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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05947357
Other study ID # 64256
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 15, 2023
Est. completion date December 15, 2024

Study information

Verified date March 2024
Source Stanford University
Contact Manali A Patel
Phone 6504859462
Email manalip@stanford.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study seeks to evaluate whether a nutrition assistance quality improvement program for patients with cancer and food insecurity receiving active treatment at Pacific Cancer Care will have reductions in food insecurity.


Description:

This study seeks to evaluate the effectiveness and patient satisfaction with a nutrition assistance quality improvement program in which a randomly selected 30 patients will receive a food voucher with $40.00 each month for 6 months for use in the produce section at local grocery stores in the county. The primary outcome is understanding whether this program is effective at reducing food insecurity among patients being treated for cancer and will provide key insights that may guide program expansion or improvement.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 15, 2024
Est. primary completion date December 15, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Patient Participants must be undergoing or starting treatment for cancer at the Pacific Cancer Care clinic who screen positive for food insecurity using at 2-item screener, speak English or Spanish, have capacity to consent (e.g. no dementia or other cognitive impairment), are Latinx or another racial and ethnic minority group OR low income, have public insurance, OR are insured by an agricultural company sponsored health insurance Exclusion Criteria: - Patients will be ineligible if they do not have a current cancer diagnosis, cannot communicate in English or Spanish, are deemed ineligible to consent, are under 18 years of age, are not Latinx or another racial/ethnic minority OR are not low income OR are not publicly insured, uninsured, or do not have health insurance from an agricultural company

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Nutrition Assistance Program
Patients will receive in the intervention group a $40.00 per month voucher for 6 months for use in the produce section of a local grocery store.

Locations

Country Name City State
United States Stanford University School of Medicine Stanford California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Food Insecurity A validated six-item short form of the Household Food Security Scale will be administered to participants at time of enrollment and again at 6-months post-enrollment. Responses to questions "often" and "sometimes" versus "never" which are considered affirmative responses. Two or more affirmative responses indicate food insecurity, five or more affirmative responses indicates hunger. Baseline to 6 months
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