CancerNCT05947357
Food for Health Equity: Evaluation of a Nutrition Assistance Program
A study testing Nutrition Assistance Program in people with Cancer, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cancer
- What is being tested?
- Nutrition Assistance Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2023to 15 Feb 2025
- Phase
- Interventional
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Addressing LatinX Cancer Care Equity: Food for Health Equity
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.
Read the detailed 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.
- Conditions
- Cancer
- Being tested
- Nutrition Assistance Program
- Keywords
- Food Insecurity, Food Assistance Quality Improvement Program, Latinx and minority patients
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition Assistance ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition Assistance Program | Experimental | A total of 30 Latinx cancer patients on active cancer treatment who have screened positive for food insecurity will receive a $40.00 voucher for use each month for 6 months for nutrition assistance in the produce section of local grocery stores after enrollment in the program. Receives: Other: Nutrition Assistance Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food Insecurity
Assessed using the validated 2-item Hunger Vital Sign, 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. One or more affirmative responses indicate food insecurity.
Measured: Baseline to 6 months
Secondary outcomes (6)
Food Security
Assessed using the validated United States Department of Agriculture (USDA) Six Item Food Security Survey will be administered to participants at time of enrollment and again at 6-months post-enrollment.
Rabbit MP, Hales LJ, Reed-Jones M. Survey Tools. Accessed October 16, 2024, 2024. https://www.ers.usda.gov/topics/food-nutrition-assistance/food-security-in-the-u-s/survey-tools/#six
Measured: Baseline to 6 months
Health-related quality of life (HRQOL)
Assessed using the 27-item validated Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire. The questionnaire has a scale of 0-108, with higher scores correlating with better quality of life.
Cella DF, Tulsky DS, Gray G, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 1993/03// 1993;11(3):570-579. doi:10.1200/jco.1993.11.3.570
Measured: Baseline to 6 months
Financial Toxicity
Assessed using the 12-item Comprehensive Score for Financial Toxicity - Functional Assessment of Chronic Illness Therapy (COST-FACIT) score. Scores range from 0-44 with higher scores correlating with better financial well-being.
de Souza JA, Yap BJ, Wroblewski K, et al. Measuring financial toxicity as a clinically relevant patient-reported outcome: The validation of the COmprehensive Score for financial Toxicity (COST). Cancer. Feb 1 2017;123(3):476-484. doi:10.1002/cncr.30369
Measured: Baseline to 6 months
Health-related social needs
Assessed using the validated 13-item the Accountable Health Communities (AHC) Health-Related Social Needs Screening Tool from the Center for Medicare and Medicaid Services. Each question is scored from 1 to 5, based on the response option, scores are tallied. Totals range from 4 to 20. Higher scores indicate greater health-related social needs.
Measured: Baseline to 6 months
Satisfaction with the intervention
Assessed using a 5-question tool where patients rated their satisfaction with the quality of intervention components and likelihood to recommend it to others. Scores were summed and higher scores indicated greater satisfaction.
Measured: Baseline to 6 months
Treatment Adherence
Using a 1-item dichotomous question on treatment adherence. Adherence to cancer treatment was defined as having no missed scheduled clinic or treatment visits, which was abstracted from the electronic health record.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start15 Jul 2023
- Primary completion15 May 2024
- Study completion15 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients as part of a nutrition assistance program will randomly receive food vouchers for $40.00 each month for use in the produce section of local grocery stores for 6 months.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manali Indravadan Patel, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05947357
- Sponsor's protocol ID
- 64256
- Status last verified
- Mar 2025
- First submitted
- 7 Jul 2023
- Last updated
- 19 Mar 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 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing LatinX Cancer Care Equity: Food for Health Equity
- ClinicalTrials.gov ID
- NCT05947357
- Acronym / sponsor ID
- 64256
- Conditions
- Cancer
- Keywords
- Food Insecurity, Food Assistance Quality Improvement Program, Latinx and minority patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 Feb 2025 (actual)
- First posted
- 17 Jul 2023 (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 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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients as part of a nutrition assistance program will randomly receive food vouchers for $40.00 each month for use in the produce section of local grocery stores for 6 months.
| Arm | Type | Receives |
|---|---|---|
| Nutrition Assistance Program | Experimental | Other: Nutrition Assistance ProgramA total of 30 Latinx cancer patients on active cancer treatment who have screened positive for food insecurity will receive a $40.00 voucher for use each month for 6 months for nutrition assistance in the produce section of local grocery stores after enrollment in the program. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| Nutrition Assistance ProgramPatients 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. | Other | Nutrition Assistance Program |
Primary outcome
Food Insecurity
Time frame: Baseline to 6 months
Assessed using the validated 2-item Hunger Vital Sign, 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. One or more affirmative responses indicate food insecurity.
6 secondary outcomes
Food Security
Time frame: Baseline to 6 months
Health-related quality of life (HRQOL)
Time frame: Baseline to 6 months
Financial Toxicity
Time frame: Baseline to 6 months
Health-related social needs
Time frame: Baseline to 6 months
Satisfaction with the intervention
Time frame: Baseline to 6 months
Treatment Adherence
Time frame: Baseline to 6 months
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 19 Mar 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?
A study testing Nutrition Assistance Program in people with Cancer, run by Stanford 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 1 inclusion and 1 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 19 Mar 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?
Food Insecurity (time frame: Baseline to 6 months). 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 19 Mar 2025.