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Nutrition PoorNCT05825469

Development and Testing of Nutritional Algorithms (NACHO)

A study testing Nutrition Algorithm in people with Nutrition Poor and Nutritional Deficiency, run by Dana-Farber Cancer Institute at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nutrition Algorithm
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
1 siteUnited States
Study dates
1 Sep 2026to 31 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • > 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

Who cannot join

  • Provider does not recommend

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Marilyn Hammer, MD contact

617-632-1909

MarilynJ_Hammer@dfci.harvard.edu

United States1 site

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: 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)

Read the 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.

Being tested
Nutrition Algorithm
Keywords
Poor Nutrition, Nutritional Deficiency, Quality of Life
Medical subject headings
Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutrition AlgorithmBehavioural

    Also called Nutrition Algorithm for Cancer Health Outcomes (NACHO) Program

    A technology-based platform for a person-centered nutrition program, providing suggested foods and recipes from dietitians.

Study groups in NCT05825469
Study groupRoleWhat they receive
Nutrition Algorithm (NACHO)ExperimentalStudy 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.
Receives: Behavioral: Nutrition Algorithm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

Secondary outcomes (15)

  1. 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.

    Measured: Up to 8 months

  2. 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.

    Measured: Up to 8 months

  3. 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+)

    Measured: Up to 12 months

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

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

    Measured: Up to 12 months

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

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

    Measured: Up to 12 months

  6. 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)

    Measured: Up to 12 months

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

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

    Measured: Up to 12 months

  8. 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+)

    Measured: Up to 12 months

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

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

    Measured: Up to 12 months

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

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

    Measured: Up to 12 months

  11. 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)

    Measured: Up to 12 months

  12. 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

    Measured: Up to 12 months

  13. 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

    Measured: Up to 12 months

  14. 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.

    Measured: Up to 12 months

  15. 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.

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2023
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05825469
Sponsor's protocol ID
22-637
Status last verified
Feb 2026
First submitted
27 Feb 2023
Last updated
6 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Nutrition Algorithm in people with Nutrition Poor and Nutritional Deficiency, run by Dana-Farber Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marilyn Hammer, MD (617-632-1909, MarilynJ_Hammer@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nutrition Algorithm (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05825469.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.

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