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

NCT05118802 | Completed

• 3 other identifiers: 21G.671JT 17820080 - 31050 - E269
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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

Interview OTHER

Attends Interviews

Observational (interview, survey)

Survey Administration OTHER

Complete Survey

Observational (interview, survey)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: November 12, 2021
• Study Start: August 11, 2021
• Primary Completion: March 3, 2023
• Study Completion: March 3, 2023
• Last Updated: May 22, 2025

Record last verified: 2025-05

Locations

US (1)