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NCT07632703
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
Conditions: Lung Neoplasms, Symptom Management, mHealth Intervention
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Feifei Huang
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT07632703). StuddyBuddy aggregates publicly available trial information.