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
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Massey CTO CPC Team
- 전화번호: 804-628-6430
- 이메일: MasseyCPC@vcu.edu
연구 장소
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Virginia
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Richmond, Virginia, 미국, 23286
- 모병
- Virginia Commonwealth University
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수석 연구원:
- Susan Hong, MD
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연락하다:
- Massey CTO CPC Team
- 전화번호: 804-628-6430
- 이메일: MasseyCPC@vcu.edu
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Food Assistance Program
Six month food assistance program-shelf-stable food boxes
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Participants will be enrolled and provided with structured food assistance (e.g., shelf stable food boxes, produce vouchers) for six months
다른 이름들:
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활성 비교기: Standard of Care
Usual-care referrals
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Participants who receive usual-care referrals but not food packages.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Evaluate the impact of a food assistance intervention on treatment adherence and clinical outcomes among food-insecure patients on active treatment.
기간: 6 months following enrollment
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Percent of participants that self-report of treatment completion
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6 months following enrollment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Food Insecurity Score
기간: Baseline and 6 month follow-up
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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. |
Baseline and 6 month follow-up
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Change in Quality of Life (QOL) using European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire (EORTC QLQ-30)
기간: Baseline and 6 month follow-up
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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
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Change in financial toxicity
기간: Baseline and 6 month follow-up
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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.
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Baseline and 6 month follow-up
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공동 작업자 및 조사자
수사관
- 수석 연구원: Susan Hong, MD, Virginia Commonwealth University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- MCC-25-22644
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Food Assistance Program에 대한 임상 시험
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Children's Hospital Medical Center, CincinnatiNational Institute of Mental Health (NIMH)완전한
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International Centre for Diarrhoeal Disease Research...Washington University School of Medicine모병
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Purdue University완전한
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Montefiore Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)완전한
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The Hospital for Sick ChildrenRyerson University모병
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Chang Gung University of Science and Technology아직 모집하지 않음
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AdventHealthState of Florida Department of Health모병
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Ohio State UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)모병