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Identifying Outcome Measures for Assessing Nutritional Interventions Among Cancer Patients

Sponsor
Thomas Jefferson University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05118802
Collaborator
(none)
190
Enrollment
1
Location
22.6
Anticipated Duration (Months)
8.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Interview
  • Other: Survey Administration

Detailed Description

PRIMARY OBJECTIVES:

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

  2. To conduct cognitive interviews to assess comprehension, acceptability, and appropriateness of patient-identified outcomes in aim 1.

  3. 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

Study Type:
Observational
Anticipated Enrollment :
190 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Identifying Outcomes Measures to Evaluate Acute Medical Nutrition Needs and Nutrition Interventions Among Patients With Cancer
Actual Study Start Date :
Aug 11, 2021
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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
Attends Interviews

Other: Survey Administration
Complete Survey

Outcome Measures

Primary Outcome Measures

  1. identify patient-important outcomes related to receiving nutrition services by engaging patients with cancer and clinicians [At study completion; approximately 60 minutes]

    Reported as average time required to complete each assessment.

  2. Usability [At study completion; approximately 60 minutes]

    Reported as average time required to complete each assessment.

  3. Feasibility [At study completion; approximately 60 minutes]

    Reported as the number of participants who are unable to complete the entire list of assessments.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107

Sponsors and Collaborators

  • Thomas Jefferson University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT05118802
Other Study ID Numbers:
  • 21G.671
First Posted:
Nov 12, 2021
Last Update Posted:
Nov 12, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neoplasms

Study Results

No Results Posted as of Nov 12, 2021