An observational study in Locally Advanced Non-Small Cell Lung Cancer and Metastatic NSCLC, sponsored by Qianfoshan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-08.
Sponsored by Qianfoshan Hospital · Observational
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.
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 1,268 is above the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Qianfoshan Hospital is the lead sponsor of 140 studies on the registry; 73 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This study will enroll locally advanced/Metastatic NSCLC who are not suitable for radical treatment or refuse surgery.
Exclusion Criteria:
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.
Other: Patients' whole process follow-up and management platform
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.
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.
Overall survival time
OS was calculated from the date of randomization to death from any cause.
Time frame: UP to 96 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 96 months
Plan to share: 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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Qianfoshan Hospital