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Recruiting NCT06663956

A Randomized Controlled Trial of a Web-based Platform for Cancer Pain Management

Phase III Interventional Cancer Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: a patient self-reporting applet.
Who it may be relevant to
Registry conditions: Cancer Pain. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Behavioral a patient self-reporting applet
    We propose to develop a patient self-reporting applet that is easy to use and simple to operate. The program is embedded with questionnaires related to cancer pain and quality of life assessment, so that patients can fill out the questionnaires to report their symptoms and changes in their conditions to primary care doctors in a timely manner. At the same time, the background of the program will monitor the patient's indicators in real time. When the patient's pain reaches moderate-to-severe lev

Primary outcome measures

  • 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]
Secondary outcome measures (3)
  • Mood and physical state of the patient (derived from the EQ-5D scale) [Time frame: 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) [Time frame: 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) [Time frame: From patient enrollment to 3 months, during which time the applet was used twice a week]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

China · 1 center
  • West China Hospital, Sichuan Universit — Chengdu

Identifiers

NCT: NCT06663956 · 2024-1948

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗