Lung NeoplasmsNCT07632703
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
A study testing Home-Based Intelligent Symptom Management Program for Lung Cancer Patients During Intermittent Periods of Combined Drug Therapy and routine care in people with Lung Neoplasms and Symptom Management, run by Feifei Huang.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms, Symptom Management, mHealth Intervention
- What is being tested?
- Home-Based Intelligent Symptom Management Program for Lung Cancer Patients During Intermittent Periods of Combined Drug Therapy and routine care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 25 May 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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
- Being tested
- Home-Based Intelligent Symptom Management Program for Lung Cancer Patients During Intermittent Periods of Combined Drug Therapy, routine care
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-Based Intelligent Symptom Management Program for Lung Cancer Patients During Intermittent Periods of Combined Drug TherapyBehavioural
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.
routine careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Not described Receives: Other: routine care |
| Intervention group | Experimental | Not described Receives: Behavioral: Home-Based Intelligent Symptom Management Program for Lung Cancer Patients During Intermittent Periods of Combined Drug Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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
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.
Measured: 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)
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.
Measured: At the end of Cycle 4 (each cycle is 21 days).
Recruitment rate
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.
Measured: At the end of Cycle 4 (each cycle is 21 days).
Retention rate
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.
Measured: At the end of Cycle 4 (each cycle is 21 days).
Attrition rate
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.
Measured: At the end of Cycle 4 (each cycle is 21 days).
Satisfaction with the intervention program and the mini-program
A qualitative interview was used to assess the participants' satisfaction with the intervention program and the mini-program.
Measured: At the end of Cycle 4 (each cycle is 21 days).
Adverse event
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.
Measured: From Cycle 1 to Cycle 4 (each cycle is 21 days）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start25 May 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Feifei Huang
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Hospital of Putian University
- Responsible party
- Sponsor-investigator, Feifei Huang, Fujian Medical University
- Investigators
- Feifei Huang, Study director, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07632703
- Sponsor's protocol ID
- FJMU-IRB-2025-442
- Status last verified
- Jun 2026
- First submitted
- 21 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets are not publicly available due privacy reasons but are available from the director under reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07632703
- Acronym / sponsor ID
- FJMU-IRB-2025-442
- Conditions
- Lung Neoplasms, Symptom Management, mHealth Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Feifei HuangUniversity, hospital or other
- Collaborators
- The Affiliated Hospital of Putian University
- Study start
- 25 May 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-Based Intelligent Symptom Management Program for Lung Cancer Patients During Intermittent Periods of Combined Drug TherapyThe 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. | Behavioural | Intervention group |
| routine care① 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. | Other | Control group |
Primary outcome
Change in symptom burden measured by the Symptom Assessment Scale for Intervals of Combination Therapy in Patients with Lung Cancer
Time frame: 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.
8 secondary outcomes
Change in quality of life measured by the Functional Assessment of Cancer Therapy-Lung, version 4.0 (FACT-L, V4.0)
Time frame: 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
Time frame: 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)
Time frame: At the end of Cycle 4 (each cycle is 21 days).
Recruitment rate
Time frame: At the end of Cycle 4 (each cycle is 21 days).
Retention rate
Time frame: At the end of Cycle 4 (each cycle is 21 days).
Attrition rate
Time frame: At the end of Cycle 4 (each cycle is 21 days).
Satisfaction with the intervention program and the mini-program
Time frame: At the end of Cycle 4 (each cycle is 21 days).
Adverse event
Time frame: From Cycle 1 to Cycle 4 (each cycle is 21 days）
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No. The datasets are not publicly available due privacy reasons but are available from the director under reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Feifei Huang study director
Fujian Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Home-Based Intelligent Symptom Management Program for Lung Cancer Patients During Intermittent Periods of Combined Drug Therapy and routine care in people with Lung Neoplasms and Symptom Management, run by Feifei Huang.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feifei Huang Huang (+86 13763869099, pt860315@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in symptom burden measured by the Symptom Assessment Scale for Intervals of Combination Therapy in Patients with Lung Cancer (time frame: Baseline, at the end of Cycle 2 (each cycle is 21 days), and at the end of Cycle 4 (each cycle is 21 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.