Development and Testing of Nutritional Algorithms (NACHO)

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05825469
• Other study ID #: 22-637
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Dana-Farber Cancer Institute
• Contact: Marilyn Hammer, MD
• Phone: 617-632-1909
• Email: MarilynJ_Hammer[@]dfci.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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)

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition
• Nutrition Poor
• Nutritional Deficiency
• Quality of Life

Intervention

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

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Cancer Nutrition Consortium Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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