Lifestyle Change and Quality of Life in Obese Endometrial Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Quality of life as measured by Functional Assessment of Cancer Therapy for General Cancer (FACT-G) and Functional Assessment of Cancer Therapy for Fatigue (FACT-F) at baseline, 3, 6, and 12 months
研究概览
简要总结
RATIONALE: Exercise and dietary counseling may affect weight loss and improve the quality of life of obese endometrial cancer patients and may help them live longer and more comfortably.
PURPOSE: This randomized clinical trial is studying the effects of exercise and dietary counseling on weight loss and quality of life of obese patients with stage I or stage II endometrial cancer in remission.
详细描述
OBJECTIVES:
Primary
- Determine the combined effect of exercise and dietary counseling on the weight loss and quality of life of obese patients with stage I or II endometrial cancer in remission.
Secondary
- Determine the feasibility and acceptability of lifestyle interventions in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed endometrial cancer meeting the following criteria:
- •Stage I or II disease
- •Post-operative total abdominal hysterectomy and bilateral salpingo-oophorectomy
- •Disease in remission
- •Body Mass Index (BMI) ≥ 25
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •PRIOR CONCURRENT THERAPY: Not specified
排除标准
- 未提供
研究组 & 干预措施
Lifestyle counseling
Patients undergo weekly contact with a dietitian; exercise intervention for 6 months; and physician counseling.Patients undergo quality of life, exercise, and clinical assessments at baseline and at 3, 6, and 12 months.
干预措施: behavioral dietary intervention (Behavioral)
Lifestyle counseling
Patients undergo weekly contact with a dietitian; exercise intervention for 6 months; and physician counseling.Patients undergo quality of life, exercise, and clinical assessments at baseline and at 3, 6, and 12 months.
干预措施: quality-of-life assessment (Procedure)
Lifestyle counseling
Patients undergo weekly contact with a dietitian; exercise intervention for 6 months; and physician counseling.Patients undergo quality of life, exercise, and clinical assessments at baseline and at 3, 6, and 12 months.
干预措施: counseling intervention (Other)
Lifestyle counseling
Patients undergo weekly contact with a dietitian; exercise intervention for 6 months; and physician counseling.Patients undergo quality of life, exercise, and clinical assessments at baseline and at 3, 6, and 12 months.
干预措施: educational intervention (Other)
Lifestyle counseling
Patients undergo weekly contact with a dietitian; exercise intervention for 6 months; and physician counseling.Patients undergo quality of life, exercise, and clinical assessments at baseline and at 3, 6, and 12 months.
干预措施: preventative dietary intervention (Other)
Without Counseling
Patients undergo quality of life, exercise, and clinical assessments at baseline and at 3, 6, and 12 months.
干预措施: quality-of-life assessment (Procedure)
结局指标
主要结局
Quality of life as measured by Functional Assessment of Cancer Therapy for General Cancer (FACT-G) and Functional Assessment of Cancer Therapy for Fatigue (FACT-F) at baseline, 3, 6, and 12 months
时间窗: baseline, 3, 6, and 12 months
Comorbidities as measured by Charlson Co-Morbidity Score at baseline, 3, 6, and 12 months
时间窗: baseline, 3, 6, and 12 months
Weight loss as measured by weight, body mass index (BMI), waist circumference, Weight Efficacy Life Style Questionnaire, Three Factor Eating Inventory Questionnaire, and Leisure Score index at baseline, 3, 6, and 12 months
时间窗: baseline, 3, 6, and 12 months
Functional status as measured by ECOG performance status, and short-form health survey with 36 questions (SF-36)
时间窗: baseline, 3, 6, and 12 months
次要结局
未报告次要终点