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PRO-Based Comprehensive Pharmaceutical Management During ICI Therapy: A Randomized Controlled Study

PRO-Based Comprehensive Pharmaceutical Management During ICI Therapy: A Randomized Controlled Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112280
Enrollment
Unknown
Registered
2025-11-12
Start date
2025-08-08
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

malignant tumor

Interventions

Intervention Group:PRO-based comprehensive pharmaceutical care

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed malignant tumors (including both solid tumors and hematologic malignancies), regardless of disease stage, received at least one dose of immune checkpoint inhibitor (ICI) therapy; 2. Aged >=18 years; 3. Any gender; 4. Life expectancy >=3 months; 5. Able to complete electronic or paper-based PRO questionnaires independently or with assistance (e.g., possessing smartphone proficiency or having caregiver support).

Exclusion criteria

Exclusion criteria: 1. Cognitive or language impairments preventing reliable PRO completion (e.g., dementia, aphasia); 2. For participants with neurodegenerative disorders (e.g., Alzheimer’s disease), history of stroke, or psychiatric disorders, when montreal Cognitive Assessment (MoCA) score <=25 will be excluded; 3. Participants with language barriers including inability to communicate in Mandarin Chinese and diagnosed aphasia.

Design outcomes

Primary

MeasureTime frame
Early detection rate of irAEs;

Secondary

MeasureTime frame
Compliance with the Treatment Plan/Regimen;Symptoms burden change;Adherence to Patient-Reported Outcome Questionnaire (PRO) Completion;Quality of Life;

Countries

China

Contacts

Public ContactZhan Mei

West China Hospital of Sichuan University

mandyzhanmei@163.com+86 28 85422096

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026