Development and Testing of Nutritional Algorithms (NACHO)
- Conditions
- Nutrition PoorNutritional DeficiencyQuality of Life
- Interventions
- Behavioral: Nutrition Algorithm
- Registration Number
- NCT05825469
- Lead Sponsor
- Dana-Farber Cancer Institute
- Brief Summary
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)
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 130
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nutrition Algorithm (NACHO) Nutrition Algorithm 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.
- Primary Outcome Measures
Name Time Method Nutrition Algorithm 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.
- Secondary Outcome Measures
Name Time Method Participant Satisfaction Up to 8 months Assessed using the Acceptability e-Scale (AES), a six-item scale that measures how easy, enjoyable, understandable, and helpful the intervention is. Total scores range from 6-30 with higher scores representing greater acceptability. Acceptability is defined as a AES score of \>24.
Acceptability of Nutrition Algorithm for Cancer Health Outcomes (NACHO) Program Up to 8 months Assessed using the System Usability Scale (SUS), a 10-item instrument with scores that range from 0-100 with higher scores representing greater usability. Acceptability is defined as a SUS score of \>70.
Panel member characteristics (Aims 1a, 1b, 2a, 2b) - Age Up to 12 months Age group (i.e., 18-29, 30-39, 40-49, 50-59, 60-69, 70-79, 80+)
Characteristics of the cohort of 100 patients (Aim 3) - BMI Up to 12 months Body mass index will will be calculated from weight in pounds and height in inches using the formula: weight (lb) / \[height (in)\]squared x 703
Symptom Questions Up to 12 months Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAETM) will be used to collect data on the occurrence, severity, and level of interference with daily activities for sleep quality (i.e., insomnia), pain, fatigue, and depression (i.e., anxiety, discouraged, sad) at baseline, 2 months, and 5 months (respectively visits 1, 3, and 6). Higher scores will indicate worse symptom experiences. T-scores will be used in the analysis to identify characteristics associated with other participant patients at the same global health levels. Changes in T-scores over time will be compared with changes in BMI and associated with utilization of the nutrition algorithm.
Panel member characteristics (Aims 1a, 1b, 2a, 2b) - Position Up to 12 months Position / role and years in position (non-patient panel members only) (fill in)
Characteristics of the cohort of 100 patients (Aim 3) - Gender identity Up to 12 months Gender identity (i.e., female, male, other____, prefer not to answer)
Characteristics of the cohort of 100 patients (Aim 3) - ethnicity Up to 12 months Ethnicity (i.e., Hispanic/Latinx / non-Hispanic/non-Latinx, prefer not to answer)
Panel member characteristics (Aims 1a, 1b, 2a, 2b) - Gender identity Up to 12 months Gender identity (i.e., female, male, other____, prefer not to answer)
Characteristics of the cohort of 100 patients (Aim 3) - race Up to 12 months Race (i.e., Black, Caucasian, Asian, Native American, Pacific Islander, Alaska Native, multiracial, prefer not to answer)
Panel member characteristics (Aims 1a, 1b, 2a, 2b) - Ethnicity Up to 12 months Ethnicity (i.e., Hispanic/Latinx / non-Hispanic/non-Latinx, prefer not to answer)
Panel member characteristics (Aims 1a, 1b, 2a, 2b) - Race Up to 12 months Race (i.e., Black, Caucasian, Asian, Native American, Pacific Islander, Alaska Native, multiracial, prefer not to answer)
Characteristics of the cohort of 100 patients (Aim 3) - Age Up to 12 months Age group (i.e., 18-29, 30-39, 40-49, 50-59, 60-69, 70-79, 80+)
Characteristics of the cohort of 100 patients (Aim 3) - Comorbidities Up to 12 months Comorbidities: Number of comorbidities (e.g., heart disease, diabetes) will be abstracted from electronic health records
Global Health Up to 12 months PROMIS-10 Global Health Questionnaire v.1.2 is an NIH-developed, valid and reliable instrument that will be used to assess functional status and quality of life. Higher scores represent better health. Scores will be computed to identify global physical and mental health component scores. Participant patients will complete this assessment at baseline, 2 months, and 5 months (visits 1, 3, and 6, respectively). T-scores will be used in the analysis to identify characteristics associated with other participant patients at the same global health levels. Changes in T-scores over time will be compared with changes in BMI and associated with utilization of the nutrition algorithm.
Trial Locations
- Locations (1)
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States