[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07706192":3,"trial-entities:NCT07706192":101,"trial-summary:NCT07706192":105},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":43,"secondary_outcomes":48,"sex":59,"minimum_age":60,"maximum_age":17,"healthy_volunteers":61,"eligibility_criteria":62,"std_ages":74,"locations":77,"central_contacts":95,"overall_officials":97,"references":99,"see_also_links":100},"NCT07706192","MCC-25-22644","Impact of Food Assistance on Treatment Adherence and Clinical Outcomes in Food-Insecure Cancer Pts","Impact of Food Assistance on Treatment Adherence and Clinical Outcomes in Food-Insecure Cancer Patients Undergoing Active Treatment","RECRUITING","2035-08-31","2026-07","2026-07-15","2026-07-06","Virginia Commonwealth University","OTHER",true,"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.",null,[19],"Treatment Adherence",[19,21,22],"Food Insecurity","Cancer Patients on Active Treatment","INTERVENTIONAL","SUPPORTIVE_CARE",[26],"NA",{"count":28,"type":29},350,"ESTIMATED",[31,37],{"type":14,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Food Assistance Program","Participants will be enrolled and provided with structured food assistance (e.g., shelf stable food boxes, produce vouchers) for six months",[32],[36],"Intervention Cohort",{"type":14,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Standard of Care","Participants who receive usual-care referrals but not food packages.",[38],[42],"Comparison Cohort",[44],{"measure":45,"description":46,"timeFrame":47},"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",[49,53,56],{"measure":50,"description":51,"timeFrame":52},"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:\n\n\"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?\"\n\nScoring 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.","Baseline and 6 month follow-up",{"measure":54,"description":55,"timeFrame":52},"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\u002Fitems, and a global health status.\n\nScoring: Uses a 4-point Likert scale (7-point for global items), transformed to a 0-100 scale. Higher scores indicate better function\u002FQoL, but worse symptom burden.",{"measure":57,"description":58,"timeFrame":52},"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.","ALL","18 Years",false,{"inclusion":63,"exclusion":68,"raw_text":73},[64,65,66,67],"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",[69,70,71,72],"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","Inclusion Criteria:\n\n* Adult patients (≥18 years old) with a current diagnosis of cancer\n* Patients attending outpatient services at the VCU Massey Comprehensive Cancer Center\n* Patients who are willing to participate and provide informed consent\n* Responding \"sometimes true\" or \"often true\" to at least one of the two validate Hunger Vital Sign Screening questions\n\nExclusion Criteria:\n\n* Patients who are unable to provide informed consent due to cognitive impairment or language barriers\n* Patients who are enrolled in other clinical trials that prohibit participation in additional research\n* Patients who do not consent to being included in the food insecurity registry\n* Patients with medical conditions other than cancer",[75,76],"ADULT","OLDER_ADULT",[78],{"facility":13,"status":8,"city":79,"state":80,"zip":81,"country":82,"contacts":83,"geoPoint":92},"Richmond","Virginia","23286","United States",[84,89],{"name":85,"role":86,"phone":87,"email":88},"Massey CTO CPC Team","CONTACT","804-628-6430","MasseyCPC@vcu.edu",{"name":90,"role":91},"Susan Hong, MD","PRINCIPAL_INVESTIGATOR",{"lat":93,"lon":94},37.55376,-77.46026,[96],{"name":85,"role":86,"phone":87,"email":88},[98],{"name":90,"affiliation":13,"role":91},[],[],{"nct_id":4,"conditions":102,"biomarkers":104},[103],"Malignant Neoplasm",[],{"nct_id":4,"found":15,"summary":106,"prompt_version":116},{"design":107,"status":108,"heading":109,"summary":110,"follow_up":111,"word_count":112,"commitments":113,"compensation":114,"drugs_mentioned":115},"This is a study that will enroll 350 participants. It compares a group receiving food assistance to a group receiving standard care.","completed","Food Assistance for Cancer Patients Study","This study is looking at how providing food assistance impacts cancer patients who are struggling to get enough food. It aims to see if receiving structured food assistance, like shelf-stable food boxes or produce vouchers, helps patients stick to their cancer treatments and improves their health outcomes. You might be able to join if you are an adult (18 or older) with a cancer diagnosis, receive outpatient care at VCU Massey Comprehensive Cancer Center, and answer \"sometimes true\" or \"often true\" to questions about food insecurity. The study will compare patients who receive food assistance for six months to those who receive usual care referrals without food packages. The main goal is to understand the effects of food assistance on treatment adherence and overall health after six months.","The primary outcomes will be measured at 6 months following enrollment.",128,"Participants receiving food assistance will receive structured food assistance for six months. The study will measure outcomes at 6 months following enrollment.","Not stated in the trial record.",[],"v2"]