Digital HealthNCT07917351
AI-Assisted Whole-Course Management for Medication Safety and Healthcare Burden in Advanced Solid Tumors: A Prospective Controlled Study
A study testing Oncology Intelligent Management Software and Conventional Offline Follow-up Group in people with Digital Health and Artificial Intelligence (AI), run by Tianjin Medical University Second Hospital at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Digital Health, Artificial Intelligence (AI)
- What is being tested?
- Oncology Intelligent Management Software and Conventional Offline Follow-up Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 2 sitesChina
- Study dates
- 1 Oct 2026to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Tianjin Medical Unversity Second Hospital
Tianjin, Tianjin Municipality, 300211
Haitao Wang, Ph.D, +86-022-88321190, peterrock2000@126.com
Lili Wang, Ph.D, +86-022-88321185, wangliliaigang@163.com
- Recruiting
Department of Oncology, Tianjin Medical University Second Hospital
Tianjin, Tianjin Municipality
Haitao Wang, Ph.D, wanght@tmu.edu.cn
Lili Wang, Ph.D, +86-022-88321185, wangliliaigang@163.com
About this study
Official title: 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.
- Conditions
- Digital Health, Artificial Intelligence (AI)
- Being tested
- Oncology Intelligent Management Software, Conventional Offline Follow-up Group
- Keywords
- Digital health, Artificial Intelligence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oncology Intelligent Management SoftwareOther
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.
Conventional Offline Follow-up GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Digital Management Group | Experimental | 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. Receives: Other: Oncology Intelligent Management Software |
| Conventional Follow-up Group | Active comparator | 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. Receives: Other: Conventional Offline Follow-up Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of any-grade adverse events
Proportion of participants experiencing any antineoplastic-related adverse event, graded by NCI CTCAE 5.0.
Measured: Within 24 months of enrollment.
Incidence of severe adverse events (CTCAE grade ≥3)
Proportion of participants experiencing grade ≥3 bone marrow suppression, gastrointestinal events, rash, liver injury, or other CTCAE grade ≥3 events.
Measured: Within 24 months of enrollment
Secondary outcomes (9)
Emergency department visit rate due to anticancer treatment-related adverse events
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.
Measured: 12 months after enrollment
30-day readmission rate related to anticancer treatment-related adverse events
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.
Measured: 12 months after enrollment; each readmission assessed within 30 days after discharge
Incidence of anticancer drug dose reduction due to adverse events
Proportion of participants requiring at least one reduction in anticancer drug dose due to an adverse event, as documented in the medical record.
Measured: 12 months after enrollment
Incidence of treatment delay due to adverse events
Proportion of participants with at least one anticancer treatment cycle delayed or temporarily interrupted due to an adverse event.
Measured: 12 months after enrollment
Incidence of missed anticancer doses
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).
Measured: 12 months after enrollment
Median time to adverse event recovery
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.
Measured: From adverse event onset to recovery, assessed up to 12 months after enrollment
Monthly mean number of missed oral anticancer doses
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).
Measured: Monthly for 12 months after enrollment
Protocol adherence rate among clinical trial participants (exploratory)
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.
Measured: 12 months after enrollment
Protocol deviation incidence among clinical trial participants (exploratory)
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.
Measured: 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Oct 2026
- Primary completion1 Oct 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digital HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Second Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haitao Wang, Ph.D, Principal investigator, Tianjin Medical University Second Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917351
- Sponsor's protocol ID
- AIM-SAFE
- Status last verified
- Nov 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07917351
- Acronym / sponsor ID
- AIM-SAFE
- Conditions
- Digital Health, Artificial Intelligence (AI)
- Keywords
- Digital health, Artificial Intelligence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Tianjin Medical University Second HospitalUniversity, hospital or other
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Management Group | Experimental | Other: Oncology Intelligent Management SoftwareParticipants 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. |
| Conventional Follow-up Group | Active comparator | Other: Conventional Offline Follow-up GroupParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oncology Intelligent Management SoftwareA 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. | Other | Digital Management Group |
| Conventional Offline Follow-up GroupThe 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. | Other | Conventional Follow-up Group |
Primary outcome
Incidence of any-grade adverse events
Time frame: Within 24 months of enrollment.
Proportion of participants experiencing any antineoplastic-related adverse event, graded by NCI CTCAE 5.0.
Incidence of severe adverse events (CTCAE grade ≥3)
Time frame: 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.
9 secondary outcomes
Emergency department visit rate due to anticancer treatment-related adverse events
Time frame: 12 months after enrollment
30-day readmission rate related to anticancer treatment-related adverse events
Time frame: 12 months after enrollment; each readmission assessed within 30 days after discharge
Incidence of anticancer drug dose reduction due to adverse events
Time frame: 12 months after enrollment
Incidence of treatment delay due to adverse events
Time frame: 12 months after enrollment
Incidence of missed anticancer doses
Time frame: 12 months after enrollment
Median time to adverse event recovery
Time frame: From adverse event onset to recovery, assessed up to 12 months after enrollment
Monthly mean number of missed oral anticancer doses
Time frame: Monthly for 12 months after enrollment
Protocol adherence rate among clinical trial participants (exploratory)
Time frame: 12 months after enrollment
Protocol deviation incidence among clinical trial participants (exploratory)
Time frame: 12 months after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Haitao Wang, Ph.D principal investigator
Tianjin Medical University Second Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oncology Intelligent Management Software and Conventional Offline Follow-up Group in people with Digital Health and Artificial Intelligence (AI), run by Tianjin Medical University Second Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haitao Wang, Ph.D (+86-022-88321190, peterrock2000@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of any-grade adverse events (time frame: Within 24 months of enrollment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.