Survivors of Uterine Cancer Empowered By Exercise and Healthy Diet (SUCCEED)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Weight change
研究概览
简要总结
RATIONALE: Participating in a diet and exercise program may improve the quality of life of overweight and obese patients who are in remission from endometrial cancer.
PURPOSE: This randomized phase I trial is studying an exercise and healthy diet program to see how well it works compared with standard care in patients in remission from stage I or stage II endometrial cancer.
详细描述
PRIMARY OBJECTIVE:
* To reduce morbidity and early mortality in endometrial cancer (EC) survivors through obesity management.
SECONDARY OBJECTIVES:
- To expand and refine a previous pilot study of a behavioral, lifestyle-change education intervention for use in overweight and obese patients in remission from endometrial carcinoma.
- To determine the potential effects and variation of each regimen in these patients.
- To explore potential mediators (self-efficacy, depression) and moderators (body mass index) of healthful dietary and exercise behaviors.
- To evaluate neuronal response to high-versus-low calorie visual food stimuli under fasted (hunger) and fed (satiated) states in brain regions of interest (hypothalamus, lateral orbitofrontal cortex, ventral striatum, insula) using blood oxygenation level dependent (BOLD) functional magnetic resonance imaging (fMRI) before and after a lifestyle (diet and exercise counseling) intervention or usual care in obese EC patients. We will also compare the neuronal responses in obese EC patients to those from normal weight subjects without cancer being seen at the same gynecologic clinic; and, explore modification of the neuronal signals by candidate genes and serum biomarkers in the hypothalamic pituitary-adrenal axis, serotonergic and inflammatory pathways.
OUTLINE: Patients are stratified according to body mass index (25.0-39.9 vs ≥ 40) and randomized to 1 of 2 intervention arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed stage I or II (early) endometrial carcinoma
- •Diagnosed within the past 3 years
- •Underwent prior surgery consisting of a total abdominal hysterectomy and bilateral salpingo-oophorectomy
- •No evidence of disease
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •BMI ≥ 25 (overweight/obese)
- •Medical clearance from primary care physician
- •Approved for contact by treating gynecologic oncologist
- •At least a 6th-grade reading level to complete significant reading and homework
- •No severe psychiatric illness (e.g., schizophrenia, bipolar disorder) or major depression (Beck Depression Inventory > 29) that needs more aggressive, problem-focused interventions
- •No dementia or cognitive deficits
- •No pre-existing medical conditions that would be a barrier for participation in unsupervised walking
- •No participation in a structured weight loss or exercise program in the past 6 months
- •Must agree to and be available for longitudinal follow-up assessments
- •Non-English speakers may bring an English-speaking person to all group sessions and visits
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive a lifestyle intervention, "Survivors of Uterine Cancer Empowered by Exercise and Healthy Diet (SUCCEED)", on a group and individual basis consisting of nutrition, exercise, and behavioral modification counseling from a physician, psychologist, registered dietitian, and physical therapist. Sixteen group sessions will be conducted (10 weekly, 6 bi-weekly) for 6 months. Weight and body mass index, satisfaction with study treatment, and exercise/activity logs are assessed weekly and biweekly. Patients receive additional feedback and support during the weeks not met in a group, including newsletters and telephone and e-mail contact.
干预措施: behavioral dietary intervention (Behavioral)
Arm I
Patients receive a lifestyle intervention, "Survivors of Uterine Cancer Empowered by Exercise and Healthy Diet (SUCCEED)", on a group and individual basis consisting of nutrition, exercise, and behavioral modification counseling from a physician, psychologist, registered dietitian, and physical therapist. Sixteen group sessions will be conducted (10 weekly, 6 bi-weekly) for 6 months. Weight and body mass index, satisfaction with study treatment, and exercise/activity logs are assessed weekly and biweekly. Patients receive additional feedback and support during the weeks not met in a group, including newsletters and telephone and e-mail contact.
干预措施: exercise intervention (Behavioral)
Arm I
Patients receive a lifestyle intervention, "Survivors of Uterine Cancer Empowered by Exercise and Healthy Diet (SUCCEED)", on a group and individual basis consisting of nutrition, exercise, and behavioral modification counseling from a physician, psychologist, registered dietitian, and physical therapist. Sixteen group sessions will be conducted (10 weekly, 6 bi-weekly) for 6 months. Weight and body mass index, satisfaction with study treatment, and exercise/activity logs are assessed weekly and biweekly. Patients receive additional feedback and support during the weeks not met in a group, including newsletters and telephone and e-mail contact.
干预措施: counseling intervention (Other)
Arm I
Patients receive a lifestyle intervention, "Survivors of Uterine Cancer Empowered by Exercise and Healthy Diet (SUCCEED)", on a group and individual basis consisting of nutrition, exercise, and behavioral modification counseling from a physician, psychologist, registered dietitian, and physical therapist. Sixteen group sessions will be conducted (10 weekly, 6 bi-weekly) for 6 months. Weight and body mass index, satisfaction with study treatment, and exercise/activity logs are assessed weekly and biweekly. Patients receive additional feedback and support during the weeks not met in a group, including newsletters and telephone and e-mail contact.
干预措施: educational intervention (Other)
Arm I
Patients receive a lifestyle intervention, "Survivors of Uterine Cancer Empowered by Exercise and Healthy Diet (SUCCEED)", on a group and individual basis consisting of nutrition, exercise, and behavioral modification counseling from a physician, psychologist, registered dietitian, and physical therapist. Sixteen group sessions will be conducted (10 weekly, 6 bi-weekly) for 6 months. Weight and body mass index, satisfaction with study treatment, and exercise/activity logs are assessed weekly and biweekly. Patients receive additional feedback and support during the weeks not met in a group, including newsletters and telephone and e-mail contact.
干预措施: survey administration (Other)
Arm II
Patients receive usual care informational brochures but no lifestyle counseling related to weight loss, physical activity, and nutrition.
干预措施: educational intervention (Other)
结局指标
主要结局
Weight change
时间窗: at baseline and 3, 6, and 12 months.
Analysis will be carried out by fitting a mixed model. Weight change will be expressed in terms of absolute and relative weight change. In addition, percent weight change will be calculated. To test the null hypotheses that the groups do not differ in terms of change in weight at 6 or 12 months, parameter estimates from the model will be used to construct subsequent t-test that the difference in means at 3, 6, or 12 months is zero.
次要结局
- Quantitative and qualitative nutrient intake(at baseline and 3, 6, and 12 months.)
- Minutes spent in moderate and vigorous physical activity(at baseline and 3, 6, and 12 months.)
- Body composition, using dual energy x-ray absorptiometry/densitometry (DEXA) methodology(at baseline and 3, 6, and 12 months.)
- Biomarkers for metabolic syndrome and nutrition(at baseline and 3, 6, and 12 months.)
- Self-efficacy(at baseline and 3, 6, and 12 months.)
- Depression(at baseline and 3, 6, and 12 months.)
- Quality of life(at baseline and 3, 6, and 12 months.)