Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| mHealth Intervention | — | UNRESOLVED | — |
| Symptom Management | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Home-Based Intelligent Symptom Management Program for Lung Cancer Patients During Intermittent Periods of Combined Drug Therapy | Behavioral | — | UNRESOLVED |
| routine care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control group
- interventionNames
- Other: routine care
- type
- EXPERIMENTAL
- label
- Intervention group
- interventionNames
- Behavioral: Home-Based Intelligent Symptom Management Program for Lung Cancer Patients During Intermittent Periods of Combined Drug Therapy
Primary outcomes (1)
- measure
- Change in symptom burden measured by the Symptom Assessment Scale for Intervals of Combination Therapy in Patients with Lung Cancer
- timeFrame
- Baseline, at the end of Cycle 2 (each cycle is 21 days), and at the end of Cycle 4 (each cycle is 21 days).
- description
- Symptom burden will be assessed using the Symptom Assessment Scale for Intervals of Combination Therapy in Patients with Lung Cancer. The scale assesses symptom severity over the previous 24 hours and includes seven symptom systems: respiratory and circulatory symptoms, gastrointestinal symptoms, neuromuscular symptoms, dermatological symptoms, sleep-related symptoms, general somatic symptoms, and psychological symptoms. The scale consists of 60 symptom items, each rated on an 11-point numeric rating scale ranging from 0 (no symptom) to 10 (most severe symptom). Total scores range from 0 to 600, with higher scores indicating greater symptom burden and worse symptom severity.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available