Development of a Cloud-Based PRO (Patient-Reported Outcome) Management Program for Home-Based Cancer Pain Care
NCT ID: NCT07308223
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
86 participants
INTERVENTIONAL
2026-01-31
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
No interventions assigned to this group
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
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.
18 Years
ALL
No
Sponsors
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The Fourth Affiliated Hospital of Zhejiang University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Huafang Zhang, MSN
Role: STUDY_DIRECTOR
4th Affiliated Hospital, School of Medicine, Zhejiang University, China
Locations
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4th Affiliated Hospital, School of Medicine
Yiwu, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Shaohua Zhang
Role: primary
Other Identifiers
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KY-2025-047
Identifier Type: -
Identifier Source: org_study_id