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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

Intervention / Treatment
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* Other: Interview
* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (interview, survey)<br>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<br>* Attends Interviews<br>Other: Survey Administration<br>* Complete Survey<br>|

What is the study measuring?
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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 |