A Randomized Trial of a Multimodal Lifestyle Intervention to Optimize Survivorship After Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Change in cardiorespiratory fitness capacity (co-primary)
研究概览
简要总结
To examine the efficacy of a 10-week multimodal lifestyle program, versus waitlist control, on cardiorespiratory fitness capacity and body weight in survivors of cancer.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide informed consent before any trial-related activities
- •History of any malignancy
- •Completion of cancer-directed therapy (e.g., surgery, chemotherapy, and radiotherapy) prior to enrollment (patients receiving ongoing endocrine or targeted therapy are eligible to participate)
- •No evidence of residual or recurrent cancer under active treatment
- •Age ≥18 years
- •Body mass index (BMI) ≥30 kg/m2 or BMI ≥27 kg/m2 with one or more treated or untreated weight-related coexisting conditions
- •Willing to be randomized
- •Allow the collection and storage of biospecimens and data for future use
排除标准
- •Engaging in ≥3 purposeful exercise sessions per week, on average, over the past 12 weeks
- •Significant purposeful weight loss (>11 kg) within the past 12 weeks
- •Current use of medications or devices for the purpose of weight loss
- •Metabolic or bariatric surgery within the last year
- •Cardiovascular, respiratory, or musculoskeletal disease that would prohibit participation in an exercise and weight loss program
- •Currently pregnant, breastfeeding, or planning to become pregnant with the next 12 weeks
- •Psychiatric disorders or conditions that would preclude participation in the study intervention
- •Any other condition which, in the opinion of the investigator, may impede testing of the study hypothesis or make it unsafe to engage in the study
研究组 & 干预措施
Waitlist Control
The waitlist control group will be asked to maintain their current exercise and dietary habits for the 10-week study period. Upon providing study endpoint data at week 10, control group participants will be offered a 4-week multimodal lifestyle program that is similar to the intervention group.
Multimodal Lifestyle Program
The multimodal lifestyle program will utilize intensive behavioral therapy with structured exercise training and nutritional counseling. The main objective of the structured exercise training is to improve cardiorespiratory fitness.
干预措施: Multimodal Lifestyle Program (Behavioral)
结局指标
主要结局
Change in cardiorespiratory fitness capacity (co-primary)
时间窗: Baseline, Week 10
Cardiorespiratory fitness (VO2peak) assessed by a symptom-limited cardiopulmonary exercise test.
Change in body weight (co-primary)
时间窗: Baseline, Week 10
Bodyweight assessed using a digital scale in a fasting state with an empty bladder, without shoes, and only wearing light clothing.
次要结局
- Change in systolic blood pressure(Baseline, Week 10)
- Change in fat Mass(Baseline, Week 10)
- Change in waist Circumference(Baseline, Week 10)
- Change in diastolic blood pressure(Baseline, Week 10)
- Change in physical and mental quality-of-life(Baseline, Week 10)
- Change in medication use(Baseline, Week 10)
研究者
Justin Brown
Assistant Professor
Pennington Biomedical Research Center