STRONG-PD: Support Through Remote Observation And Nutrition Guidance (STRONG) Program For Cancer Patients With Peritoneal Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Adherence to the STRONG Program
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 (STRONG) program. The program provides nutrition support for participants living with gastrointestinal cancer who are receiving chemotherapy and surgical 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
- •Gastrointestinal Cancer diagnosis (e.g., colon cancer, appendiceal cancer)
- •Peritoneal disease diagnosis
- •Received Cytoreductive Surgery and Heated Intra-Peritoneal Chemotherapy (CRS-HIPEC) for curative intent at Moffitt
- •Transitioned to an oral diet post-surgery
- •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
- •Receipt of parenteral or enteral nutrition after surgery
研究组 & 干预措施
STRONG Program
the STRONG program includes consultations with a Moffitt dietician, logging intake of food daily into a food diary with a Fitbit smartphone app, and completing questionnaires.
干预措施: Consultations with Moffitt Dietician (Behavioral)
STRONG Program
the STRONG program includes consultations with a Moffitt dietician, logging intake of food daily into a food diary with a Fitbit smartphone app, and completing questionnaires.
干预措施: Daily Food Intake Diary with Fitbit smartphone application (Behavioral)
STRONG Program
the STRONG program includes consultations with a Moffitt dietician, logging intake of food daily into a food diary with a Fitbit smartphone app, and completing questionnaires.
干预措施: Questionnaires (Behavioral)
结局指标
主要结局
Adherence to the STRONG Program
时间窗: at 16 weeks
Participant adherence to the Support through Remote Observation and Nutrition Guidance (STRONG) program will be assessed by Fitbit dietary log data and dietician care visit data.
Feasibility of the STRONG Program
时间窗: at 12 weeks
Feasibility of the Support through Remote Observation and Nutrition Guidance (STRONG) program will be assessed using recruitment and retention rates, along with data completion rates.
Acceptability of the STRONG Program
时间窗: at 16 weeks
The Acceptability of the STRONG Program measure uses 4 items to indicate participant satisfaction. The measure uses a scale of 0-5, 0 meaning the participant completely disagrees with the statements regarding intervention satisfaction and 5 indicating complete agreement with the statements regarding intervention satisfaction. The measure score ranges from 0-20 with 20 indicating the highest degree of satisfaction.
Efficacy of STRONG Program on Treatment Outcomes
时间窗: at 16 weeks
Efficacy of STRONG program on treatment outcomes will be measured by reviewing the Electronic Health Record for hospital readmissions and cause of readmission
次要结局
未报告次要终点