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

• 批准号: 8247704
• 负责人: Heather Greenlee
• 金额: $ 17.16万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 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/8247704
• 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; public health relevance; saturated fat; secondary outcome; sedentary; socioeconomics; tumor; waist circumference; weight loss intervention

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.

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）获得在现实世界环境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/饮食摄入跟踪计划进行的 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。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、干预依从性和研究保留情况，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身体活动和饮食改变相结合的减肥干预的可行性；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) 身体活动、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，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 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。 公共卫生相关性：癌症幸存者的数量不断增加，癌症幸存者中超重/肥胖的发生率也在不断增加。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存活率相关，并且假设诊断后减肥将改善无病生存率。这项第二阶段试点研究将测试在 NCI 西南肿瘤学小组中使用 Curves 减肥计划与电话行为咨询相结合进行减肥干预的可行性。