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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• Patient's average pain level (derived from the Brief Pain Scale) [Срок оценки: From patient enrollment to 3 months, during which time the applet was used once a week]

Вторичные конечные точки (3)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Китай · 1 центр

• West China Hospital, Sichuan Universit — Чэнду

Идентификаторы

NCT: NCT06663956 · 2024-1948

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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