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CompletedNCT05118802Updated May 22, 2025

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

An observational study in Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, sponsored by Thomas Jefferson University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-22.

Sponsored by Thomas Jefferson University · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
46
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hematopoietic and Lymphoid Cell Neoplasm
  • Malignant Solid Neoplasm

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 46 is below the median of 204 across 1,683 observational studies indexed under Neoplasms.

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Lead sponsor

Thomas Jefferson University is the lead sponsor of 384 studies on the registry; 71 are open to participants now.

Of its 44 completed or terminated interventional studies of FDA-regulated products, 20 (45%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
46 participants (actual)
Patient registry
No

Groups and cohorts

  • 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: Interview · Other: Survey Administration

Interventions

  • OtherInterview

    Attends Interviews

  • OtherSurvey Administration

    Complete Survey

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At study completion; approximately 60 minutes

  2. Usability

    Reported as average time required to complete each assessment.

    Time frame: At study completion; approximately 60 minutes

  3. Feasibility

    Reported as the number of participants who are able to complete the entire list of assessments to receive nutrition services.

    Time frame: At study completion; approximately 60 minutes

07

Study locations

1 site
  • Thomas Jefferson University Hospital
    Philadelphia, Pennsylvania 19107, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05118802
Lead sponsor
Thomas Jefferson University
Responsible party
Sponsor
First posted
Nov 12, 2021
Start date
Aug 11, 2021
Primary completion
Mar 3, 2023
Completion
Mar 3, 2023
Last update
May 22, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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