Lifestyle Interventions to Improve Physical Function and Quality of Life in Endometrial Cancer Survivors: The Role of a Gentle Yoga Based Exercise Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Examine change from baseline in physical function as measured by the Short Physical Performance Battery (SPPB).
研究概览
简要总结
This randomized clinical trial studies how well gentle yoga and dietary counseling lifestyle change effects physical function and quality of life of endometrial cancer survivors. Gentle yoga and dietary counseling may help improve physical function and quality of life for stage I-II endometrial cancer survivors.
详细描述
PRIMARY OBJECTIVES:
I. To determine the feasibility and efficacy of a combined lifestyle intervention (yoga + diet) to positively impact physical function and quality of life for endometrial cancer survivors.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Participants undergo onsite gentle yoga once weekly over 45-60 minutes for 8 weeks and home-based gentle yoga for 6 weeks. Participants also undergo dietary counseling over 8 weeks.
ARM II: Participants undergo enhanced usual care designed to educate on best practices for exercise, diet and lifestyle change once weekly for 14 weeks.
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
- Single (Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •English speaking
- •Previous diagnosis of grade 1 or 2, stage I or II endometrioid endometrial cancers ("type I cancers") as confirmed during surgical intervention for treatment
- •Overweight or obese (> 25 kg/m^2)
- •Anytime from treatment
- •Treating oncologist consent
- •Primary physician consent to engage in physical activity unsupervised
- •Ambulatory or able to engage in walking for at least 15 minutes
- •Sedentary lifestyle, as engaging in less than 100 minutes structured aerobic walking, cycling or swimming per week
排除标准
- •No prior type I endometrial cancer diagnosis
- •Prior diagnosis of other cancer
- •Currently (previous 6 months) engaged in structured exercise either aerobic or yoga based
- •Severe heart or systemic disease: evidence of documented myocardial infarction, chronic unstable angina, symptomatic congestive heart failure, uncontrolled hypertension
- •Severe musculoskeletal disease: severe muscle or joint disorders due to disease or trauma, amputations, or any condition that significantly impair physical capabilities, as defined by the physician
- •Non-ambulatory
- •Concurrent diagnosis of organic brain syndrome, dementia, mental retardation, or significant sensory deficit
- •Major mental illness (e.g., schizophrenia, major depressive disorder)
- •Unwilling to give consent
研究组 & 干预措施
Arm I (gentle yoga and dietary counseling)
Participants undergo onsite gentle yoga once weekly over 45-60 minutes for 8 weeks and home-based gentle yoga for 6 weeks. Participants also undergo dietary counseling over 8 weeks.
干预措施: Gentle yoga therapy (Procedure)
Arm I (gentle yoga and dietary counseling)
Participants undergo onsite gentle yoga once weekly over 45-60 minutes for 8 weeks and home-based gentle yoga for 6 weeks. Participants also undergo dietary counseling over 8 weeks.
干预措施: counseling intervention (Other)
Arm I (gentle yoga and dietary counseling)
Participants undergo onsite gentle yoga once weekly over 45-60 minutes for 8 weeks and home-based gentle yoga for 6 weeks. Participants also undergo dietary counseling over 8 weeks.
干预措施: quality-of-life assessment (Other)
Arm I (gentle yoga and dietary counseling)
Participants undergo onsite gentle yoga once weekly over 45-60 minutes for 8 weeks and home-based gentle yoga for 6 weeks. Participants also undergo dietary counseling over 8 weeks.
干预措施: questionnaire administration (Other)
Arm II (enhanced usual care)
Participants undergo enhanced usual care designed to educate on best practices for exercise, diet and lifestyle change once weekly for 14 weeks.
干预措施: educational intervention (Other)
Arm II (enhanced usual care)
Participants undergo enhanced usual care designed to educate on best practices for exercise, diet and lifestyle change once weekly for 14 weeks.
干预措施: quality-of-life assessment (Other)
Arm II (enhanced usual care)
Participants undergo enhanced usual care designed to educate on best practices for exercise, diet and lifestyle change once weekly for 14 weeks.
干预措施: questionnaire administration (Other)
结局指标
主要结局
Examine change from baseline in physical function as measured by the Short Physical Performance Battery (SPPB).
时间窗: Up to 14 weeks
Physical function will be assess using a SPPB walk performance assessment. Quality life will be assessed via the SF-36 and the Functional Assessment of Cancer Therapy-Endometrial FACT-EN.
次要结局
- Examine intervention feasibility using a composite assessment.(Up to 14 weeks)
研究者
Brian Focht
Principal Investigator
Ohio State University Comprehensive Cancer Center