Clinical trial NCT06483295: Improving Patient-reported Outcomes After Lung Cancer Surgery With Mobile Internet Platform
Official title: Randomized Controlled Study on Improving Patient-reported Outcomes After Lung Cancer Surgery With Mobile Internet Platform
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: patient-reported outcomes
Internet
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study focuses on the significant impact of lung cancer in China, highlighted by its high incidence and mortality rates, influenced by factors like aging populations, smoking, and environmental issues. It emphasizes the importance of understanding the duration, severity, and factors affecting post-surgery symptoms like pain and coughing in patients. The research underlines the value of patient-reported outcomes (PROs) in enhancing postoperative care and survival rates through improved symptom monitoring and patient engagement. Utilizing internet technology, specifically a platform integrated with WeChat, the study aims to improve patient management and follow-ups post-discharge. The objective is to use mobile internet technology to build a high-quality prospective database on postoperative lung cancer patient outcomes, analyzing factors affecting postoperative discomfort and assessing the role of interactive platforms in improving patient care.

Detailed description: Lung cancer is the leading cause of cancer-related deaths worldwide. In China, it has become the malignancy with the highest incidence and mortality rates, exacerbated by aging populations, smoking, and environmental issues. Post-major lung surgery, patients often experience reduced quality of life due to symptoms like pain and coughing. However, the duration, severity, and factors influencing these symptoms during recovery are not fully understood. Notably, recent attention has been given to the direct collection of patient-reported outcomes (PROs) for subjective symptom monitoring and improving patient care. Incorporating PRO monitoring in cancer patient follow-ups can reduce postoperative discomfort, enhance treatment tolerance and adherence, detect early relapses, and improve survival rates. Internet technology significantly expands information exchange frequency and efficiency. Management platforms based on internet mobile applications can enhance patient management compliance, enable intelligent follow-ups, and strengthen doctor-patient interaction. The investigators' hospital intends to utilize its internet hospital platform, integrated with WeChat (a Tencent application in China), for assisting in-patient management and post-discharge surveillance through automated multimedia material and PROs. WeChat, similar to Facebook and WhatsApp, is a multifunctional messenger app with over a billion active monthly users in China, effectively using an application already familiar to patients rather than introducing new ones.

This study aims to leverage mobile internet technology to transform traditional database construction, enhance the efficiency and accuracy of prospective database information collection, and establish a high-quality prospective database of postoperative lung cancer patient-reported outcomes. This will facilitate the analysis of factors influencing postoperative discomfort in patients and explore the role of interactive mobile internet technology platforms in improving postoperative PROs, thereby elevating the diagnostic and treatment standards in this field.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed with Stage I-III lung cancer and surgically resected at our centre.
2. Owns and uses a smartphone and can use WeChat.
3. Volunteer to participate in this study and sign an informed consent form.

Exclusion Criteria:

1. Received any non-surgical anti-tumour therapy (radiotherapy, chemotherapy, targeted therapy or immunotherapy) for lung cancer during the follow-up period.
2. After enrolment, preoperative emergence of serious comorbidities (inability to tolerate surgery or anaesthesia) that are not suitable for, or cannot be implemented as planned, in the study's treatment regimen.
3. After admission, the patient's condition changes and the need to change from elective surgery to emergency surgery is confirmed by the doctor in charge.
4. At any stage after entering the study, the patient voluntarily requests to withdraw or discontinue treatment due to personal reasons.

Primary outcomes:
measure: complaints of discomfort
timeFrame: 4 months
Secondary outcomes:
measure: Life quality
timeFrame: 4 months
measure: Pulmonary function-the absolute value of FEV1
timeFrame: 4 months
measure: Pulmonary function-the percentage of FEV1 to expected values
timeFrame: 4 months
measure: Change of breath sounds
timeFrame: 4 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zuodong Song
state: Shanghai
Study officials:
affiliation: Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
name: Xinghua Cheng, MD
role: PRINCIPAL_INVESTIGATOR
References: