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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05118802
Enrollment
46
Registered
2021-11-12
Start date
2021-08-11
Completion date
2023-03-03
Last updated
2025-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

Brief summary

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.

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.

Interventions

OTHERInterview

Attends Interviews

OTHERSurvey Administration

Complete Survey

Sponsors

Thomas Jefferson University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
identify patient-important outcomes related to receiving nutrition services by engaging patients with cancer and cliniciansAt study completion; approximately 60 minutesReported as average time required to complete each assessment.
UsabilityAt study completion; approximately 60 minutesReported as average time required to complete each assessment.
FeasibilityAt study completion; approximately 60 minutesReported as the number of participants who are able to complete the entire list of assessments to receive nutrition services.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026