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Clinical Trials/NCT06663956
NCT06663956
Recruiting
Phase 2

A Randomized Controlled, Open Clinical Trial of a Web-based Platform for Multifactorial Intervention in Cancer Pain Management

West China Hospital1 site in 1 country100 target enrollmentNovember 10, 2024
ConditionsCancer Pain

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Cancer Pain
Sponsor
West China Hospital
Enrollment
100
Locations
1
Primary Endpoint
Patient's average pain level (derived from the Brief Pain Scale)
Status
Recruiting
Last Updated
9 months ago

Overview

Brief Summary

Malignant tumors are one of the major public health problems in China, and cancer pain is a common symptom in tumor patients, affecting the quality of life. In rural areas, cancer pain management is challenging due to insufficient medical resources and limitations in understanding cancer pain. Investigators plan to develop a convenient patient self-reporting applet to help participants report their symptoms to primary care physicians promptly and monitor pain levels and medication in real-time. This project aims to improve the efficiency of cancer pain management, integrate cancer pain into chronic disease management, improve the quality of healthcare services for rural participants, and promote the construction of a healthy China.

Registry
clinicaltrials.gov
Start Date
November 10, 2024
End Date
November 10, 2026
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Xingchen Peng

PhD, Professor

West China Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients with tumors that are confirmed by pathological findings.
  • Presence of tumor-related pain that is moderate or higher and requires intervention with morphine-based pain medication (++).
  • Have a life expectancy of more than 6 months.
  • Understand and sign a consent to participate in the study, or if the patient is unable to understand the study, his/her direct caregiver must have a good understanding of the study.

Exclusion Criteria

  • Presence of other chronic non-cancer pain/have an unresolved pain-related condition.
  • Moderately severe cognitive impairment/cognitive impairment.
  • Have schizophrenia or other psychiatric illness.
  • Neither the patient nor his/her direct caregiver can understand how to use the Cancer Pain Management applet.
  • Being pregnant.

Outcomes

Primary Outcomes

Patient's average pain level (derived from the Brief Pain Scale)

Time Frame: From patient enrollment to 3 months, during which time the applet was used once a week

The Brief Pain Inventory (BPI) is a validated tool for assessing pain intensity and impact on daily life. The BPI consists of two parts: the first part assesses the intensity of pain using a scale of 0 to 10, where 0 indicates no pain and 10 indicates the worst pain; the second part assesses the impact of pain on various aspects of the patient's life (e.g., mood, work, sleep, and social activities). The BPI is simple and easy to use, and can help healthcare professionals to quickly obtain quantitative information about pain and monitor the effectiveness of pain management.

Secondary Outcomes

  • Mood and physical state of the patient (derived from the EQ-5D scale)(From patient enrollment to 3 months, during which time the applet was used twice a week)
  • Burden situation of family members (derived from the Family Support Scale)(From patient enrollment to 3 months, during which time the applet was used twice a week)
  • Patient quality of life (derived from the QLQ-C30 core quality of life questionnaire)(From patient enrollment to 3 months, during which time the applet was used twice a week)

Study Sites (1)

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