Patient's Whole Process Follow-up Management(HOPE-1)

NCT05339568 | Recruiting

• 1 other identifier: WYKA001
• Study Type: observational
• Target: 1,268
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced Non-Small Cell Lung Cancer; Metastatic NSCLC

Outcome Measures

Primary Outcomes (1)

• Overall survival time

  OS was calculated from the date of randomization to death from any cause.

  UP to 96 months

Secondary Outcomes (5)

• Progression-free survival (PFS)

  Up to 96 months

• Adverse events rate

  Up to 96 months

• Patients' follow-up compliance

  Up to 96 months

• The quality of life

  Up to 96 months

• Follow-up satisfaction

  Up to 96 months

Study Arms (2)

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.

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.

Interventions

Patients' whole process follow-up and management platform OTHER

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.

Platform follow-up cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will enroll locally advanced/Metastatic NSCLC who are not suitable for radical treatment or refuse surgery.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jiandong ZHANG

  Shandong First Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiandong ZHANG

CONTACT

(+86531)89268118; zhangjd165@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Oncology Radiotherapy Department

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: April 21, 2022
• Study Start: May 22, 2022
• Primary Completion (Estimated): April 21, 2030
• Study Completion (Estimated): August 20, 2030
• Last Updated: September 8, 2022

Record last verified: 2022-09

Locations

CN (1)