Moderate to Severe Cancer Pain
Conditions
Keywords
cancer pain
Brief summary
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.
Interventions
OTHERNo intervention
No intervention
Sponsors
First Affiliated Hospital of Zhejiang University
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18-75 years. 2. Histopathologically or cytologically confirmed diagnosis of malignancy, with moderate to severe cancer-related pain (NRS ≥ 4 points), meeting the WHO three-step analgesic ladder principle, having received opioid analgesic therapy for at least one week with a stable dose and well-controlled pain. 3. ECOG performance status score ≤ 3. 4. Possess basic cognitive function and ability to complete questionnaire-based assessments and wristband-based sleep monitoring. 5. Voluntarily sign the informed consent form and agree to comply with the study follow-up procedures.
Exclusion criteria
1. Severe cognitive impairment, history of psychiatric disorder, or language/communication barriers that precludes completion of the assessments. 2. History of opioid abuse or dependence; history of alcohol or non-opioid substance abuse. 3. Severe hepatic or renal insufficiency (Child-Pugh Class C or eGFR \< 30 mL/min). 4. Life expectancy \< 3 months. 5. Women of childbearing age without effective contraception, or who are pregnant or breastfeeding. 6. Presence of other serious diseases or special conditions that, in the investigator's judgment, may interfere with the study outcomes. 7. Presence of contraindications to the study drug, such as paralytic ileus, chronic obstructive respiratory disease, or cor pulmonale.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale (NRS) Pain Score | Treatment day 1 to day 7,1-month follow-up, 3-month follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Anxiety Rating Scale (HAM-A) Score | Treatment day 7,1-month follow-up, 3-month follow-up | 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. |
| Hamilton Depression Rating Scale (HAM-D) Score | Treatment day 7,1-month follow-up, 3-month follow-up | 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. |
| Pittsburgh Sleep Quality Index (PSQI) Score | Treatment day 7,1-month follow-up, 3-month follow-up | 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. |
Countries
China
Contacts
CONTACTZhiying Feng, MD
PRINCIPAL_INVESTIGATORZhiying
The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang
Outcome results
None listed