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 60% 的 CA 幸存者超重/肥胖且久坐。观察性研究表明，诊断后较低的体重指数与乳腺癌和结直肠癌更好的生存率相关。临床试验尚未评估诊断后体重减轻是否会提高生存率。对癌症幸存者行为变化进行大型 III 期研究存在两个重大挑战：1）快速增加地理和社会经济多样化的癌症患者，2）获得在现实环境中可转移且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对西南肿瘤学组 (SWOG) 的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 Curves 减肥计划，该计划将基于循环的锻炼与高水果/蔬菜和低脂肪热量减少的饮食相结合，并在美国 5,000 多个 Curves 设施中广泛使用。参与者将获得个性化的减肥目标和实现目标的标准化支持，包括 Curves 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册和在线膳食计划/制定的 Curves 饮食计划/膳食摄入跟踪计划。该计划将辅以电话行为咨询，以提高教育、干预依从性和学习保留率。将总共招募 50 名治疗后 6 个月至 2 年的癌症幸存者（25 名乳腺癌幸存者和 25 名结直肠癌幸存者）。将利用 SWOG 的快速累积功能来招募参与者。少数族裔癌症幸存者的招募目标为 26%。该研究的主要目的是 1) 根据研究应计情况、干预依从性和研究，确定对通过 SWOG 招募的超重和久坐女性乳腺癌和结直肠癌幸存者进行基于社区的综合体力活动和饮食改变减肥干预的可行性保留率，2) 估计干预措施对减肥的效果大小。次要目标将评估 1) 人体测量指标、2) 体力活动、3) 饮食模式、4) 代谢和激素生物标志物以及 5) 生活质量的变化，并将评估 6) 招募和保留多样化患者群体的能力和 7) 曲线的可用性和可接受性。如果这项拟议的干预措施证明可行并且体重减轻了 5%，研究结果将用于设计一项大型 III 期研究，以检查 Curves 计划对通过招募的超重/肥胖女性癌症幸存者的短期和长期体重减轻的影响SWOG；次要结果将检查体重减轻和无病生存率之间的关联。这项研究符合 NCI 和癌症幸存者办公室的使命，即提高乳腺癌和结直肠癌幸存者的生存质量和延长生存时间。