- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06760754
Examining the Feasibility and Impact of a Clinic-based Food Farmacy and Digital Culinary Medicine Program Among Cancer Survivors Treated in a Safety Net Hospital
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Primary Objective:
Determine the feasibility of study recruitment goal, intervention adherence rate, attrition rate, data completion rate, and program satisfaction rate.
Secondary Objective:
Assess the preliminary efficacy of the digital culinary medicine intervention to improve diet quality, food security, quality of life, and downstream biological indicators of cardiometabolic health from baseline to post-intervention, as well as from baseline to 6 month follow up, among food insecure cancer survivors.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Maria Vazquez
- Phone Number: 713-792-7124
- Email: mrvazquez1@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- The University of Texas M. D. Anderson Cancer Center
-
Contact:
- Maria Vazquez
- Phone Number: 713-792-7124
- Email: mrvazquez1@mdanderson.org
-
Principal Investigator:
- Margaret Raber, DRPH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Cancer survivors treated at the MD Anderson Oncology Program at LBJ Hospital over 18 years of age.
- Screen positive for food insecurity using the 2 question clinic-screener (Hunger Vital Signs)
- Receive referral to the LBJ Food Farmacy.
- Are within the first 5 years off of acute cancer treatment.
- Self-report having internet access.
- Self-report as being able to speak and read English or Spanish.
- Willing to complete study assessments.
Exclusion Criteria:
- Unwilling or unable to complete study assessments
- Anyone under 18 years of age
- Self-report to not speak or read English or Spanish
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Usual Care Waitlist Control
Participants will be assessed for study eligibility and randomized to study
|
Participants will receive 30lbs of healthy foods through an on-site hospital-base food pantry
|
|
Experimental: Intervention Group
Participants will be assessed for study eligibility and randomized to study
|
Participants will receive 30lbs of healthy foods through an on-site hospital-base food pantry
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Safety and Adverse Events (AEs)
Time Frame: Through study completion; an average of 1 year
|
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
|
Through study completion; an average of 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Margaret Raber, DRPH, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-1732
- NCI-2024-10265 (Other Identifier: NCI-CTRP Clinical Trials Registry)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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