Clinical trial NCT05825469: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nutrition Poor
Nutritional Deficiency
Quality of Life
Keywords: Poor Nutrition
Nutritional Deficiency
Quality of Life
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Cancer Nutrition Consortium Inc.
First posted: 2023-04-24
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Nutrition Algorithm
timeFrame: 12 months
Secondary outcomes:
measure: Acceptability of Nutrition Algorithm for Cancer Health Outcomes (NACHO) Program
timeFrame: Up to 8 months
measure: Participant Satisfaction
timeFrame: Up to 8 months
measure: Panel member characteristics (Aims 1a, 1b, 2a, 2b) - Age
timeFrame: Up to 12 months
measure: Panel member characteristics (Aims 1a, 1b, 2a, 2b) - Gender identity
timeFrame: Up to 12 months
measure: Panel member characteristics (Aims 1a, 1b, 2a, 2b) - Ethnicity
timeFrame: Up to 12 months
measure: Panel member characteristics (Aims 1a, 1b, 2a, 2b) - Race
timeFrame: Up to 12 months
measure: Panel member characteristics (Aims 1a, 1b, 2a, 2b) - Position
timeFrame: Up to 12 months
measure: Characteristics of the cohort of 100 patients (Aim 3) - Age
timeFrame: Up to 12 months
measure: Characteristics of the cohort of 100 patients (Aim 3) - Gender identity
timeFrame: Up to 12 months
measure: Characteristics of the cohort of 100 patients (Aim 3) - ethnicity
timeFrame: Up to 12 months
measure: Characteristics of the cohort of 100 patients (Aim 3) - race
timeFrame: Up to 12 months
measure: Characteristics of the cohort of 100 patients (Aim 3) - BMI
timeFrame: Up to 12 months
measure: Characteristics of the cohort of 100 patients (Aim 3) - Comorbidities
timeFrame: Up to 12 months
measure: Global Health
timeFrame: Up to 12 months
measure: Symptom Questions
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Marilyn Hammer, MD
role: PRINCIPAL_INVESTIGATOR
References: