An observational study in Moderate to Severe Cancer Pain, sponsored by First Affiliated Hospital of Zhejiang University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by First Affiliated Hospital of Zhejiang University · Observational
This study is a multicenter cross-sectional observational study, aiming to include approximately 200 patients aged 18-75 years who are using hydrocodone sustained-release tablets or oxycodone sustained-release tablets for pain management of moderate to severe cancer pain. Baseline information, tumor history, and comorbidities of the subjects will be collected through electronic patient-reported outcomes (ePRO), and the pain condition will be evaluated using BPI, acute pain assessment tools, etc. Sleep-related indicators will be collected using Huawei smart wearable devices and PSQI, ISI scales. Psychological emotional states will be assessed using NCCN psychological distress thermometer, HAMA, HAMD, etc. Blood samples will also be collected for relevant tests. The study sets up a screening baseline assessment period, a 1-week assessment period, and 1-month and 3-month follow-up periods after enrollment. The changes in relevant indicators will be tracked throughout the process, aiming to quantify the association between pain and insomnia, anxiety and depression, and to verify the potential mediating role of sleep disorders between pain and emotional disorders, providing a basis for optimizing the comprehensive symptom management of cancer pain patients.
338 studies on the registry are indexed under Cancer Pain; 71 are open to participants now.
This study's planned enrollment of 200 is above the median of 140 across 68 observational studies indexed under Cancer Pain.
Browse Cancer Pain studies →First Affiliated Hospital of Zhejiang University is the lead sponsor of 255 studies on the registry; 139 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The subjects included patients with moderate to severe cancer pain who meet the inclusion and exclusion criteria for this study.
Exclusion Criteria:
No intervention
Numeric Rating Scale (NRS) Pain Score
Pain intensity was assessed using the 11-point Numeric Rating Scale (NRS). The scale ranges from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater severity of pain. The assessment was performed from day 1 to day 7 of the treatment phase.
Time frame: Treatment day 1 to day 7,1-month follow-up, 3-month follow-up
Hamilton Anxiety Rating Scale (HAM-A) Score
Anxiety levels were assessed using the Hamilton Anxiety Rating Scale (HAM-A). The HAM-A is a clinician-rated scale with a total score range of 0 to 56 points. Higher scores indicate greater severity of anxiety symptoms. The assessment was performed on day 7 of the treatment phase.
Time frame: Treatment day 7,1-month follow-up, 3-month follow-up
Hamilton Depression Rating Scale (HAM-D) Score
Depression levels were assessed using the Hamilton Depression Rating Scale (HAM-D). The HAM-D is a clinician-rated scale with a total score range of 0 to 52 points (17-item version). Higher scores indicate greater severity of depressive symptoms. The assessment was performed on day 7 of the treatment phase.
Time frame: Treatment day 7,1-month follow-up, 3-month follow-up
Pittsburgh Sleep Quality Index (PSQI) Score
Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI). The total score ranges from 0 to 21 points. Higher scores indicate poorer sleep quality. The assessment was performed from day 1 to day 7 of the treatment phase.
Time frame: Treatment day 7,1-month follow-up, 3-month follow-up
Plan to share: No
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First Affiliated Hospital of Zhejiang University