Clinical trial NCT05339568: Patient's Whole Process Follow-up Management(HOPE-1)
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Locally Advanced Non-Small Cell Lung Cancer
Metastatic NSCLC
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 1268
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will enroll locally advanced/Metastatic NSCLC who are not suitable for radical treatment or refuse surgery.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Fully understand the research and voluntarily sign the informed consent form (ICF)
2. Male or female subjects who are over 18 years old (inclusive) at the time of signing the informed consent form.
3. The subject is diagnosed pathologically or cytologically with non-small cell lung cancer(NSCLC).
4. According to the 8th edition of the American Joint Committee on Cancer \[AJCC\], it is classified as stage IIB, stage III, stage IV NSCLC.
5. Not suitable for radical treatment or refuse surgery.
6. The life expectancy is not less than 3 months.
7. Be able to use a smartphone.

Exclusion Criteria:

1. Patients with mental illness.
2. Presence of any other malignant tumor.
3. Patients who are expected to undergo radical surgery.
4. Currently participating in clinical trials.
5. Subjects who judged by the investigator to be unsuitable to participate in the trial.

Primary outcomes:
measure: Overall survival time
timeFrame: UP to 96 months
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Up to 96 months
measure: Adverse events rate
timeFrame: Up to 96 months
measure: Patients' follow-up compliance
timeFrame: Up to 96 months
measure: The quality of life
timeFrame: Up to 96 months
measure: Follow-up satisfaction
timeFrame: Up to 96 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University
state: Shandong
Study officials:
affiliation: Shandong First Medical University
name: Jiandong ZHANG
role: PRINCIPAL_INVESTIGATOR
References: