Treatment Adherence
Conditions
Keywords
Treatment Adherence, Food Insecurity, Cancer Patients on Active Treatment
Brief summary
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.
Interventions
OTHERFood Assistance Program
Participants will be enrolled and provided with structured food assistance (e.g., shelf stable food boxes, produce vouchers) for six months
OTHERStandard of Care
Participants who receive usual-care referrals but not food packages.
Sponsors
Virginia Commonwealth University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the impact of a food assistance intervention on treatment adherence and clinical outcomes among food-insecure patients on active treatment. | 6 months following enrollment | Percent of participants that self-report of treatment completion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Food Insecurity Score | Baseline and 6 month follow-up | 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. |
| Change in Quality of Life (QOL) using European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire (EORTC QLQ-30) | Baseline and 6 month follow-up | 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. |
| Change in financial toxicity | Baseline and 6 month follow-up | 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. |
Countries
United States
Contacts
CONTACTMassey CTO CPC Team
PRINCIPAL_INVESTIGATORSusan Hong, MD
Virginia Commonwealth University
Outcome results
None listed