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

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Status: Not yet enrolling

Conditions: Cancer Pain

Treatments: Other: Proactive monitoring and patient education

Study type: Interventional

Funder types: Other

Identifiers

NCT07308223

KY-2025-047

Details and patient eligibility

About

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.

Enrollment: 86 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 2 patient groups

Control Group

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Other: Proactive monitoring and patient education