Measuring the Impact of MANNA s Medically Tailored Meal Program in Patients With a Non-terminal Cancer Diagnosis

This study identifies patient-important outcome measures and develops a survey that assesses the impact of nutritional interventions among cancer patients. Currently, data on the impact of medically tailored meals on outcomes that are meaningful to patients, providers, and payers are limited. For this reason, access to medically tailored meals as a covered benefit for cancer patients is limited. Thus, there is a need to explore the efficacy of nutritional interventions among this population. This study identifies outcome measures for nutritional interventions that are meaningful to patients and providers.

Study Overview

• Status: Completed
• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
• Intervention / Treatment: Other: Survey Administration; Other: Interview

Detailed Description

PRIMARY OBJECTIVES:

I. To identify patient-important outcomes related to receiving nutrition services by engaging patients with cancer and clinicians.

II. To conduct cognitive interviews to assess comprehension, acceptability, and appropriateness of patient-identified outcomes in aim 1.

III. To pilot test the use of the nutrition-related outcome measures identified in aim 1 among a sample of oncology patients.

OUTLINE:

Part I: Patients and clinicians attend semi-structured interviews over 20-30 minutes or cognitive interviews over 60 minutes in support of survey refinement.

Part II: Patients complete survey over 15 minutes.

• Study Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Population includes cancer patients at Sidney Kimmel Cancer Center (SKCC), clinicians and MANNA clients.

Description

Inclusion Criteria:

• AIM 1 PATIENTS: SKCC oncology patients
• AIM 1 PATIENTS: Currently receiving cancer treatment
• AIM 1 PATIENTS: 18 years or older

• AIM 1 PATIENTS: English speaking

  * Pending funding and staff abilities, efforts will be made to include other languages if possible

• AIM 1 PATIENTS: 10 patients have received MANNA services in past 6 months

• AIM 1 PATIENTS: 10 patients currently receiving cancer treatment for curative intent, screen positive for nutrition risk, and report food insecurity

  * Nutrition risk = a score of >= 2 on the Malnutrition Screening Tool, weight loss of 5% over 1 months, or weight loss of > 10% over 6 months

• AIM 1 PATIENTS: 10 patients currently receiving cancer treatment for curative intent, screen positive for nutrition risk, and do not report food insecurity
• AIM 1 CLINICIANS: Providing care/support for oncology patients
• AIM 1 CLINICIANS: English speaking
• AIM 2 PATIENTS: Current SKCC oncology patient
• AIM 2 PATIENTS: 18 years or older

• AIM 2 PATIENTS: English speaking

  • Pending funding and staff abilities, efforts will be made to include other languages if possible
• AIM 2 PATIENTS: 3-5 patients have received MANNA services in past 6 months

• AIM 2 PATIENTS: 3-5 patients currently receiving cancer treatment for curative intent, screen positive for nutrition risk, and report food insecurity

  * Nutrition risk = a score of >= 2 on the Malnutrition Screening Tool, weight loss > 5% over 1 month, or weight loss of > 10% over 6 months

• AIM 2 PATIENTS: 3-5 patients currently receiving cancer treatment for curative intent, screen positive for nutrition risk, and do not report food insecurity
• AIM 3 SKCC PATIENTS: Receiving active cancer treatment for curative intent
• AIM 3 SKCC PATIENTS: Meet MANNA eligibility criteria
• AIM 3 SKCC PATIENTS: Have a phone number or email address for contacting
• AIM 3 SKCC PATIENTS: 18 years or older *Pending funding and staff abilities, efforts will be made to include other languages if possible
• AIM 3 MANNA CLIENTS: Have any cancer diagnosis
• AIM 3 MANNA CLIENTS: Currently receiving MANNA meals
• AIM 3 MANNA CLIENTS: Have a phone number or email address for contacting
• AIM 3 MANNA CLIENTS: 18 years or older
• AIM 3 MANNA CLIENTS: English speaking * Pending funding and staff abilities, efforts will be made to include other languages if possible

Exclusion Criteria:

• AIM 1 PATIENTS: Unable to provide consent (as assessed by team member conducting enrollment, with use of teachback)
• AIM 1 PATIENTS: Lives in a facility that provides nutrition services (e.g., nursing home, rehab facility, incarcerated, emergency shelter)
• AIM 1 PATIENTS: Homelessness
• AIM 1 CLINICIANS: Unable to provide consent (as assessed by team member conducting enrollment, with use of teachback)
• AIM 2 PATIENTS: Unable to provide consent (as assessed by team member conducting enrollment, with use of teachback)
• AIM 2 PATIENTS: Lives in a facility that provides nutrition services (e.g., nursing home, rehab facility, incarcerated, emergency shelter)
• AIM 2 PATIENTS: Homelessness
• AIM 3 SKCC PATIENTS: Unable to provide consent (as assessed by team member conducting enrollment, with use of teachback)
• AIM 3 SKCC PATIENTS: Lives in a facility that provides nutrition services (e.g., nursing home, rehab facility, incarcerated, emergency shelter)
• AIM 3 SKCC PATIENTS: Homelessness
• AIM 3 MANNA CLIENTS: Unable to provide consent (as assessed by team members conducting enrollment, with use of teachback)
• AIM 3 MANNA CLIENTS: Homelessness

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational (interview, survey); Part I: Patients and clinicians attend semi-structured interviews over 20-30 minutes or cognitive interviews over 60 minutes in support of survey refinement. Part II: Patients complete survey over 15 minutes.	Other: Survey Administration; Complete Survey; Other: Interview; Attends Interviews

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
identify patient-important outcomes related to receiving nutrition services by engaging patients with cancer and clinicians	Reported as average time required to complete each assessment.	At study completion; approximately 60 minutes
Usability	Reported as average time required to complete each assessment.	At study completion; approximately 60 minutes
Feasibility	Reported as the number of participants who are able to complete the entire list of assessments to receive nutrition services.	At study completion; approximately 60 minutes

Collaborators and Investigators

• Sponsor: Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2021
• Primary Completion (Actual): March 3, 2023
• Study Completion (Actual): March 3, 2023

Study Registration Dates

• First Submitted: September 21, 2021
• First Submitted That Met QC Criteria: November 11, 2021
• First Posted (Actual): November 12, 2021

Study Record Updates

• Last Update Posted (Actual): May 22, 2025
• Last Update Submitted That Met QC Criteria: May 19, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 21G.671; JT 17820 (Other Identifier: JeffTrial Number); 080 - 31050 - E269 (Other Grant/Funding Number: MANNA Institute)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No