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

NCT07632703 | Not Yet Recruiting

• 1 other identifier: FJMU-IRB-2025-442
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lung Neoplasms; Symptom Management; mHealth Intervention

Outcome Measures

Primary Outcomes (1)

• Change in symptom burden measured by the Symptom Assessment Scale for Intervals of Combination Therapy in Patients with Lung Cancer

  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.

  Baseline, at the end of Cycle 2 (each cycle is 21 days), and at the end of Cycle 4 (each cycle is 21 days).

Secondary Outcomes (8)

• 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).

• 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).

• 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).

• Recruitment rate

  At the end of Cycle 4 (each cycle is 21 days).

• Retention rate

  At the end of Cycle 4 (each cycle is 21 days).

Study Arms (2)

Control group

ACTIVE COMPARATOR

Other: routine care

Intervention group

EXPERIMENTAL

Behavioral: Home-Based Intelligent Symptom Management Program for Lung Cancer Patients During Intermittent Periods of Combined Drug Therapy

Interventions

Home-Based Intelligent Symptom Management Program for Lung Cancer Patients During Intermittent Periods of Combined Drug Therapy BEHAVIORAL

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.

Intervention group

routine care OTHER

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Feifei Huang: lead
• The Affiliated Hospital of Putian University: collaborator

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Feifei Huang

  Fujian Medical University

  STUDY DIRECTOR

Central Study Contacts

Feifei Huang Huang

CONTACT

+86 13763869099; pt860315@163.com

Chenxing Zhang

CONTACT

+86 18150815135; zcxing2024@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 8, 2026
• Study Start: May 25, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share