Machine Learning for Predicting and Managing Quality of Life in Lung Cancer Immunotherapy Patients

NCT ID: NCT06725225

Last Updated: 2024-12-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2026-04-01

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.

Conditions

Lung Cancer Patients

Keywords

HRQOL; lung cancer; immunotherapy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

The group with milder symptoms and better quality of life

the group uses unsupervised machine learning to identify patients with severe symptoms and poor functionality who are receiving immunotherapy for non-small cell lung cancer, and implements a symptom cluster care intervention.

Group Type: PLACEBO_COMPARATOR

Conventional care intervention

Intervention Type: BEHAVIORAL

Standard nursing intervention. This refers to routine clinical care without a specific care plan tailored to the patient's symptoms. For example, if a patient has symptoms, the nurse assists the patient in notifying the doctor but does not provide any special treatment themselves

The group with more severe symptoms and poorer quality of life

Group Type: ACTIVE_COMPARATOR

Symptom cluster-based care intervention

Intervention Type: BEHAVIORAL

The patient symptoms were surveyed to develop a symptom cluster care intervention plan. The specific steps were as follows: a research team was established, relevant literature was reviewed, and qualitative interviews were conducted. Guided by symptom management theory and the Knowledge-Attitude-Practice (KAP) behavior model, a draft of the care intervention was created. This draft was then refined through expert consultation to finalize the intervention plan.

Interventions

Symptom cluster-based care intervention

The patient symptoms were surveyed to develop a symptom cluster care intervention plan. The specific steps were as follows: a research team was established, relevant literature was reviewed, and qualitative interviews were conducted. Guided by symptom management theory and the Knowledge-Attitude-Practice (KAP) behavior model, a draft of the care intervention was created. This draft was then refined through expert consultation to finalize the intervention plan.

Intervention Type: BEHAVIORAL

Conventional care intervention

Standard nursing intervention. This refers to routine clinical care without a specific care plan tailored to the patient's symptoms. For example, if a patient has symptoms, the nurse assists the patient in notifying the doctor but does not provide any special treatment themselves

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Education of the People's Republic of China, Department of Humanities and Social Sciences

UNKNOWN

Sponsor Role: collaborator

Second Affiliated Hospital of Zunyi Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jian-Guo Zhou, MD, PhD

associate professor and associate chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Jianguo zhou

Role: CONTACT

Phone: +8618311543939

Email: jianguo.zhou@yahoo.com

Study Documents

Document Type: Individual Participant Data Set

View Document

Other Identifiers

24YJCZH462

Identifier Type: -

Identifier Source: org_study_id