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Development and Testing of Nutritional Algorithms (NACHO)

Primary Purpose

Nutrition Poor, Nutritional Deficiency, Quality of Life

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nutrition Algorithm
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nutrition Poor focused on measuring Poor Nutrition, Nutritional Deficiency, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dana Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nutrition Algorithm (NACHO)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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+)
Panel member characteristics (Aims 1a, 1b, 2a, 2b) - Gender identity
Gender identity (i.e., female, male, other____, prefer not to answer)
Panel member characteristics (Aims 1a, 1b, 2a, 2b) - Ethnicity
Ethnicity (i.e., Hispanic/Latinx / non-Hispanic/non-Latinx, prefer not to answer)
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)
Panel member characteristics (Aims 1a, 1b, 2a, 2b) - Position
Position / role and years in position (non-patient panel members only) (fill in)
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+)
Characteristics of the cohort of 100 patients (Aim 3) - Gender identity
Gender identity (i.e., female, male, other____, prefer not to answer)
Characteristics of the cohort of 100 patients (Aim 3) - ethnicity
Ethnicity (i.e., Hispanic/Latinx / non-Hispanic/non-Latinx, prefer not to answer)
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)
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
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
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.
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.

Full Information

First Posted
February 27, 2023
Last Updated
September 4, 2023
Sponsor
Dana-Farber Cancer Institute
Collaborators
Cancer Nutrition Consortium Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05825469
Brief Title
Development and Testing of Nutritional Algorithms (NACHO)
Official Title
Development and Usability Testing of Nutrition Algorithms for Cancer Health Outcomes (NACHO) and Quality of Life During Cancer Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Cancer Nutrition Consortium Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutrition Poor, Nutritional Deficiency, Quality of Life
Keywords
Poor Nutrition, Nutritional Deficiency, Quality of Life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nutrition Algorithm (NACHO)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition Algorithm
Other Intervention Name(s)
Nutrition Algorithm for Cancer Health Outcomes (NACHO) Program
Intervention Description
A technology-based platform for a person-centered nutrition program, providing suggested foods and recipes from dietitians.
Primary Outcome Measure Information:
Title
Nutrition Algorithm
Description
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
Secondary Outcome Measure Information:
Title
Acceptability of Nutrition Algorithm for Cancer Health Outcomes (NACHO) Program
Description
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
Title
Participant Satisfaction
Description
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
Title
Panel member characteristics (Aims 1a, 1b, 2a, 2b) - Age
Description
Age group (i.e., 18-29, 30-39, 40-49, 50-59, 60-69, 70-79, 80+)
Time Frame
Up to 12 months
Title
Panel member characteristics (Aims 1a, 1b, 2a, 2b) - Gender identity
Description
Gender identity (i.e., female, male, other____, prefer not to answer)
Time Frame
Up to 12 months
Title
Panel member characteristics (Aims 1a, 1b, 2a, 2b) - Ethnicity
Description
Ethnicity (i.e., Hispanic/Latinx / non-Hispanic/non-Latinx, prefer not to answer)
Time Frame
Up to 12 months
Title
Panel member characteristics (Aims 1a, 1b, 2a, 2b) - Race
Description
Race (i.e., Black, Caucasian, Asian, Native American, Pacific Islander, Alaska Native, multiracial, prefer not to answer)
Time Frame
Up to 12 months
Title
Panel member characteristics (Aims 1a, 1b, 2a, 2b) - Position
Description
Position / role and years in position (non-patient panel members only) (fill in)
Time Frame
Up to 12 months
Title
Characteristics of the cohort of 100 patients (Aim 3) - Age
Description
Age group (i.e., 18-29, 30-39, 40-49, 50-59, 60-69, 70-79, 80+)
Time Frame
Up to 12 months
Title
Characteristics of the cohort of 100 patients (Aim 3) - Gender identity
Description
Gender identity (i.e., female, male, other____, prefer not to answer)
Time Frame
Up to 12 months
Title
Characteristics of the cohort of 100 patients (Aim 3) - ethnicity
Description
Ethnicity (i.e., Hispanic/Latinx / non-Hispanic/non-Latinx, prefer not to answer)
Time Frame
Up to 12 months
Title
Characteristics of the cohort of 100 patients (Aim 3) - race
Description
Race (i.e., Black, Caucasian, Asian, Native American, Pacific Islander, Alaska Native, multiracial, prefer not to answer)
Time Frame
Up to 12 months
Title
Characteristics of the cohort of 100 patients (Aim 3) - BMI
Description
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
Title
Characteristics of the cohort of 100 patients (Aim 3) - Comorbidities
Description
Comorbidities: Number of comorbidities (e.g., heart disease, diabetes) will be abstracted from electronic health records
Time Frame
Up to 12 months
Title
Global Health
Description
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
Title
Symptom Questions
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marilyn Hammer, MD
Phone
617-632-1909
Email
MarilynJ_Hammer@dfci.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marilyn Hammer, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Development and Testing of Nutritional Algorithms (NACHO)

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