Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Gastroesophageal Cancer (GEC) Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Participant Satisfaction - Acceptability
研究概览
简要总结
The purpose of the study is to assess the feasibility and patient satisfaction with the Support through Remote Observation and Nutrition Guidance (STRONG) program. The program provides nutrition support for participants living with gastroesophageal cancer who are receiving chemotherapy and radiation treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Locally advanced or metastatic GEC diagnosis
- •Planned to initiate chemoradiation and/or radiation therapy with a plan to have surgery or a plan to have definitive treatment at Moffitt.
- •Able to speak and read English
- •Able to provide informed consent
排除标准
- •Documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g., psychosis, active substance abuse)
- •Undergoing concurrent treatment for a secondary primary cancer
- •Use of feeding tubes before enrollment (The last exclusion criterion was included because investigators do not anticipate these participants would benefit from a dietary monitoring intervention)
研究组 & 干预措施
STRONG-GEC
Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth 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-GEC
Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth 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-GEC
Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth 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)
结局指标
主要结局
Participant Satisfaction - Acceptability
时间窗: 12 Months
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).
Data Collection - Feasibility
时间窗: 12 Months
The study will be deemed feasible if ≥ 60% of participants submit 3/4 study assessments
Recruitment Rate - Feasibility
时间窗: 12 Months
The study will be deemed feasible if ≥ 50% of eligible participants are enrolled
Retention Rate - Feasibility
时间窗: 12 Months
The study will be deemed feasible if ≥ 70% of participants enrolled at baseline will be retained at 8 weeks
Participant Rating on Ease of Use the Mobile Application - Usability
时间窗: 12 Months
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).
次要结局
- Participant Compliance with Dietary Log - Intervention adherence(12 Months)
- Participant Compliance with Dietician Visit - Intervention adherence(12 Months)