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
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.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Feifei Huang Huang
- 電話番号：+86 13763869099
- メール：pt860315@163.com
研究連絡先のバックアップ
- 名前：Chenxing Zhang
- 電話番号：+86 18150815135
- メール：zcxing2024@163.com
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：介入群
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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.
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アクティブコンパレータ：対照群
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in symptom burden measured by the Symptom Assessment Scale for Intervals of Combination Therapy in Patients with Lung Cancer
時間枠：Baseline, at the end of Cycle 2 (each cycle is 21 days), and at the end of Cycle 4 (each cycle is 21 days).
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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.
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Baseline, at the end of Cycle 2 (each cycle is 21 days), and at the end of Cycle 4 (each cycle is 21 days).
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in quality of life measured by the Functional Assessment of Cancer Therapy-Lung, version 4.0 (FACT-L, V4.0)
時間枠：Baseline, at the end of Cycle 2 (each cycle is 21 days), and at the end of Cycle 4 (each cycle is 21 days).
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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.
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Baseline, at the end of Cycle 2 (each cycle is 21 days), and at the end of Cycle 4 (each cycle is 21 days).
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Change in self-management behavior measured by the Self-Management Behavior Scale for Lung Cancer Survivors
時間枠：Baseline, at the end of Cycle 2 (each cycle is 21 days), and at the end of Cycle 4 (each cycle is 21 days).
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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.
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Baseline, at the end of Cycle 2 (each cycle is 21 days), and at the end of Cycle 4 (each cycle is 21 days).
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Mini-program usability measured by the Chinese version of the mHealth App Usability Questionnaire (MAUQ)
時間枠：At the end of Cycle 4 (each cycle is 21 days).
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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.
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At the end of Cycle 4 (each cycle is 21 days).
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Recruitment rate
時間枠：At the end of Cycle 4 (each cycle is 21 days).
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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.
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At the end of Cycle 4 (each cycle is 21 days).
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Retention rate
時間枠：At the end of Cycle 4 (each cycle is 21 days).
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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.
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At the end of Cycle 4 (each cycle is 21 days).
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Attrition rate
時間枠：At the end of Cycle 4 (each cycle is 21 days).
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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.
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At the end of Cycle 4 (each cycle is 21 days).
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Satisfaction with the intervention program and the mini-program
時間枠：At the end of Cycle 4 (each cycle is 21 days).
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A qualitative interview was used to assess the participants' satisfaction with the intervention program and the mini-program.
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At the end of Cycle 4 (each cycle is 21 days).
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Adverse event
時間枠：From Cycle 1 to Cycle 4 (each cycle is 21 days）
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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.
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From Cycle 1 to Cycle 4 (each cycle is 21 days）
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Feifei Huang、Fujian Medical University
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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