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

NCT06663956 | Recruiting Phase 3

• 1 other identifier: 2024-1948
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Pain

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Secondary Outcomes (3)

• 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

Other Outcomes (1)

• Radiotherapy interruption rate

  The time period is the period from the start of radiotherapy to the completion of radiotherapy.The evaluation period is approximately 6 weeks and 6.5 weeks.

Study Arms (2)

Control group

NO INTERVENTION

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

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.

Behavioral: a patient self-reporting applet

Interventions

a patient self-reporting applet BEHAVIORAL

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.

Experimental group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan Universit

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Cancer Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xingchen Peng

CONTACT

18980606753; pxx2014@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Professor

Study Record Dates

• First Submitted: October 26, 2024
• First Posted: October 29, 2024
• Study Start: November 10, 2024
• Primary Completion (Estimated): November 10, 2026
• Study Completion (Estimated): November 10, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)