NCT06534918招募中不适用
Precise Oncology Interventions in Nutrition and Training (OnPoint)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 306
- 试验地点
- 2
- 主要终点
- Percentage of Interventions Sessions Completed
研究概览
简要总结
The purpose of this study is to see if survivors of breast, prostate, or colorectal cancer who receive a personal referral to a targeted nutrition and exercise program will be able to eat a healthier diet and be more physically activity.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria - Healthcare Providers
- •Provide full- or part-time care in an oncology clinical care setting at Sylvester Comprehensive Cancer Center
- •Utilize the electronic medical record for patient documentation on a regular basis
- •Willing to complete a 30-60-minute interview
- •Inclusion Criteria - Patients
- •18 years of age or older
- •Any sex/gender
- •Able to provide consent
- •Able to read/understand English or Spanish
- •Diagnosis of breast, prostate or colorectal cancer, 6 months post completion of primary treatment, with no evidence of primary disease
- •Approval from treating oncologist, confirmed via email or in writing
- •Fail to meet at least one of the American Cancer Society guidelines: engaging in >150 minutes of moderate-to-vigorous physical activity per week for the prior month or consuming at least 3 cups of vegetables and 2 cups of fruit per day over the past month.
- •Internet access on a smart phone, tablet, or computer
- •Agree to be randomly assigned to any study group
排除标准
- •Less than 18 years of age
- •Unable to provide consent
- •Unable to read/understand English or Spanish
- •Any contraindication for diet change or exercising as determined by physician
- •Engaging in >150 minutes of moderate to vigorous physical activity on average per week for the prior month
- •Meeting the American Cancer Society diet recommendations (3 cups of vegetables or legumes, 2 cups of fruit, 2 serving whole grain per day, and limited red/processed meats, sugar-sweetened beverages, and highly processed foods) for the prior month
- •History of dementia or major psychiatric disease which would interfere with study participation
- •History of recent (≤1 yr) stroke, myocardial infarction or congestive heart failure
- •Eastern Cooperative Oncology Group (ECOG) score of >2
- •Severe lymphedema as determined by physician
- •Receiving physical therapy treatment
结局指标
主要结局
Percentage of Interventions Sessions Completed
时间窗: Up to 8 Weeks
Percentage of intervention sessions completed will be reported as ≥ 80%.
Percentage of Survivors Who Agree to Participate
时间窗: Up to 8 Weeks
Percentage of survivors who agree to participate will be reported as ≥ 50%.
Percentage of Participants Satisfied with the Intervention
时间窗: Up to 8 Weeks
Report of 80% satisfaction will be determined as satisfaction with intervention components.
次要结局
未报告次要终点
研究者
Tracy E Crane, PhD, RDN
Associate Professor
University of Miami
研究点 (2)
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