Development and Testing of Nutritional Algorithms (NACHO)

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

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Quality of Life; Nutrition Poor; Nutritional Deficiency
• Intervention / Treatment: Behavioral: Nutrition Algorithm

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.

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marilyn Hammer, MD; Phone Number: 617-632-1909; Email: MarilynJ_Hammer@dfci.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: Nutrition Algorithm; A technology-based platform for a person-centered nutrition program, providing suggested foods and recipes from dietitians.; Other Names: Nutrition Algorithm for Cancer Health Outcomes (NACHO) Program

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: Cancer Nutrition Consortium Inc.
• Investigators: Principal Investigator: Marilyn Hammer, MD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: February 27, 2023
• First Submitted That Met QC Criteria: April 21, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Quality of Life; Nutritional Deficiency; Poor Nutrition
• Additional Relevant MeSH Terms: Nutrition Disorders; Nutritional and Metabolic Diseases; Malnutrition
• Other Study ID Numbers: 22-637

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No