Patient's Whole Process Follow-up Management(HOPE-1)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorQianfoshan Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients with mental illness.
Presence of any other malignant tumor.
Patients who are expected to undergo radical surgery.
Currently participating in clinical trials.
Trial population
This study will enroll locally advanced/Metastatic NSCLC who are not suitable for radical treatment or refuse surgery.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Patients' whole process follow-up and management platform
Other interventionPatients' 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.
Treatment groups
1,268 Participants
are divided into 2 treatment groupsGroup A: Platform follow-up cohort1 intervention
Group B: Routine follow-up cohort0 interventions
Trial outcomes
Primary outcomes
1
Overall survival time
OS was calculated from the date of randomization to death from any cause.
Time frame
UP to 96 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov