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

描述(由申请人提供)：估计60%的CA幸存者超重/肥胖并久坐不动。观察性研究表明，确诊后较低的BMI与较好的乳腺癌和结直肠癌存活率相关。临床试验尚未评估确诊后的体重减轻是否会提高存活率。对癌症幸存者的行为变化进行大型第三阶段研究存在两个重大挑战：1)地理和社会经济多样性的癌症患者的快速增长；2)在现实世界中可转移和可持续的有效干预措施的获得。这项拟议的第二阶段试点研究的目的是评估对西南肿瘤组(SWOG)的乳腺癌和结直肠癌幸存者进行减肥干预的可行性。这项研究将使用Curves减肥计划，该计划将基于循环的锻炼与高水果/蔬菜和低脂肪卡路里减少饮食相结合，在全美5000多家Curves减肥机构广泛提供。参与者将获得个性化的减肥目标和标准化的支持，以实现他们的目标，包括Curves健身设施12个月的会员资格，用于跟踪日常活动的计步器，以及通过手册和在线膳食计划/饮食摄入量跟踪计划的Curves饮食计划。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。共有50名癌症幸存者(25名乳腺癌幸存者和25名结直肠癌幸存者)将在治疗后6个月至2年内入选。参与者将利用SWOG的快速积累能力进行招募。少数癌症幸存者将以26%的比例被招募。这项研究的主要目的是：1)根据研究收益、干预依从性和研究保留率，确定在通过SWOG招募的超重和久坐的女性乳腺癌和结直肠癌患者中，以社区为基础的体力活动和饮食变化相结合的减肥干预的可行性，以及2)估计干预对减肥的影响程度。二级目标将评估1)人体测量指标、2)体力活动、3)饮食模式、4)代谢和荷尔蒙生物标志物以及5)生活质量的变化，并将评估6)登记和保留多样化患者群体的能力，以及7)Curves的可用性和可接受性。如果这项拟议的干预措施证明了可行性，体重减轻了5%，研究结果将被用来设计一项大型的第三阶段研究，以检验Curves计划对通过SWOG招募的超重/肥胖女性癌症幸存者的短期和长期减肥效果；二次结果将检验减肥和无病生存之间的联系。这项研究与NCI和癌症生存办公室的使命一致，即提高乳腺癌和结直肠癌幸存者的生存质量和生存时间。 公共卫生相关性：癌症幸存者的人数在不断增加，癌症幸存者中超重/肥胖的发生率也在不断上升。观察性研究表明，诊断后较低的BMI与较好的乳房和结直肠存活率相关，并假设诊断后体重减轻将提高无病存活率。这项第二阶段的试点研究将测试在NCI西南肿瘤组使用Curves减肥计划结合电话管理的行为咨询进行减肥干预的可行性。

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. PUBLIC HEALTH RELEVANCE: There is a growing population of cancer survivors, and a growing incidence of overweight/obesity among cancer survivors. Observational studies have shown that lower BMI post-diagnosis is associated with better breast and colorectal survival and it is hypothesized that weight loss post-diagnosis will improve disease-free survival. This phase II pilot study will test the feasibility of conducting a weight loss intervention in the NCI Southwest Oncology Group using the Curves weight loss program in combination with telephone- administered behavioral counseling.