Hematopoietic and Lymphoid Cell NeoplasmNCT05118802
Measuring the Impact of MANNA s Medically Tailored Meal Program in Patients With a Non-terminal Cancer Diagnosis
An observational study of Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Interview and Survey Administration
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2021to 3 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Population includes cancer patients at Sidney Kimmel Cancer Center (SKCC), clinicians and MANNA clients.
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
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:
- 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.
- Being tested
- Interview, Survey Administration
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Attends Interviews
Survey AdministrationOther
Complete Survey
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Interview; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At study completion; approximately 60 minutes
Usability
Reported as average time required to complete each assessment.
Measured: 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.
Measured: At study completion; approximately 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2021
- Study start11 Aug 2021
- Primary completion3 Mar 2023
- Study completion3 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118802
- Sponsor's protocol ID
- 21G.671
- Other IDs
- JT 17820, 080 - 31050 - E269
- Status last verified
- May 2025
- First submitted
- 21 Sep 2021
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Impact of MANNA s Medically Tailored Meal Program in Patients With a Non-terminal Cancer Diagnosis
- ClinicalTrials.gov ID
- NCT05118802
- Acronym / sponsor ID
- 21G.671
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 3 Mar 2023 (actual)
- Study completion
- 3 Mar 2023 (actual)
- First posted
- 12 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
PRIMARY OBJECTIVES:
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (interview, survey) | – | Other: Interview, Other: Survey AdministrationPart 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Population includes cancer patients at Sidney Kimmel Cancer Center (SKCC), clinicians and MANNA clients.
Key inclusion criteria (28 listed)
- 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
- AIM 1 PATIENTS: 10 patients have received MANNA services in past 6 months
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewAttends Interviews | Other | Observational (interview, survey) |
| Survey AdministrationComplete Survey | Other | Observational (interview, survey) |
Primary outcome
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.
Usability
Time frame: At study completion; approximately 60 minutes
Reported as average time required to complete each assessment.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
identify patient-important outcomes related to receiving nutrition services by engaging patients with cancer and clinicians (time frame: At study completion; approximately 60 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.