Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT05118802
Status:
COMPLETED
Last Update Posted:
2025-05-22
First Post:
2021-09-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Measuring the Impact of MANNA s Medically Tailored Meal Program in Patients With a Non-terminal Cancer Diagnosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007407', 'term': 'Interviews as Topic'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-19', 'studyFirstSubmitDate': '2021-09-21', 'studyFirstSubmitQcDate': '2021-11-11', 'lastUpdatePostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'identify patient-important outcomes related to receiving nutrition services by engaging patients with cancer and clinicians', 'timeFrame': 'At study completion; approximately 60 minutes', 'description': 'Reported as average time required to complete each assessment.'}, {'measure': 'Usability', 'timeFrame': 'At study completion; approximately 60 minutes', 'description': 'Reported as average time required to complete each assessment.'}, {'measure': 'Feasibility', 'timeFrame': 'At study completion; approximately 60 minutes', 'description': 'Reported as the number of participants who are able to complete the entire list of assessments to receive nutrition services.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hematopoietic and Lymphoid Cell Neoplasm', 'Malignant Solid Neoplasm']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To identify patient-important outcomes related to receiving nutrition services by engaging patients with cancer and clinicians.\n\nII. To conduct cognitive interviews to assess comprehension, acceptability, and appropriateness of patient-identified outcomes in aim 1.\n\nIII. To pilot test the use of the nutrition-related outcome measures identified in aim 1 among a sample of oncology patients.\n\nOUTLINE:\n\nPart I: Patients and clinicians attend semi-structured interviews over 20-30 minutes or cognitive interviews over 60 minutes in support of survey refinement.\n\nPart II: Patients complete survey over 15 minutes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Population includes cancer patients at Sidney Kimmel Cancer Center (SKCC), clinicians and MANNA clients.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* AIM 1 PATIENTS: SKCC oncology patients\n* AIM 1 PATIENTS: Currently receiving cancer treatment\n* AIM 1 PATIENTS: 18 years or older\n* AIM 1 PATIENTS: English speaking\n\n \\* Pending funding and staff abilities, efforts will be made to include other languages if possible\n* AIM 1 PATIENTS: 10 patients have received MANNA services in past 6 months\n* AIM 1 PATIENTS: 10 patients currently receiving cancer treatment for curative intent, screen positive for nutrition risk, and report food insecurity\n\n \\* 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\n* AIM 1 PATIENTS: 10 patients currently receiving cancer treatment for curative intent, screen positive for nutrition risk, and do not report food insecurity\n* AIM 1 CLINICIANS: Providing care/support for oncology patients\n* AIM 1 CLINICIANS: English speaking\n* AIM 2 PATIENTS: Current SKCC oncology patient\n* AIM 2 PATIENTS: 18 years or older\n* AIM 2 PATIENTS: English speaking\n\n * Pending funding and staff abilities, efforts will be made to include other languages if possible\n* AIM 2 PATIENTS: 3-5 patients have received MANNA services in past 6 months\n* AIM 2 PATIENTS: 3-5 patients currently receiving cancer treatment for curative intent, screen positive for nutrition risk, and report food insecurity\n\n \\* 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\n* AIM 2 PATIENTS: 3-5 patients currently receiving cancer treatment for curative intent, screen positive for nutrition risk, and do not report food insecurity\n* AIM 3 SKCC PATIENTS: Receiving active cancer treatment for curative intent\n* AIM 3 SKCC PATIENTS: Meet MANNA eligibility criteria\n* AIM 3 SKCC PATIENTS: Have a phone number or email address for contacting\n* AIM 3 SKCC PATIENTS: 18 years or older \\*Pending funding and staff abilities, efforts will be made to include other languages if possible\n* AIM 3 MANNA CLIENTS: Have any cancer diagnosis\n* AIM 3 MANNA CLIENTS: Currently receiving MANNA meals\n* AIM 3 MANNA CLIENTS: Have a phone number or email address for contacting\n* AIM 3 MANNA CLIENTS: 18 years or older\n* AIM 3 MANNA CLIENTS: English speaking \\* Pending funding and staff abilities, efforts will be made to include other languages if possible\n\nExclusion Criteria:\n\n* AIM 1 PATIENTS: Unable to provide consent (as assessed by team member conducting enrollment, with use of teachback)\n* AIM 1 PATIENTS: Lives in a facility that provides nutrition services (e.g., nursing home, rehab facility, incarcerated, emergency shelter)\n* AIM 1 PATIENTS: Homelessness\n* AIM 1 CLINICIANS: Unable to provide consent (as assessed by team member conducting enrollment, with use of teachback)\n* AIM 2 PATIENTS: Unable to provide consent (as assessed by team member conducting enrollment, with use of teachback)\n* AIM 2 PATIENTS: Lives in a facility that provides nutrition services (e.g., nursing home, rehab facility, incarcerated, emergency shelter)\n* AIM 2 PATIENTS: Homelessness\n* AIM 3 SKCC PATIENTS: Unable to provide consent (as assessed by team member conducting enrollment, with use of teachback)\n* AIM 3 SKCC PATIENTS: Lives in a facility that provides nutrition services (e.g., nursing home, rehab facility, incarcerated, emergency shelter)\n* AIM 3 SKCC PATIENTS: Homelessness\n* AIM 3 MANNA CLIENTS: Unable to provide consent (as assessed by team members conducting enrollment, with use of teachback)\n* AIM 3 MANNA CLIENTS: Homelessness'}, 'identificationModule': {'nctId': 'NCT05118802', 'briefTitle': 'Measuring the Impact of MANNA s Medically Tailored Meal Program in Patients With a Non-terminal Cancer Diagnosis', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'Measuring the Impact of MANNA s Medically Tailored Meal Program in Patients With a Non-terminal Cancer Diagnosis', 'orgStudyIdInfo': {'id': '21G.671'}, 'secondaryIdInfos': [{'id': 'JT 17820', 'type': 'OTHER', 'domain': 'JeffTrial Number'}, {'id': '080 - 31050 - E269', 'type': 'OTHER_GRANT', 'domain': 'MANNA Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational (interview, survey)', 'description': 'Part I: Patients and clinicians attend semi-structured interviews over 20-30 minutes or cognitive interviews over 60 minutes in support of survey refinement.\n\nPart II: Patients complete survey over 15 minutes.', 'interventionNames': ['Other: Interview', 'Other: Survey Administration']}], 'interventions': [{'name': 'Interview', 'type': 'OTHER', 'description': 'Attends Interviews', 'armGroupLabels': ['Observational (interview, survey)']}, {'name': 'Survey Administration', 'type': 'OTHER', 'description': 'Complete Survey', 'armGroupLabels': ['Observational (interview, survey)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}