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
2026년 6월 2일 업데이트: 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.
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
중재적
등록 (추정된)
등록
60
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Feifei Huang Huang
- 전화번호: +86 13763869099
- 이메일: pt860315@163.com
연구 연락처 백업
- 이름: Chenxing Zhang
- 전화번호: +86 18150815135
- 이메일: zcxing2024@163.com
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 개입 그룹
|
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.
|
|
활성 비교기: 대조군
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in symptom burden measured by the Symptom Assessment Scale for Intervals of Combination Therapy in Patients with Lung Cancer
기간: 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).
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in quality of life measured by the Functional Assessment of Cancer Therapy-Lung, version 4.0 (FACT-L, V4.0)
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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）
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
협력자
수사관
수사관
- 연구 책임자: Feifei Huang, Fujian Medical University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
연구 시작
2026년 5월 25일
기본 완료 (추정된)
기본 완료
2027년 6월 30일
연구 완료 (추정된)
연구 완료
2027년 6월 30일
연구 등록 날짜
최초 제출
최초 제출
2026년 5월 21일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 6월 2일
처음 게시됨 (실제)
처음 게시됨
2026년 6월 8일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 6월 8일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 2일
마지막으로 확인됨
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- FJMU-IRB-2025-442
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
The datasets are not publicly available due privacy reasons but are available from the director under reasonable request.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .