NCT05825469

Brief 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. 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)

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed
3.4 years until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

February 27, 2023

Last Update Submit

February 3, 2026

Conditions

Keywords

Poor NutritionNutritional DeficiencyQuality of Life

Outcome Measures

Primary Outcomes (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.

    12 months

Secondary Outcomes (15)

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

    Up to 8 months

  • Participant Satisfaction

    Up to 8 months

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

    Up to 12 months

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

    Up to 12 months

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

    Up to 12 months

  • +10 more secondary outcomes

Study Arms (1)

Nutrition Algorithm (NACHO)

EXPERIMENTAL

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

Interventions

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

Also known as: Nutrition Algorithm for Cancer Health Outcomes (NACHO) Program
Nutrition Algorithm (NACHO)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current member of adult PFAC
  • \> 18 years old
  • \> 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

You may not qualify if:

  • Provider does not recommend

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Marilyn Hammer, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 27, 2023

First Posted

April 24, 2023

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

February 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data can be shared no earlier than 1 year following the date of publication
Access Criteria
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations