Development and Testing of Nutritional Algorithms (NACHO)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Development and Usability Testing of Nutrition Algorithms for Cancer Health Outcomes (NACHO) and Quality of Life During Cancer Treatment

Conditions
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Nutrition Poor, Nutritional Deficiency, Quality of Life

Intervention / Treatment
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* Behavioral: Nutrition Algorithm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria 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 Exclusion Criteria for Patient Participants • Provider does not recommend

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutrition Algorithm (NACHO)<br>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. | Behavioral: Nutrition Algorithm<br>* A technology-based platform for a person-centered nutrition program, providing suggested foods and recipes from dietitians.<br>* Other names: Nutrition Algorithm for Cancer Health Outcomes (NACHO) Program;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutrition Algorithm | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of Nutrition Algorithm for Cancer Health Outcomes (NACHO) Program | 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. | Up to 8 months | 
| Participant Satisfaction | 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. | Up to 8 months | 
| Panel member characteristics (Aims 1a, 1b, 2a, 2b) - Age | Age group (i.e., 18-29, 30-39, 40-49, 50-59, 60-69, 70-79, 80+) | Up to 12 months | 
| Panel member characteristics (Aims 1a, 1b, 2a, 2b) - Gender identity | Gender identity (i.e., female, male, other____, prefer not to answer) | Up to 12 months | 
| Panel member characteristics (Aims 1a, 1b, 2a, 2b) - Ethnicity | Ethnicity (i.e., Hispanic/Latinx / non-Hispanic/non-Latinx, prefer not to answer) | Up to 12 months | 
| Panel member characteristics (Aims 1a, 1b, 2a, 2b) - Race | Race (i.e., Black, Caucasian, Asian, Native American, Pacific Islander, Alaska Native, multiracial, prefer not to answer) | Up to 12 months | 
| Panel member characteristics (Aims 1a, 1b, 2a, 2b) - Position | Position / role and years in position (non-patient panel members only) (fill in) | Up to 12 months | 
| Characteristics of the cohort of 100 patients (Aim 3) - Age | Age group (i.e., 18-29, 30-39, 40-49, 50-59, 60-69, 70-79, 80+) | Up to 12 months | 
| Characteristics of the cohort of 100 patients (Aim 3) - Gender identity | Gender identity (i.e., female, male, other____, prefer not to answer) | Up to 12 months | 
| Characteristics of the cohort of 100 patients (Aim 3) - ethnicity | Ethnicity (i.e., Hispanic/Latinx / non-Hispanic/non-Latinx, prefer not to answer) | Up to 12 months | 
| Characteristics of the cohort of 100 patients (Aim 3) - race | Race (i.e., Black, Caucasian, Asian, Native American, Pacific Islander, Alaska Native, multiracial, prefer not to answer) | Up to 12 months | 
| Characteristics of the cohort of 100 patients (Aim 3) - BMI | 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 | Up to 12 months | 
| Characteristics of the cohort of 100 patients (Aim 3) - Comorbidities | Comorbidities: Number of comorbidities (e.g., heart disease, diabetes) will be abstracted from electronic health records | Up to 12 months | 
| Global Health | 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. | Up to 12 months | 
| Symptom Questions | 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. | Up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Poor Nutrition, Nutritional Deficiency, Quality of Life