Physical Activity and Nutrition to Halt Elevated Risk in the Pancreas Interception Center (PANTHER-PIC)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Retention Feasibility
研究概览
简要总结
The purpose of this Study is to assist in implementing a practical, easy-to-adopt lifestyle intervention that optimizes patient outcomes and minimizes pancreatic ductal adenocarcinoma (PDAC) risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Age 18 years or older
- •Endoscopically, radiologically, or biopsy-proven pancreatic intraductal papillary mucinous neoplasm (IPMN) over 15 mm in size
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Ability to sign informed consent
- •Ability to read and speak English or Spanish
- •Body Mass Index (BMI) greater than or equal to 25 kg/m2
- •Visceral obesity based on MRI quantification of visceral and subcutaneous fat; ratio of visceral to subcutaneous fat area greater than 0.4 and/or elevated cytokine, incretin or adipokine biomarkers
排除标准
- •No diagnosis of an IPMN
- •IPMN with high grade dysplasia, cancer or other high-risk features
- •Screen failure for exercise safety
- •Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease
- •Recent fracture or acute musculoskeletal injury
- •Numeric pain rating scale of 7 or more out of 10
- •Myopathic or rheumatologic disease that impacts physical function
研究组 & 干预措施
Physical Activity (PA) and Nutrition (N)
Physical Activity: Participants will perform 150 minutes/week of moderate to vigorous Physical Activity per week. Participants will self-monitor physical activity using "active minutes" that approximate moderate to vigorous physical activity via a Fitbit device.
Nutrition: Participants will undergo counseling appointments to address nutritional symptoms and will be given targets for daily calorie and protein intake following a Mediterranean diet.
干预措施: Physical Activity (PA) (Behavioral)
Physical Activity (PA) and Nutrition (N)
Physical Activity: Participants will perform 150 minutes/week of moderate to vigorous Physical Activity per week. Participants will self-monitor physical activity using "active minutes" that approximate moderate to vigorous physical activity via a Fitbit device.
Nutrition: Participants will undergo counseling appointments to address nutritional symptoms and will be given targets for daily calorie and protein intake following a Mediterranean diet.
干预措施: Nutrition (N) (Behavioral)
结局指标
主要结局
Retention Feasibility
时间窗: Up to 6 Months
Retention feasibility will be measured based on the percentage of enrolled participants who complete study assessments during the 6-month duration of enrollment (baseline T0 through follow-up T1) Target: ≥70%).
Physical Activity (PA) Adherence Feasibility
时间窗: Up to 6 Months
Adherence to Physical Activity (PA) will be based on achievement of activity minute goals (≥ 150 minutes). Target: 70% of participants achieve activity minute goals in ≥75% of full weeks between baseline through follow-up (T0-T1).
Nutrition (N) Adherence Feasibility
时间窗: Up to 6 Months
Adherence to Nutrition (N) will be based on completion of counseling appointments (target: 70% of participants complete both appointments) and diet logging. Target: 70% of participants log diet on ≥ 50% of days between baseline through follow-up (T0-T1)
Acceptability of Lifestyle Modifications
时间窗: Up to 6 Months
Acceptability will be assessed at T1 with the Participant Evaluation of Feasibility and Acceptability questionnaire, adapted to fit intervention conditions used in this study. This questionnaire includes Likert Scale and open-ended questions assessing difficulty and appropriateness of the Physical Acitivity (PA) and Nutrition (N) intervention components, perceived benefits, interactions with study personnel, study materials, and baseline/follow-up testing. Acceptability will be assessed on an item-by-item basis and as average item score, with scores ≥4 ("agree" to "strongly agree") indicating acceptability.
次要结局
未报告次要终点