AI-Assisted Whole-Course Management for Medication Safety and Healthcare Burden in Advanced Solid Tumors: A Prospective Controlled Study
AI Agent-Enabled Whole-Course Management to Improve Anticancer Medication Safety and Reduce Healthcare Burden in Advanced Solid Tumors: A Prospective, Single-Center, Non-Randomized, Parallel-Group Real-World Controlled Study
This is a prospective, single-center, controlled real-world study in patients with advanced solid tumors (stage III-IV) receiving chemotherapy, targeted therapy, immunotherapy, or endocrine therapy. Participants who choose the digital management group use a smartphone-based oncology management application with medication reminders, AI-assisted laboratory report interpretation, adverse event self-reporting, and clinician alerts for critical values. Participants who choose the conventional group receive routine outpatient follow-up and telephone contact without digital tools. The study follows participants for 12 months to compare the incidence of overall and severe (CTCAE grade ≥3) adverse events, emergency department visits, 30-day readmission, dose reduction, treatment delay/missed doses, and time to adverse event recovery. The aim is to evaluate whether a digital whole-course management model improves medication safety, reduces healthcare burden, and supports treatment adherence in advanced cancer care.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Haitao Wang, Ph.D
- 전화번호: +86-022-88321190
- 이메일: peterrock2000@126.com
연구 연락처 백업
- 이름: Lili Wang, Ph.D
- 전화번호: +86-022-88321185
- 이메일: wangliliaigang@163.com
연구 장소
-
-
Tianjin Municipality
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Tianjin, Tianjin Municipality, 중국, 300211
- 모병
- Tianjin Medical Unversity Second Hospital
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부수사관:
- Dingkun Hou, Ph.D
-
부수사관:
- Jinhuan Wang, Ph.D
-
부수사관:
- Lili Wang, Ph.D
-
연락하다:
- Haitao Wang, Ph.D
- 전화번호: +86-022-88321190
- 이메일: peterrock2000@126.com
-
부수사관:
- Hongzheng Li, M.M.
-
연락하다:
- Lili Wang, Ph.D
- 전화번호: +86-022-88321185
- 이메일: wangliliaigang@163.com
-
수석 연구원:
- Haitao Wang, Ph.D
-
Tianjin, Tianjin Municipality, 중국
- 모병
- Department of Oncology, Tianjin Medical University Second Hospital
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연락하다:
- Lili Wang, Ph.D
- 전화번호: +86-022-88321185
- 이메일: wangliliaigang@163.com
-
연락하다:
- Haitao Wang, Ph.D
- 이메일: wanght@tmu.edu.cn
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Histologically or cytologically confirmed malignant tumor, scheduled to receive or currently receiving systemic anticancer therapy (chemotherapy, targeted therapy, immunotherapy, or endocrine therapy).
- Age ≥18 years.
- For the digital management group: able to independently use a smartphone to scan a QR code to log in, photograph and upload laboratory reports, and complete online forms; for the control group: able to communicate by telephone and attend outpatient visits.
- Expected survival ≥12 months.
- Able to understand the study and provide written informed consent.
- Receiving regular home oral or cyclic intravenous anticancer treatment and requiring long-term out-of-hospital follow-up.
- Able to complete 12 months of follow-up.
Exclusion Criteria:
- Pregnant or breastfeeding women.
- Severe cognitive impairment or severe psychiatric illness precluding independent follow-up or causing extremely poor adherence.
- End-stage multi-organ failure or moribund condition with expected survival <12 months.
- Receiving only palliative supportive care, with no planned standard anticancer drug treatment.
- Other conditions judged by the investigator as unsuitable for this study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Digital Management Group
Participants use a smartphone-based oncology management app for the entire 12-month follow-up: medication check-in with missed-dose reminders; photo upload and AI-assisted interpretation of laboratory reports with critical-value alerts to clinicians; CTCAE 5.0-based adverse event self-reporting with severity-triggered clinician notification; monthly online follow-up questionnaires; and a dedicated module for clinical trial participants. |
A self-developed application integrating medication adherence reminders, AI-assisted laboratory interpretation, adverse event self-reporting, critical-value clinician alerts, monthly electronic follow-up, and clinical trial participant tracking. |
|
활성 비교기: Conventional Follow-up Group
Participants receive routine outpatient follow-up and intermittent telephone contact per standard departmental practice. No digital reminders, no AI-assisted laboratory interpretation, no home-based adverse event self-reporting, and no real-time critical-value alerts. |
The conventional management group reflects routine departmental practice: outpatient appointment-based follow-up, unstructured telephone follow-up, offline review of outside laboratory reports, passive reporting of adverse events at clinic visits or emergency department presentations, and no digital medication adherence reminders or real-time clinician alerts. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence of any-grade adverse events
기간: Within 24 months of enrollment.
|
Proportion of participants experiencing any antineoplastic-related adverse event, graded by NCI CTCAE 5.0. |
Within 24 months of enrollment.
|
|
Incidence of severe adverse events (CTCAE grade ≥3)
기간: Within 24 months of enrollment
|
Proportion of participants experiencing grade ≥3 bone marrow suppression, gastrointestinal events, rash, liver injury, or other CTCAE grade ≥3 events. |
Within 24 months of enrollment
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Emergency department visit rate due to anticancer treatment-related adverse events
기간: 12 months after enrollment
|
Proportion of participants with at least one emergency department visit due to an anticancer treatment-related adverse event during follow-up. Data source: medical records and participant-reported events confirmed by the study site. |
12 months after enrollment
|
|
30-day readmission rate related to anticancer treatment-related adverse events
기간: 12 months after enrollment; each readmission assessed within 30 days after discharge
|
Among participants with at least one hospitalization related to an anticancer treatment-related adverse event, proportion readmitted within 30 days after discharge. Each discharge is followed for 30 days. |
12 months after enrollment; each readmission assessed within 30 days after discharge
|
|
Incidence of anticancer drug dose reduction due to adverse events
기간: 12 months after enrollment
|
Proportion of participants requiring at least one reduction in anticancer drug dose due to an adverse event, as documented in the medical record. |
12 months after enrollment
|
|
Incidence of treatment delay due to adverse events
기간: 12 months after enrollment
|
Proportion of participants with at least one anticancer treatment cycle delayed or temporarily interrupted due to an adverse event. |
12 months after enrollment
|
|
Incidence of missed anticancer doses
기간: 12 months after enrollment
|
Among participants receiving oral anticancer therapy, proportion with at least one missed dose during follow-up, based on app check-in records (intervention group) or self-report/outpatient records (control group). |
12 months after enrollment
|
|
Median time to adverse event recovery
기간: From adverse event onset to recovery, assessed up to 12 months after enrollment
|
Median time from onset of an eligible adverse event to recovery of symptoms and/or laboratory abnormality to baseline or CTCAE grade ≤1, estimated using Kaplan-Meier methods. Adverse events are graded by NCI CTCAE 5.0. |
From adverse event onset to recovery, assessed up to 12 months after enrollment
|
|
Monthly mean number of missed oral anticancer doses
기간: Monthly for 12 months after enrollment
|
Mean number of missed oral anticancer doses per participant per month, calculated from app check-in records (intervention group) or self-report/outpatient records (control group). |
Monthly for 12 months after enrollment
|
|
Protocol adherence rate among clinical trial participants (exploratory)
기간: 12 months after enrollment
|
Among participants concurrently enrolled in a clinical trial, proportion who complete protocol-specified treatment cycles and scheduled assessments without major protocol deviation, as documented by the site. |
12 months after enrollment
|
|
Protocol deviation incidence among clinical trial participants (exploratory)
기간: 12 months after enrollment
|
Among participants concurrently enrolled in a clinical trial, proportion with at least one protocol deviation, classified by type and relationship to the digital management intervention. |
12 months after enrollment
|
공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Haitao Wang, Ph.D, Tianjin Medical University Second Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- AIM-SAFE
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
The study protocol does not include a pre-specified plan or dedicated funding for sharing individual participant data with external researchers. Data will be maintained by the sponsor and participating sites in accordance with the approved informed consent and local regulatory requirements. This statement may be updated if a data sharing plan is established at a later stage.
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. .