Cancer PainNCT07308223
Development of a Cloud-Based PRO (Patient-Reported Outcome) Management Program for Home-Based Cancer Pain Care
A study testing Proactive monitoring and patient education in people with Cancer Pain, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Pain
- What is being tested?
- Proactive monitoring and patient education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Jan 2026to 23 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cancer Pain
- Being tested
- Proactive monitoring and patient education
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proactive monitoring and patient educationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Proactive monitoring and patient education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (1)
Medication adherence
Morisky questionnaire on medication adherence, with scores ranging from 0 to 8; a higher score indicates better medication adherence.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionMar 2026 (estimated)
- Study completion23 Mar 2026
Why it stopped: The study was withdrawn due to protocol revision and scientific re-evaluation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huafang Zhang, MSN, Study director, 4th Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308223
- Sponsor's protocol ID
- KY-2025-047
- Status last verified
- Mar 2026
- First submitted
- 15 Dec 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 4th Affiliated Hospital, School of Medicine, Zhejiang University, China
- ClinicalTrials.gov ID
- NCT07308223
- Acronym / sponsor ID
- KY-2025-047
- Conditions
- Cancer Pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn due to protocol revision and scientific re-evaluation
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- 23 Mar 2026 (actual)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Proactive monitoring and patient educationPrior 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- Presence of severe psychiatric disorders; Critically ill or debilitated patients with advanced-stage tumor who are unable to complete the study procedures.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proactive monitoring and patient educationThe 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. | Other | Intervention Group |
Primary outcome
pain intensity
Time frame: 1 month
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 secondary outcome
Medication adherence
Time frame: 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huafang Zhang, MSN study director
4th Affiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proactive monitoring and patient education in people with Cancer Pain, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain intensity (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.