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/肥胖和久坐。观察性研究表明，诊断后较低的BMI与乳腺癌和结直肠癌的生存率相关。临床试验尚未评估诊断后体重减轻是否会提高生存率。开展癌症幸存者行为变化的大型III期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加，以及2）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在西南肿瘤组（SWOG）中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Curves减肥计划，该计划将基于循环的运动与高水果/蔬菜和低脂肪卡路里的饮食相结合，并在美国各地的5，000多家Curves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，以达到他们的目标，包括12个月的会员曲线健身设施，计步器跟踪日常活动，曲线饮食计划通过手册和在线膳食计划/饮食摄入量跟踪程序。该计划将辅以电话行为咨询，以增加教育，干预依从性和研究保留。共入组50例治疗后6个月至2年的癌症幸存者（25例乳腺癌幸存者和25例结直肠癌幸存者）。将利用SWOG的快速累积能力招募参与者。少数癌症幸存者将以26%的比例招募。本研究的主要目的是：1）根据研究累积、干预依从性和研究保留率，确定通过SWOG招募的超重和久坐女性乳腺癌和结直肠癌幸存者中基于社区的体力活动和饮食改变相结合的减肥干预的可行性; 2）估计干预对减肥的效应量。次要目的将评估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人群的能力以及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了可行性和e5%的体重减轻，研究结果将用于设计一项大型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的短期和长期体重减轻的影响;次要结局将检查体重减轻与无病生存期之间的关联。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生存时间。 公共卫生相关性：癌症幸存者人数不断增加，癌症幸存者中超重/肥胖的发病率也不断增加。观察性研究表明，诊断后较低的BMI与更好的乳腺癌和结直肠癌生存率相关，并且假设诊断后体重减轻将改善无病生存率。这项II期试点研究将测试在NCI西南肿瘤组使用曲线减肥计划结合电话管理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.