Patient's Whole Process Follow-up Management(HOPE-1)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Patients' whole process follow-up and management platform.
- Who it may be relevant to
- Registry conditions: Locally Advanced Non-Small Cell Lung Cancer, Metastatic NSCLC. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Other Patients' whole process follow-up and management platform
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.
Primary outcome measures
- Overall survival time [Time frame: UP to 96 months]
Secondary outcome measures (5)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The First Affiliated Hospital of Shandong First Medical University — Jinan
Identifiers
NCT: NCT05339568 · WYKA001