/蔬菜和低脂卡路里饮食相结合，并且在美国的5,000多个曲线设施中广泛使用。参与者将获得个性化的减肥目标和标准化的支持，以实现其目标，包括曲线健身设施的12个月会员资格，跟踪日常活动的计步器以及通过手动和在线进餐计划/饮食进餐/饮食进餐跟踪计划的曲线饮食计划。该计划将补充电话行为咨询，以增加教育，干预依从性和研究保留。治疗后6个月至2年的总共将招募50名癌症幸存者（25个乳腺癌和25个结直肠癌幸存者）。参与者将使用SWOG的快速性能招募。少数族裔癌症幸存者将被目标招募26％。该研究的主要目的是1）确定基于研究的应计，干预依从性和研究保留的超重和久坐的女性乳腺癌和结直肠癌幸存者在超重和久坐的女性乳腺癌和结直肠癌幸存者中的可行性和久坐的女性乳腺癌和结直肠癌幸存者的可行性，以及2），以估计减肥的影响大小。次要目的将评估1）人体测量指标的变化，2）体育活动，3）饮食模式，4）代谢和激素生物标志物和5）生活质量，并评估6）能够注册和保留多样化的患者人群，以及7）7）曲线的可用性和可接受性。如果该提出的干预措施表现出可行性和E5％的体重减轻，则研究结果将用于设计大型III期研究，以检查曲线计划对通过Swog招募的超重/肥胖女性癌症幸存者中短期和长期体重减轻的影响；次要结果将检查体重减轻与无疾病生存之间的关联。这项研究与NCI的任务和癌症生存办公室的任务保持一致，这是为了提高乳腺癌和大肠癌幸存者的生存质量和长度。