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

Sichuan University

Status and phase: Enrolling; Phase 2

Conditions: Cancer Pain

Treatments: Behavioral: a patient self-reporting applet

Study type: Interventional

Funder types: Other

Identifiers

NCT06663956

2024-1948

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Control group

No Intervention group

Description:

The conventional treatment paradigm is in the current paradigm of standard antitumor cancer pain treatment and follow-up with no warning and no patient feedback.

Experimental group

Experimental group

Description:

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 level, or when the patient experiences side effects of drugs, or when the patient's adherence to medication is poor, the primary care doctor can immediately receive relevant alerts through the app, so as to intervene in the patient's cancer pain treatment. When the patient has an "alarm value", primary care doctors can provide feedback to doctors in higher-level hospitals and implement comprehensive and standardized treatment for cancer pain patients.

Treatment:

Behavioral: a patient self-reporting applet