Clinical trial NCT06725225: Machine Learning for Predicting and Managing Quality of Life in Lung Cancer Immunotherapy Patients
Official title: Development of a Machine Learning-Based Risk Prediction Model and Stratified Management Strategies for Quality of Life in Lung Cancer Patients Undergoing Immunotherapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lung Cancer Patients
Keywords: HRQOL
lung cancer
immunotherapy
Lead sponsor: Second Affiliated Hospital of Zunyi Medical University
Sponsor class: OTHER
Collaborators: name: Ministry of Education of the People's Republic of China, Department of Humanities and Social Sciences
First posted: 2024-12-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A symptom cluster care intervention plan is being developed, and a research team is formed. Based on relevant literature and qualitative interviews, and guided by symptom management theory and the Knowledge-Attitude-Practice (KAP) behavior model, an initial draft of the care intervention plan is created and refined through expert consultation to finalize the plan.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this study is to explore whether health-related quality of life (HRQoL) can be used as a predictive indicator for lung cancer patients and to implement clinical interventions. The study addresses two main objectives:

Analyzing HRQoL data of lung cancer patients undergoing immunotherapy using machine learning clustering methods to explore data patterns and build an HRQoL early warning model (already developed).

Validating this HRQoL early warning model in real-world settings by classifying patients with different HRQoL characteristics and assessing the clinical value of the model

Detailed description: Lung cancer is the leading cause of cancer incidence and mortality in China, and it holds the same position in the United States. Non-small cell lung cancer (NSCLC) is the most common histological type, accounting for approximately 85% of lung cancer cases. Treatment strategies based on pathology, molecular subtyping, and clinical staging include surgery, radiotherapy, chemotherapy, targeted therapy, and immunotherapy. In recent years, immunotherapy has been extensively researched and applied in lung cancer treatment. It works by blocking the binding of PD-L1 on tumor cells to PD-1 on T cells, thereby releasing the inhibition of T cell function and killing the tumor cells. Immunotherapy has become the standard treatment for advanced NSCLC without driver mutations, and it covers the entire spectrum of non-surgical locally advanced NSCLC consolidation therapy, perioperative neoadjuvant, and adjuvant therapy for early-stage NSCLC. However, not all patients benefit from immunotherapy, with only a small subset experiencing clinical benefit. Therefore, identifying resistance mechanisms, selecting populations that benefit from treatment, and overcoming therapy resistance are complex and challenging clinical issues that require collaboration among basic, translational, and clinical oncology research teams.

In 1993, the World Health Organization (WHO) introduced the concept of Quality of Life (QoL), which refers to an individual's perception of their position in life within their cultural and value system, relating to their goals, expectations, standards, and concerns. Few studies focus on cancer patients' QoL, particularly those using patient-reported outcomes (PRO) as a primary endpoint. Most clinical trials for cancer drugs use PROs as secondary or exploratory endpoints. There is limited research that considers PROs as the primary endpoint. Therefore, it is essential to further investigate the relationship between cancer patients' health-related quality of life and prognosis, as well as its relevance to immunotherapy. This would facilitate better early identification of immune-related adverse events and systematic management, improving treatment adherence, QoL, and ensuring optimal treatment outcomes.

This project aims to develop a risk warning model for health-related quality of life in lung cancer patients receiving immunotherapy based on machine learning. By using cluster analysis, the study will clean, validate, and analyze the health-related quality of life data from the QLQ-C30 and QLQ-LC13 questionnaires from clinical trials available on the Vivli Global Clinical Research Data Sharing and Analysis Platform. The goal is to identify the distribution characteristics of these data and explore whether patient-reported outcomes can predict the efficacy of immunotherapy, thus serving as biomarkers to identify potential beneficiaries of immunotherapy. Furthermore, based on a risk warning and stratified management approach, the project aims to design appropriate symptom intervention strategies for different PRO types in immunotherapy patients, ultimately helping healthcare providers better understand the symptom burden that lung cancer patients may experience during immunotherapy and offering practical guidance for symptom management.

Eligibility criteria: Inclusion Criteria:

1. Histologically diagnosed with lung cancer
2. Age over 18 years
3. Currently receiving immunotherapy for lung cancer
4. Good verbal communication ability
5. Informed consent signed by the patient or family member

Exclusion Criteria:

1. Cognitive impairment or mental illness
2. Other severe diseases

Primary outcomes:
measure: EORTC QLQ C30
timeFrame: Two weeks after the intervention
measure: EORTC QLQ LC-13
timeFrame: Two weeks after the intervention
Secondary outcomes:
measure: ORR (Objective Response Rate)
timeFrame: Two weeks after the intervention
measure: PFS (Progression-Free Survival)
timeFrame: Two weeks after the intervention
Other outcomes:
Locations:
Study officials:
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