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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

2. juni 2026 opdateret af: Feifei Huang

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Feifei Huang Huang
  • Telefonnummer: +86 13763869099
  • E-mail: pt860315@163.com

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Interventionsgruppe
Adfærdsmæssigt: 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 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.
Aktiv komparator: Kontrolgruppe
Andet: 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 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.

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in quality of life measured by the Functional Assessment of Cancer Therapy-Lung, version 4.0 (FACT-L, V4.0)
Tidsramme: 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.
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
Tidsramme: 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.
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)
Tidsramme: 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.
At the end of Cycle 4 (each cycle is 21 days).
Recruitment rate
Tidsramme: 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.
At the end of Cycle 4 (each cycle is 21 days).
Retention rate
Tidsramme: 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.
At the end of Cycle 4 (each cycle is 21 days).
Attrition rate
Tidsramme: 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.
At the end of Cycle 4 (each cycle is 21 days).
Satisfaction with the intervention program and the mini-program
Tidsramme: 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.
At the end of Cycle 4 (each cycle is 21 days).
Adverse event
Tidsramme: 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.
From Cycle 1 to Cycle 4 (each cycle is 21 days）

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Feifei Huang

Samarbejdspartnere

The Affiliated Hospital of Putian University

Efterforskere

  • Studieleder: Feifei Huang, Fujian Medical University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

25. maj 2026

Primær færdiggørelse (Anslået)

30. juni 2027

Studieafslutning (Anslået)

30. juni 2027

Datoer for studieregistrering

Først indsendt

21. maj 2026

Først indsendt, der opfyldte QC-kriterier

2. juni 2026

Først opslået (Faktiske)

8. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FJMU-IRB-2025-442

Plan for individuelle deltagerdata (IPD)

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IPD-planbeskrivelse

The datasets are not publicly available due privacy reasons but are available from the director under reasonable request.

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