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

NCT07308223 | Not Yet Recruiting

• 1 other identifier: KY-2025-047
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer Pain

Outcome Measures

Primary Outcomes (1)

• pain intensity

  Use the Numerical Rating Scale (NRS) to assess pain intensity

  1 month

Secondary Outcomes (1)

• Medication adherence

  1 month

Study Arms (2)

Control Group

NO INTERVENTION

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.

Intervention Group

EXPERIMENTAL

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

Interventions

Proactive monitoring and patient education OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older;
• Pathologically confirmed diagnosis of cancer with concomitant pain requiring analgesic medication; ③ Alert and oriented, free of psychiatric disorders or cognitive impairment; ④ Adequate comprehension, essentially normal vision and hearing, and basic literacy; ⑤ Proficient in using a smartphone (patient or primary caregiver), willing to accept cloud-platform follow-up and participate throughout the study;
• ⑥ Informed consent and voluntary participation.

You may not qualify if:

• ① Presence of severe psychiatric disorders;
• ② 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; ③ Occurrence of accidents or clinical deterioration rendering continued participation infeasible; ④ Request to withdraw for any reason.

Sponsors & Collaborators

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

4th Affiliated Hospital, School of Medicine

Yiwu, Zhejiang, 32200-, China

Location

MeSH Terms

Conditions

Cancer Pain

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Huafang Zhang, MSN

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

  STUDY DIRECTOR

Central Study Contacts

Chenxi Ye, MSN

CONTACT

8657989935056; yechenxi@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 29, 2025
• Study Start: January 1, 2026
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)