Development and Usability Testing of Nutrition Algorithms for Cancer Health Outcomes (NACHO) and Quality of Life During Cancer Treatment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Nutrition Algorithm
研究概览
简要总结
The goal of this research study is to develop a nutrition algorithm to optimize nutritional status and improve quality of life during for participants who are completing or have completed cancer treatment.
The name of the intervention used in this research study is:
Nutrition Algorithm for Cancer Health Outcomes (NACHO) (a technology-based platform that houses the algorithms for the person-centered nutrition program)
详细描述
This is a longitudinal, mixed-methods, pilot descriptive study to develop a nutrition algorithm for cancer patients based on the Cancer Nutrition Consortium (CNC) study findings and refined through a dietitian panel participants and from feedback from participants and Family Advisory Council (PFAC) members.
Research study procedures include screening for eligibility, interviews and/or focus groups, dietitian panel meetings, and surveys.
Participation in this study is expected to last about 12 months.
It is expected about 130 people will participate in this research study.
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
- •for Dietitians/Oncology clinicians - Have worked with at least 3 patients at the study site who had nutritional challenges
- •Inclusion Criteria for Patient and Family Advisory Council (PFAC) participants
- •Current member of adult PFAC
- •> 18 years old
- •Inclusion Criteria for Patient participants
- •> 18 years old
- •Able to speak and read English
- •Completed primary treatment (aim 2b) or actively undergoing treatment (aim 2b and aim 3, exploratory)
- •Access to a device (e.g., computer, tablet, smartphone) through which they can receive and engage with a REDCap link
排除标准
- •for Patient Participants
- •Provider does not recommend
研究组 & 干预措施
Nutrition Algorithm (NACHO)
Study procedures will be conducted as follows:
- Development of nutrition algorithm by dietitian panel participants with oncology clinician consultation via convened group meetings.
- Refinement of draft algorithms through feedback from participants and Family Advisory Council (PFAC) members.
- Baseline questionnaires for participants.
- Semi-structured interviews and/or focus groups with participants to evaluate algorithm usability and acceptability.
- Participant questionnaires.
干预措施: Nutrition Algorithm (Behavioral)
结局指标
主要结局
Nutrition Algorithm
时间窗: 12 months
Primary study endpoint is development of a nutrition algorithm using the Cancer Nutrition Consortium (CNC) study findings and iteratively refine through an expert Dana-Farber Cancer Institute dietary panel along with consultations from oncology clinicians as needed and feedback from a panel of 4-6 Patient and Family Advisory Council (PFAC) members. Specific to data analyses, chi square, fisher's exact tests, and linear regression will be used to evaluate characteristics associated with changes in taste and different food preferences over time. Findings will inform the development of the algorithms.
次要结局
- Acceptability of Nutrition Algorithm for Cancer Health Outcomes (NACHO) Program(Up to 8 months)
- Participant Satisfaction(Up to 8 months)
- Panel member characteristics (Aims 1a, 1b, 2a, 2b) - Age(Up to 12 months)
- Panel member characteristics (Aims 1a, 1b, 2a, 2b) - Gender identity(Up to 12 months)
- Panel member characteristics (Aims 1a, 1b, 2a, 2b) - Ethnicity(Up to 12 months)
- Panel member characteristics (Aims 1a, 1b, 2a, 2b) - Race(Up to 12 months)
- Panel member characteristics (Aims 1a, 1b, 2a, 2b) - Position(Up to 12 months)
- Characteristics of the cohort of 100 patients (Aim 3) - Age(Up to 12 months)
- Characteristics of the cohort of 100 patients (Aim 3) - Gender identity(Up to 12 months)
- Characteristics of the cohort of 100 patients (Aim 3) - ethnicity(Up to 12 months)
- Characteristics of the cohort of 100 patients (Aim 3) - Comorbidities(Up to 12 months)
- Global Health(Up to 12 months)
- Symptom Questions(Up to 12 months)
- Characteristics of the cohort of 100 patients (Aim 3) - race(Up to 12 months)
- Characteristics of the cohort of 100 patients (Aim 3) - BMI(Up to 12 months)
研究者
Marilyn Hammer, PhD
Principal Investigator
Dana-Farber Cancer Institute