Development of a Cloud-Based PRO (Patient-Reported Outcome) Management Program for Home-Based Cancer Pain Care

4th Affiliated Hospital, School of Medicine, Zhejiang University, China

This study aims to develop and pilot a cloud-based Patient-Reported Outcomes (PROs) management program for home-based cancer pain patients within a hospital setting. It is expected to serve as a reference for improving pain management in home-based cancer care and to provide insights for future related research as well as the broader application and dissemination of the program.

Study Overview

• Status: Withdrawn
• Conditions: Cancer Pain
• Intervention / Treatment: Other: Proactive monitoring and patient education

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Yiwu, Zhejiang, China, 32200-
      • 4th Affiliated Hospital, School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Aged 18 years or older; Pathologically confirmed diagnosis of cancer with concomitant pain requiring analgesic medication; Alert and oriented, free of psychiatric disorders or cognitive impairment; Adequate comprehension, essentially normal vision and hearing, and basic literacy; Proficient in using a smartphone (patient or primary caregiver), willing to accept cloud-platform follow-up and participate throughout the study; Informed consent and voluntary participation.

Exclusion Criteria:

Presence of severe psychiatric disorders; Critically ill or debilitated patients with advanced-stage tumor who are unable to complete the study procedures.

Withdrawal Criteria:

Voluntary withdrawal or failure to complete the entire study process; Death during follow-up; Occurrence of accidents or clinical deterioration rendering continued participation infeasible; Request to withdraw for any reason.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; The control group received conventional telephone follow-up. Specifically, at 1 week and 3 weeks after discharge, ward follow-up nurses who had undergone standardized training conducted the follow-up using a pre-established checklist. The telephone calls covered pain intensity, location, medication usage, and adverse drug reactions.
Experimental: Intervention Group; Prior to discharge, a nurse instructed patients on using the cloud-based follow-up platform. Patients then reported outcomes weekly via the platform using the PROMIS-29 profile. The system automatically monitored this data against preset thresholds; any exceedance triggered an alert to the care team for immediate assessment. Based on the reported data, the system also pushed personalized education on pain management and medication. Follow-up calls provided further guidance, including on non-pharmacological techniques to complement analgesic therapy.	Other: Proactive monitoring and patient education; The intervention featured proactive monitoring of PRO data with threshold-based alerts, coupled with personalized patient education via the cloud and follow-up calls, to enhance timely care and self-management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain intensity	Use the Numerical Rating Scale (NRS) to assess pain intensity, with scores ranging from 0 to 10, where a higher number indicates more severe pain.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication adherence	Morisky questionnaire on medication adherence, with scores ranging from 0 to 8; a higher score indicates better medication adherence.	1 month

Collaborators and Investigators

• Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
• Investigators: Study Director: Huafang Zhang, MSN, 4th Affiliated Hospital, School of Medicine, Zhejiang University, China

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Actual): March 23, 2026

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Actual): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Cancer Pain; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Health Education; Patient Education as Topic
• Other Study ID Numbers: KY-2025-047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No