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Completed

NCT Number: NCT05118802

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.

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Key information

Conditions

Hematopoietic and Lymphoid Cell Neoplasm Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Malignant Solid Neoplasm Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

interview

Other

Attends Interviews

Survey Administration

Other

Complete Survey

Primary outcomes

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

    Time frame: At study completion; approximately 60 minutes

    Reported as average time required to complete each assessment.

  2. Usability

    Time frame: At study completion; approximately 60 minutes

    Reported as average time required to complete each assessment.

  3. Feasibility

    Time frame: At study completion; approximately 60 minutes

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

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 12, 2021
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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