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)
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
130
A technology-based platform for a person-centered nutrition program, providing suggested foods and recipes from dietitians.
Dana Farber Cancer Institute
Boston, Massachusetts, United States
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.
Time frame: 12 months
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.
Time frame: 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.
Time frame: 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+)
Time frame: 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)
Time frame: Up to 12 months
Panel member characteristics (Aims 1a, 1b, 2a, 2b) - Ethnicity
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Ethnicity (i.e., Hispanic/Latinx / non-Hispanic/non-Latinx, prefer not to answer)
Time frame: 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)
Time frame: 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)
Time frame: 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+)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Up to 12 months