Lung Neoplasms, mHealth Intervention, Symptom Management
Conditions
Brief 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.
Interventions
BEHAVIORALHome-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 receive timely follow-up support when symptoms worsen or when additional guidance is needed; and ⑥ some participants may take part in interviews after the intervention to share their experience, satisfaction, and suggestions.
OTHERroutine 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 Medical visit guidance: if patients report worsening symptoms or new discomfort, nurses will provide guidance or recommend timely outpatient review or hospitalization assessment in the oncology department.
Sponsors
Feifei Huang
The Affiliated Hospital of Putian University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in symptom burden measured by the Symptom Assessment Scale for Intervals of Combination Therapy in Patients with Lung Cancer | Baseline, at the end of Cycle 2 (each cycle is 21 days), and at the end of Cycle 4 (each cycle is 21 days). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in quality of life measured by the Functional Assessment of Cancer Therapy-Lung, version 4.0 (FACT-L, V4.0) | Baseline, at the end of Cycle 2 (each cycle is 21 days), and at the end of Cycle 4 (each cycle is 21 days). | Quality of life will be assessed using the Functional Assessment of Cancer Therapy-Lung, version 4.0. The scale consists of 36 items across five domains: physical well-being, social/family well-being, emotional well-being, functional well-being, and lung cancer-specific concerns. Items are rated on a 5-point Likert scale ranging from 0 ("not at all") to 4 ("very much"). Negatively worded items are reverse scored as appropriate. Total scores range from 0 to 144, with higher scores indicating better quality of life. |
| Change in self-management behavior measured by the Self-Management Behavior Scale for Lung Cancer Survivors | Baseline, at the end of Cycle 2 (each cycle is 21 days), and at the end of Cycle 4 (each cycle is 21 days). | Self-management behavior will be assessed using the Self-Management Behavior Scale for Lung Cancer Survivors. The scale includes 47 items across six domains: daily life management, symptom management, follow-up management, information and resource management, emotional management, and hope management. Items are rated on a 5-point Likert scale ranging from 1 ("completely unable to do") to 5 ("always able to do"). Total scores range from 47 to 235, with higher scores indicating better self-management behavior among lung cancer survivors. |
| Mini-program usability measured by the Chinese version of the mHealth App Usability Questionnaire (MAUQ) | At the end of Cycle 4 (each cycle is 21 days). | Mini-program usability will be assessed using the Chinese version of the mHealth App Usability Questionnaire (MAUQ). The questionnaire consists of 21 items across three domains: ease of use and satisfaction (8 items), system information arrangement (6 items), and usefulness (7 items). Items are rated on a 7-point Likert scale ranging from 1 ("strongly agree") to 7 ("strongly disagree"). Mean scores closer to 1 indicate higher usability of the mHealth mini-program. |
| Recruitment rate | At the end of Cycle 4 (each cycle is 21 days). | The number of patients who agree to participate in the study divided by the number of patients with lung cancer who meet the eligibility criteria. |
| Retention rate | At the end of Cycle 4 (each cycle is 21 days). | The number of patients with lung cancer who complete the study procedures divided by the number of patients enrolled in the study. Reasons for withdrawal will also be recorded. |
| Attrition rate | At the end of Cycle 4 (each cycle is 21 days). | The number of patients with lung cancer who withdraw from the intervention or fail to complete all assessments during the study divided by the number of patients enrolled in the study. Reasons for attrition will also be recorded. |
| Satisfaction with the intervention program and the mini-program | At the end of Cycle 4 (each cycle is 21 days). | A qualitative interview was used to assess the participants' satisfaction with the intervention program and the mini-program. |
| Adverse event | From Cycle 1 to Cycle 4 (each cycle is 21 days） | Adverse events will be recorded using a self-developed adverse event registration form, including negative emotional reactions during the intervention process (e.g., fear, silence, emotional indifference), causes of adverse events, management measures, and follow-up outcomes. |
Contacts
CONTACTFeifei Huang Huang
CONTACTChenxing Zhang
STUDY_DIRECTORFeifei Huang
Fujian Medical University
Outcome results
None listed