Locally Advanced Non-Small Cell Lung CancerHOPE-1NCT05339568
Patient's Whole Process Follow-up Management(HOPE-1)
An observational study of Locally Advanced Non-Small Cell Lung Cancer and Metastatic NSCLC, run by Qianfoshan Hospital at 1 site in China.
Trial summary
Our project is going to explore whether management and follow-up of locally advanced/metastatic patients using the patient process management platform can prolong patient survival and improve patient quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Non-Small Cell Lung Cancer, Metastatic NSCLC
- What is being tested?
- Patients' whole process follow-up and management platform
- How many people
- 1,268 participants
- Where
- 1 siteChina
- Study dates
- 22 May 2022to 20 Aug 2030
- Phase
- Observational
- 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
Study population: This study will enroll locally advanced/Metastatic NSCLC who are not suitable for radical treatment or refuse surgery.
Who may be able to join
- Fully understand the research and voluntarily sign the informed consent form (ICF)
- Male or female subjects who are over 18 years old (inclusive) at the time of signing the informed consent form.
- The subject is diagnosed pathologically or cytologically with non-small cell lung cancer(NSCLC).
- According to the 8th edition of the American Joint Committee on Cancer [AJCC], it is classified as stage IIB, stage III, stage IV NSCLC.
- Not suitable for radical treatment or refuse surgery.
- The life expectancy is not less than 3 months.
- Be able to use a smartphone.
Who cannot join
- Patients with mental illness.
- Presence of any other malignant tumor.
- Patients who are expected to undergo radical surgery.
- Currently participating in clinical trials.
- Subjects who judged by the investigator to be unsuitable to participate in the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong
Jiandong ZHANG, +8653189268118, zhangjd165@sina.com
About this study
Official title: A Multicenter, Randomized, Open, Parallel Grouping, Investigator-initiated Study Evaluating the Long-term Benefit of Patients With Locally Advanced/Metastatic Non-small Cell Lung Cancer Followed up Using a Patient-wide Management Platform
Our project is going to explore whether management and follow-up of locally advanced/metastatic patients using the patient process management platform can prolong patient survival and improve patient quality of life.
Read the detailed description
Now, the treatment of NSCLC is diversiform, such as radiation and chemotherapy, targeted therapy, immune therapy, the treatment goal is to reduce symptoms, improve quality of life, prolong life. But as a result of the disease itself has the high risk of metastasis and recurrence. The treatment is often accompanied by a series of complications, if the patients don't get medical assistance in time, it will lead high risk to physical and mental health of patients. In China, the intermittent period of domestic treatment is mainly family recuperation, but due to the lack of medical knowledge or self-management and self-restraint ability of patients, they may forget to take medicine, stop medication without permission due to side effects and other behaviors that do not follow the doctor's advice, the poorly patients' compliance will lead to a significant reduction in the treatment effect. NSCLC are often accompanied by anxiety, fear, insomnia and other symptoms, causing a huge psychological burden on patients and their families, affecting the quality of life. Whole process follow-up in tumor therapy plays an important role , it is the crucial link between medical, nursing, and patients. Patients' whole process follow-up and management is an important part of cancer disease management.
It is helpful to relieve the patients and their families of the bad psychology, reduce the symptoms of patients, improve the patient's compliance behavior, relieve the psychological anxiety of patients, make it actively cooperate with the treatment, reduce complications, improve the quality of life of patients, so as to prolong the life cycle.
Our project is going to explore whether management and follow-up of locally advanced/metastatic patients using the patient process management platform can prolong patient survival and improve patient quality of life.
- Being tested
- Patients' whole process follow-up and management platform
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients' whole process follow-up and management platformOther
Patients' whole process follow-up and management platform is a software for the patients and investigators. This platform will use to collect patients' information when they are out of patients and will provide the patients' education materials.
| Study group | Role | What they receive |
|---|---|---|
| Platform follow-up cohort | This cohort will be managed and follow-up by patients' whole process follow-up platform. The patients can report the symptoms, get the reminder of the hospital visit, get the reminder of medicine taking, get the information of patients education. Receives: Other: Patients' whole process follow-up and management platform | |
| Routine follow-up cohort | This cohort will be managed and follow-up by the investigators or nurses. This cohort will take the routine follow-up and management way by the hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival time
OS was calculated from the date of randomization to death from any cause.
Measured: UP to 96 months
Secondary outcomes (5)
Progression-free survival (PFS)
PFS was calculated from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 96 months.
Measured: Up to 96 months
Adverse events rate
Adverse events were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0.
Measured: Up to 96 months
Patients' follow-up compliance
Patients' follow-up compliance were assessed by the N of hospital visits according to the doctors' advice every year.
Measured: Up to 96 months
The quality of life
The quality of life were assessed by SF-36，The SF-36 questionnaire consists of 8 section, including physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health, also including reported health transition. The scoring steps: 1 encode the scale 2 credit the scale 3 score conversion(conversion formula=(actual score-the possible lowest score of this section)/the difference between the possible highest score and the possible lowest score of this section).The higher the score conversion, the better the health.
Measured: Up to 96 months
Follow-up satisfaction
Follow-up satisfaction were assessed by the questionnaire. The questionnaire is including 12 questions, where 28 is the worst imaginable satisfaction state and 130 is the best imaginable satisfaction state.
Measured: Up to 96 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start22 May 2022
- Primary completion21 Apr 2030 (estimated)
- Study completion20 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Non-Small Cell Lung CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,268 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiandong Zhang, Qianfoshan Hospital
- Investigators
- Jiandong ZHANG, Principal investigator, Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339568
- Sponsor's protocol ID
- WYKA001
- Acronym
- HOPE-1
- Status last verified
- Sep 2022
- First submitted
- 15 Apr 2022
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not decided to share IPD or not, we will discuss by all the investigators, after discussion, we will update the status.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open, Parallel Grouping, Investigator-initiated Study Evaluating the Long-term Benefit of Patients With Locally Advanced/Metastatic Non-small Cell Lung Cancer Followed up Using a Patient-wide Management Platform
- ClinicalTrials.gov ID
- NCT05339568
- Acronym / sponsor ID
- HOPE-1 / WYKA001
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,268 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 22 May 2022 (actual)
- Primary completion
- 21 Apr 2030 (estimated)
- Study completion
- 20 Aug 2030 (estimated)
- First posted
- 21 Apr 2022 (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.
Our project is going to explore whether management and follow-up of locally advanced/metastatic patients using the patient process management platform can prolong patient survival and improve patient quality of life.
Detailed description
Now, the treatment of NSCLC is diversiform, such as radiation and chemotherapy, targeted therapy, immune therapy, the treatment goal is to reduce symptoms, improve quality of life, prolong life. But as a result of the disease itself has the high risk of metastasis and recurrence. The treatment is often accompanied by a series of complications, if the patients don't get medical assistance in time, it will lead high risk to physical and mental health of patients. In China, the intermittent period of domestic treatment is mainly family recuperation, but due to the lack of medical knowledge or self-management and self-restraint ability of patients, they may forget to take medicine, stop medication without permission due to side effects and other behaviors that do not follow the doctor's advice, the poorly patients' compliance will lead to a significant reduction in the treatment effect. NSCLC are often accompanied by anxiety, fear, insomnia and other symptoms, causing a huge psychological burden on patients and their families, affecting the quality of life. Whole process follow-up in tumor therapy plays an important role , it is the crucial link between medical, nursing, and patients. Patients' whole process follow-up and management is an important part of cancer disease management.
It is helpful to relieve the patients and their families of the bad psychology, reduce the symptoms of patients, improve the patient's compliance behavior, relieve the psychological anxiety of patients, make it actively cooperate with the treatment, reduce complications, improve the quality of life of patients, so as to prolong the life cycle.
Our project is going to explore whether management and follow-up of locally advanced/metastatic patients using the patient process management platform can prolong patient survival and improve patient quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platform follow-up cohort | – | Other: Patients' whole process follow-up and management platformThis cohort will be managed and follow-up by patients' whole process follow-up platform. The patients can report the symptoms, get the reminder of the hospital visit, get the reminder of medicine taking, get the information of patients education. |
| Routine follow-up cohort | – | –This cohort will be managed and follow-up by the investigators or nurses. This cohort will take the routine follow-up and management way by the hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll locally advanced/Metastatic NSCLC who are not suitable for radical treatment or refuse surgery.
Key inclusion criteria (7 listed)
- Fully understand the research and voluntarily sign the informed consent form (ICF)
- Male or female subjects who are over 18 years old (inclusive) at the time of signing the informed consent form.
- The subject is diagnosed pathologically or cytologically with non-small cell lung cancer(NSCLC).
- According to the 8th edition of the American Joint Committee on Cancer [AJCC], it is classified as stage IIB, stage III, stage IV NSCLC.
- Not suitable for radical treatment or refuse surgery.
Key exclusion criteria (5 listed)
- Patients with mental illness.
- Presence of any other malignant tumor.
- Patients who are expected to undergo radical surgery.
- Currently participating in clinical trials.
- Subjects who judged by the investigator to be unsuitable to participate in the trial.
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 |
|---|---|---|
| Patients' whole process follow-up and management platformPatients' whole process follow-up and management platform is a software for the patients and investigators. This platform will use to collect patients' information when they are out of patients and will provide the patients' education materials. | Other | Platform follow-up cohort |
Primary outcome
Overall survival time
Time frame: UP to 96 months
OS was calculated from the date of randomization to death from any cause.
5 secondary outcomes
Progression-free survival (PFS)
Time frame: Up to 96 months
Adverse events rate
Time frame: Up to 96 months
Patients' follow-up compliance
Time frame: Up to 96 months
The quality of life
Time frame: Up to 96 months
Follow-up satisfaction
Time frame: Up to 96 months
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 Sep 2022.
- Individual participant dataSharing planned: Undecided. Not decided to share IPD or not, we will discuss by all the investigators, after discussion, we will update the status.
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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.
Jiandong ZHANG principal investigator
Shandong First Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced Non-Small Cell Lung Cancer and Metastatic NSCLC, run by Qianfoshan Hospital at 1 site in China.
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 5 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: looking for participants now, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Jiandong ZHANG ((+86531)89268118, zhangjd165@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival time (time frame: UP to 96 months). 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 Sep 2022.