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AI-Assisted Whole-Course Management for Medication Safety and Healthcare Burden in Advanced Solid Tumors: A Prospective Controlled Study

2026年11月3日 更新者：Tianjin Medical University Second Hospital

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.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

420

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • 中国
    • Tianjin Municipality
      • Tianjin、Tianjin Municipality、中国、300211
        • 募集
        • Tianjin Medical Unversity Second Hospital
        • 副調査官：
          • Dingkun Hou, Ph.D
        • 副調査官：
          • Jinhuan Wang, Ph.D
        • 副調査官：
          • Lili Wang, Ph.D
        • コンタクト：
        • 副調査官：
          • Hongzheng Li, M.M.
        • コンタクト：
        • 主任研究者：
          • Haitao Wang, Ph.D
      • Tianjin、Tianjin Municipality、中国
        • 募集
        • Department of Oncology, Tianjin Medical University Second Hospital
        • コンタクト：
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

Inclusion Criteria:

  1. Histologically or cytologically confirmed malignant tumor, scheduled to receive or currently receiving systemic anticancer therapy (chemotherapy, targeted therapy, immunotherapy, or endocrine therapy).
  2. Age ≥18 years.
  3. 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.
  4. Expected survival ≥12 months.
  5. Able to understand the study and provide written informed consent.
  6. Receiving regular home oral or cyclic intravenous anticancer treatment and requiring long-term out-of-hospital follow-up.
  7. Able to complete 12 months of follow-up.

Exclusion Criteria:

  1. Pregnant or breastfeeding women.
  2. Severe cognitive impairment or severe psychiatric illness precluding independent follow-up or causing extremely poor adherence.
  3. End-stage multi-organ failure or moribund condition with expected survival <12 months.
  4. Receiving only palliative supportive care, with no planned standard anticancer drug treatment.
  5. Other conditions judged by the investigator as unsuitable for this study.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：支持療法
  • 割り当て：非ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
他の：Oncology Intelligent Management Software

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.
アクティブコンパレータ：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.
他の：Conventional Offline Follow-up Group

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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Incidence of any-grade adverse events
時間枠：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)
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Emergency department visit rate due to anticancer treatment-related adverse events
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Tianjin Medical University Second Hospital

捜査官

  • 主任研究者：Haitao Wang, Ph.D、Tianjin Medical University Second Hospital

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年10月1日

一次修了 (推定)

2027年10月1日

研究の完了 (推定)

2028年8月31日

試験登録日

最初に提出

2026年10月29日

QC基準を満たした最初の提出物

2026年11月3日

最初の投稿 (実際)

2026年11月4日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月4日

QC基準を満たした最後の更新が送信されました

2026年11月3日

最終確認日

2026年11月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • AIM-SAFE

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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