Treatment AdherenceNCT07706192
Impact of Food Assistance on Treatment Adherence and Clinical Outcomes in Food-Insecure Cancer Pts
A study testing Food Assistance Program in people with Treatment Adherence, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
Prospective cohort and descriptive study aimed at identifying cancer patients experiencing food insecurity at Virginia Commonwealth University (VCU) Massey Comprehensive Cancer Center. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment Adherence
- What is being tested?
- Food Assistance Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2026to 31 Aug 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥18 years old) with a current diagnosis of cancer
- Patients attending outpatient services at the VCU Massey Comprehensive Cancer Center
- Patients who are willing to participate and provide informed consent
- Responding "sometimes true" or "often true" to at least one of the two validate Hunger Vital Sign Screening questions
Who cannot join
- Patients who are unable to provide informed consent due to cognitive impairment or language barriers
- Patients who are enrolled in other clinical trials that prohibit participation in additional research
- Patients who do not consent to being included in the food insecurity registry
- Patients with medical conditions other than cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23286
Massey CTO CPC Team, 804-628-6430, MasseyCPC@vcu.edu
Susan Hong, MD
About this study
Official title: Impact of Food Assistance on Treatment Adherence and Clinical Outcomes in Food-Insecure Cancer Patients Undergoing Active Treatment
Prospective cohort and descriptive study aimed at identifying cancer patients experiencing food insecurity at Virginia Commonwealth University (VCU) Massey Comprehensive Cancer Center. The study will involve evaluating the impact of a food assistance intervention on treatment adherence and clinical outcomes among food-insecure patients on active treatment.
- Conditions
- Treatment Adherence
- Being tested
- Food Assistance Program, Standard of Care
- Keywords
- Treatment Adherence, Food Insecurity, Cancer Patients on Active Treatment
- Medical subject headings
- Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food Assistance ProgramOther
Also called Intervention Cohort
Participants will be enrolled and provided with structured food assistance (e.g., shelf stable food boxes, produce vouchers) for six months
Standard of CareOther
Also called Comparison Cohort
Participants who receive usual-care referrals but not food packages.
| Study group | Role | What they receive |
|---|---|---|
| Food Assistance Program | Experimental | Six month food assistance program-shelf-stable food boxes Receives: Other: Food Assistance Program |
| Standard of Care | Active comparator | Usual-care referrals Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the impact of a food assistance intervention on treatment adherence and clinical outcomes among food-insecure patients on active treatment.
Percent of participants that self-report of treatment completion
Measured: 6 months following enrollment
Secondary outcomes (3)
Change in Food Insecurity Score
Using the Food Insecurity Assessment: a 2 Question Hunger Vital Signs will be used to assess patient food insecurity status with the following two questions:
"Within the past 12 months, did you worry your food would run out before you got the money to buy more?" "Within the past 12 months, did the food you buy not last and you didn't have money to get more?"
Scoring will categorize patients as never true, sometimes true, or often true. Baseline is defined as when a patient responds SOMETIMES TRUE or OFTEN TRUE to one of the two validated Hunger Vital Sign Screening questions for the first time. Patients will receive an email about the financial impact and QOL validated surveys at each time interval.
Measured: Baseline and 6 month follow-up
Change in Quality of Life (QOL) using European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire (EORTC QLQ-30)
The EORTC QLQ-30 questionnaire is a 30-item, patient-reported instrument designed to assess the health-related quality of life (HRQoL), functional status, and symptom burden of cancer patients. Comprises 30 questions grouped into 5 functional scales, 9 symptom scales/items, and a global health status.
Scoring: Uses a 4-point Likert scale (7-point for global items), transformed to a 0-100 scale. Higher scores indicate better function/QoL, but worse symptom burden.
Measured: Baseline and 6 month follow-up
Change in financial toxicity
The Functional Assessment of Chronic Illness Therapy for measure of financial toxicity (FACIT-COST) questionnaire to assess the impact of treatment on patient financial status. This measure has 12 questions based on patient reported outcomes to assess financial quality of life stress; numeric responses 0-4; Uses a score range 0-44 with higher scores indicating better Financial Well-Being.
Measured: Baseline and 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start6 Jul 2026
- Primary completion31 Aug 2035 (estimated)
- Study completion31 Aug 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment AdherenceStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Hong, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706192
- Sponsor's protocol ID
- MCC-25-22644
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no current plans to share individual patient data.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Food Assistance on Treatment Adherence and Clinical Outcomes in Food-Insecure Cancer Patients Undergoing Active Treatment
- ClinicalTrials.gov ID
- NCT07706192
- Acronym / sponsor ID
- MCC-25-22644
- Conditions
- Treatment Adherence
- Keywords
- Treatment Adherence, Food Insecurity, Cancer Patients on Active Treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 6 Jul 2026 (actual)
- Primary completion
- 31 Aug 2035 (estimated)
- Study completion
- 31 Aug 2035 (estimated)
- First posted
- 15 Jul 2026 (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.
Prospective cohort and descriptive study aimed at identifying cancer patients experiencing food insecurity at Virginia Commonwealth University (VCU) Massey Comprehensive Cancer Center. The study will involve evaluating the impact of a food assistance intervention on treatment adherence and clinical outcomes among food-insecure patients on active treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Food Assistance Program | Experimental | Other: Food Assistance ProgramSix month food assistance program-shelf-stable food boxes |
| Standard of Care | Active comparator | Other: Standard of CareUsual-care referrals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (≥18 years old) with a current diagnosis of cancer
- Patients attending outpatient services at the VCU Massey Comprehensive Cancer Center
- Patients who are willing to participate and provide informed consent
- Responding "sometimes true" or "often true" to at least one of the two validate Hunger Vital Sign Screening questions
Key exclusion criteria (4 listed)
- Patients who are unable to provide informed consent due to cognitive impairment or language barriers
- Patients who are enrolled in other clinical trials that prohibit participation in additional research
- Patients who do not consent to being included in the food insecurity registry
- Patients with medical conditions other than cancer
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 |
|---|---|---|
| Food Assistance ProgramAlso: Intervention CohortParticipants will be enrolled and provided with structured food assistance (e.g., shelf stable food boxes, produce vouchers) for six months | Other | Food Assistance Program |
| Standard of CareAlso: Comparison CohortParticipants who receive usual-care referrals but not food packages. | Other | Standard of Care |
Primary outcome
Evaluate the impact of a food assistance intervention on treatment adherence and clinical outcomes among food-insecure patients on active treatment.
Time frame: 6 months following enrollment
Percent of participants that self-report of treatment completion
3 secondary outcomes
Change in Food Insecurity Score
Time frame: Baseline and 6 month follow-up
Change in Quality of Life (QOL) using European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire (EORTC QLQ-30)
Time frame: Baseline and 6 month follow-up
Change in financial toxicity
Time frame: Baseline and 6 month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No. There are no current plans to share individual patient data.
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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.
Susan Hong, MD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food Assistance Program in people with Treatment Adherence, run by Virginia Commonwealth 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 15 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Massey CTO CPC Team (804-628-6430, MasseyCPC@vcu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the impact of a food assistance intervention on treatment adherence and clinical outcomes among food-insecure patients on active treatment. (time frame: 6 months following enrollment). 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 15 Jul 2026.