Precise Oncology Interventions in Nutrition and Training (OnPoint)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 306
- 试验地点
- 1
- 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, colorectal or lymphoma 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, colorectal or lymphoma 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
研究组 & 干预措施
Low Complexity Group
Participants in this group will receive the low complexity intervention for up to eight (8) weeks.
干预措施: Fitbit (Other)
Moderate Complexity Group
Participants in this group will receive the moderate complexity intervention for up to eight (8) weeks.
干预措施: Nutrition and Physical Activity Prescription (Behavioral)
High Complexity Group
Participants in this group will receive the high complexity intervention for up to eight (8) weeks.
干预措施: Nutrition and Physical Activity Prescription (Behavioral)
Low Complexity Group
Participants in this group will receive the low complexity intervention for up to eight (8) weeks.
干预措施: Nutrition and Physical Activity Prescription (Behavioral)
Moderate Complexity Group
Participants in this group will receive the moderate complexity intervention for up to eight (8) weeks.
干预措施: Nutrition Course: Group Sessions (Behavioral)
Moderate Complexity Group
Participants in this group will receive the moderate complexity intervention for up to eight (8) weeks.
干预措施: Physical Activity Program: Group Sessions (Behavioral)
High Complexity Group
Participants in this group will receive the high complexity intervention for up to eight (8) weeks.
干预措施: Fitbit (Other)
High Complexity Group
Participants in this group will receive the high complexity intervention for up to eight (8) weeks.
干预措施: Nutrition Course: One on One Sessions with Registered Dietitian (Behavioral)
High Complexity Group
Participants in this group will receive the high complexity intervention for up to eight (8) weeks.
干预措施: Physical Activity Program: One on One Sessions with an Exercise Physiologist (Behavioral)
Moderate Complexity Group
Participants in this group will receive the moderate complexity intervention for up to eight (8) weeks.
干预措施: Fitbit (Other)
Control Group
Participants randomized to this arm will receive routine care and will not receive any study materials until the end of the study at 18 weeks.
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