Support Through Remote Observation and Nutrition Guidance Program for Individuals With Pancreatic Cancer Undergoing Surgery (STRONG-PCS)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Retention Rate - Feasibility
研究概览
简要总结
The purpose of the study is to assess the feasibility and participant satisfaction with the Support through Remote Observation and Nutrition Guidance program. The program provides enhanced dietician access and nutrition support for participants living with pancreatic cancer who are undergoing surgery.
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
- 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
- •≥18 years old
- •Diagnosis of pancreatic cancer
- •Completed open pancreatic surgery (e.g., Whipple, distal/subtotal pancreatectomy, total pancreatectomy) for treatment at Moffitt Cancer Center
- •Discharged on an oral diet
- •Able to speak and read English or Spanish
- •Able to provide informed consent
排除标准
- •Determined to be ineligible for surgery during evaluation (e.g., cancer metastasis)
研究组 & 干预措施
STRONG-PCS Intervention
Participants will receive an initial in-person consultation with a dietician within 2 weeks of hospital discharge. Then participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth or in person and remote monitoring through a smart phone app and wearable sensor to allow participants to log food intake while sharing their data with a dietician.
干预措施: Fitbit Data Collection (Behavioral)
STRONG-PCS Intervention
Participants will receive an initial in-person consultation with a dietician within 2 weeks of hospital discharge. Then participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth or in person and remote monitoring through a smart phone app and wearable sensor to allow participants to log food intake while sharing their data with a dietician.
干预措施: Nutrition Counseling (Behavioral)
STRONG-PCS Intervention
Participants will receive an initial in-person consultation with a dietician within 2 weeks of hospital discharge. Then participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth or in person and remote monitoring through a smart phone app and wearable sensor to allow participants to log food intake while sharing their data with a dietician.
干预措施: Survey (Behavioral)
Usual Care
Participants will be referred for nutrition counseling from a dietitian based on clinical discretion.
干预措施: Nutrition Counseling (Behavioral)
Usual Care
Participants will be referred for nutrition counseling from a dietitian based on clinical discretion.
干预措施: Survey (Behavioral)
结局指标
主要结局
Retention Rate - Feasibility
时间窗: at 8 weeks
The study will be deemed feasible if ≥ 70% of participants enrolled at baseline will be retained at 8 weeks.
Participant Satisfaction - Acceptability
时间窗: at 8 weeks
The study will be deemed acceptable if ≥ 70% of participants rate the overall intervention as satisfactory using a validated 4-item scale (score range 0-20, score \>/= 12).
Participant Rating on Ease of Use the Mobile Application - Usability
时间窗: at 8 weeks
The study will be deemed usable if ≥ 60% of participants rate the mobile application as easy-to-use for logging dietary intake using a validated 10-item scale (score range from 0-100, score of \>/=60).
Data Collection - Feasibility
时间窗: at 8 weeks
The study will be deemed feasible if ≥ 70% of participants log food for greater than 80% of study days.
Recruitment Rate - Feasibility
时间窗: Up to 48 months
The study will be deemed feasible if ≥ 50% of eligible participants are enrolled.
次要结局
- Quality of Life(at Baseline, 4, 8 and 12 weeks)
- Malnutrition - Low BMI(at Baseline, 30, 60 and 90 days)
- Malnutrition - Low Skeletal Muscle Mass(At baseline, 30, 60 and 90 days)
- Malnutrition-Significant weight loss(90 days)
- Hospital Readmissions(30, 60 and 90 days post-hospital discharge)
- Malnutrition -Nutritional Status(at Baseline, 30, 60 and 90 days)