Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Food Assistance Program | Experimental | Six month food assistance program-shelf-stable food boxes |
|
| Standard of Care | Active Comparator | Usual-care referrals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Food Assistance Program | Other | Participants will be enrolled and provided with structured food assistance (e.g., shelf stable food boxes, produce vouchers) for six months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months following enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Massey CTO CPC Team | Contact | 804-628-6430 | MasseyCPC@vcu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Susan Hong, MD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Recruiting | Richmond | Virginia | 23286 | United States |
There are no current plans to share individual patient data.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D063105 | Food Assistance |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D011632 | Public Assistance |
| D005380 | Financing, Government |
| D005381 | Financing, Organized |
| D004467 | Economics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Standard of Care | Other | Participants who receive usual-care referrals but not food packages. |
|
|
| 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. | 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. | Baseline and 6 month follow-up |
| D004472 |
| Health Care Economics and Organizations |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |