Construction and Feasibility Study of a Home-Based Intelligent Symptom Management Program for Lung Cancer Patients Receiving Combined Drug Therapy Based on Symptom Journey Profiling

Обзор

The goal of this clinical trial is to develop and evaluate a home-based intelligent symptom management program based on symptom journey profiles for patients with lung cancer receiving combination drug therapy. The program will be delivered through the "Zhihu Feifang" WeChat mini-program and is designed to help patients monitor symptoms, receive personalized symptom management recommendations, and obtain timely support during treatment intervals at home. The study will assess the feasibility, acceptability, and preliminary effectiveness of this intelligent symptom management program. The main research questions are as follows: (1) Is the intelligent symptom management program feasible and acceptable for patients with lung cancer receiving combination drug therapy? (2) Compared with usual care, can the program reduce symptom burden and improve symptom self-management ability? (3) Can the program improve quality of life and help patients identify and manage symptoms more promptly during treatment intervals? Researchers will compare the intelligent symptom management program with usual care to evaluate its preliminary effectiveness. Participants will be randomly assigned to either the intervention group or the usual care group. Participants in the intervention group will: (1) Receive usual care plus the "Zhihu Feifang" WeChat mini-program intervention; (2) Use the mini-program during four consecutive treatment intervals, lasting approximately 4 months; (3) Complete regular symptom assessments through the mini-program; (4) Receive personalized symptom management education, coping strategies, and risk alerts based on their symptom severity and symptom changes; (5) Receive nurse monitoring and follow-up support when needed; (6) Complete questionnaires at baseline and at follow-up time points during the study; (7) Some participants may also take part in an interview after the intervention to share their experience and suggestions. Participants in the usual care group will receive routine follow-up care, including health education, telephone follow-up, and medical visit guidance.

Вмешательства

• Поведенческое Home-Based Intelligent Symptom Management Program for Lung Cancer Patients During Intermittent Periods of Combined Drug Therapy
  The intervention group will receive routine care plus the home-based intelligent symptom management program. Participants will: ① complete regular symptom assessments through the mini-program; ② receive individualized symptom journey profiles based on symptom severity, symptom changes, and supportive care needs; ③ receive personalized health education, symptom management strategies, coping recommendations, and risk alerts; ④ receive nurse monitoring through the healthcare provider interface; ⑤ r
• Другое routine care
  ① Health education: prior to treatment, research nurses will provide patients with a "Home Health Education Manual for Patients with Lung Cancer," covering management of common adverse reactions, medication safety, dietary guidance, and exercise recommendations; ② Telephone follow-up: routine follow-up phone calls will be conducted according to departmental practice to assess symptom changes, psychological status, and medication adherence, while providing verbal guidance and health education; ③

Первичные конечные точки

• Change in symptom burden measured by the Symptom Assessment Scale for Intervals of Combination Therapy in Patients with Lung Cancer [Срок оценки: Baseline, at the end of Cycle 2 (each cycle is 21 days), and at the end of Cycle 4 (each cycle is 21 days).]

Вторичные конечные точки (8)

• Change in quality of life measured by the Functional Assessment of Cancer Therapy-Lung, version 4.0 (FACT-L, V4.0) [Срок оценки: Baseline, at the end of Cycle 2 (each cycle is 21 days), and at the end of Cycle 4 (each cycle is 21 days).]
• Change in self-management behavior measured by the Self-Management Behavior Scale for Lung Cancer Survivors [Срок оценки: Baseline, at the end of Cycle 2 (each cycle is 21 days), and at the end of Cycle 4 (each cycle is 21 days).]
• Mini-program usability measured by the Chinese version of the mHealth App Usability Questionnaire (MAUQ) [Срок оценки: At the end of Cycle 4 (each cycle is 21 days).]
• Recruitment rate [Срок оценки: At the end of Cycle 4 (each cycle is 21 days).]
• Retention rate [Срок оценки: At the end of Cycle 4 (each cycle is 21 days).]
• Attrition rate [Срок оценки: At the end of Cycle 4 (each cycle is 21 days).]
• Satisfaction with the intervention program and the mini-program [Срок оценки: At the end of Cycle 4 (each cycle is 21 days).]
• Adverse event [Срок оценки: From Cycle 1 to Cycle 4 (each cycle is 21 days）]

Критерии участия

Критерии включения

• Diagnosed with primary lung cancer confirmed by histology or cytology
• First-time recipient of combination drug therapy, with an expected treatment course of at least 4 cycles; the combination regimen is not restricted
• Aged 18 years or older
• Able to use a smartphone
• Eastern Cooperative Oncology Group performance status score of 2 or lower
• Aware of their own diagnosis and medication regimen
• Voluntarily agree to participate in this study

Критерии исключения

• History of mental illness or currently receiving mental health treatment
• Diagnosis of malignancy in another organ site
• Presence of cognitive impairment, indicated by 3 or more errors on the Short Portable Mental Status Questionnaire

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07632703 · FJMU-IRB-2025-442

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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