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NCT Number: NCT05825469

Development and Testing of Nutritional Algorithms (NACHO)

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)

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutrition Algorithm

Behavioral

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

Primary outcomes

  1. Nutrition Algorithm

    Time frame: 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 outcomes

  1. Acceptability of Nutrition Algorithm for Cancer Health Outcomes (NACHO) Program

    Time frame: 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.

  2. Participant Satisfaction

    Time frame: 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.

  3. Panel member characteristics (Aims 1a, 1b, 2a, 2b) - Age

    Time frame: Up to 12 months

    Age group (i.e., 18-29, 30-39, 40-49, 50-59, 60-69, 70-79, 80+)

  4. Panel member characteristics (Aims 1a, 1b, 2a, 2b) - Gender identity

    Time frame: Up to 12 months

    Gender identity (i.e., female, male, other____, prefer not to answer)

  5. Panel member characteristics (Aims 1a, 1b, 2a, 2b) - Ethnicity

    Time frame: Up to 12 months

    Ethnicity (i.e., Hispanic/Latinx / non-Hispanic/non-Latinx, prefer not to answer)

  6. Panel member characteristics (Aims 1a, 1b, 2a, 2b) - Race

    Time frame: Up to 12 months

    Race (i.e., Black, Caucasian, Asian, Native American, Pacific Islander, Alaska Native, multiracial, prefer not to answer)

  7. Panel member characteristics (Aims 1a, 1b, 2a, 2b) - Position

    Time frame: Up to 12 months

    Position / role and years in position (non-patient panel members only) (fill in)

  8. Characteristics of the cohort of 100 patients (Aim 3) - Age

    Time frame: Up to 12 months

    Age group (i.e., 18-29, 30-39, 40-49, 50-59, 60-69, 70-79, 80+)

  9. Characteristics of the cohort of 100 patients (Aim 3) - Gender identity

    Time frame: Up to 12 months

    Gender identity (i.e., female, male, other____, prefer not to answer)

  10. Characteristics of the cohort of 100 patients (Aim 3) - ethnicity

    Time frame: Up to 12 months

    Ethnicity (i.e., Hispanic/Latinx / non-Hispanic/non-Latinx, prefer not to answer)

  11. Characteristics of the cohort of 100 patients (Aim 3) - race

    Time frame: Up to 12 months

    Race (i.e., Black, Caucasian, Asian, Native American, Pacific Islander, Alaska Native, multiracial, prefer not to answer)

  12. Characteristics of the cohort of 100 patients (Aim 3) - BMI

    Time frame: 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

  13. Characteristics of the cohort of 100 patients (Aim 3) - Comorbidities

    Time frame: Up to 12 months

    Comorbidities: Number of comorbidities (e.g., heart disease, diabetes) will be abstracted from electronic health records

  14. Global Health

    Time frame: 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.

  15. Symptom Questions

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marilyn Hammer, MD

CONTACT

[email protected]

617-632-1909

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Cancer Nutrition Consortium Inc.

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 24, 2023
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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