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
Histologically diagnosed with lung cancer
Age over 18 years
Currently receiving immunotherapy for lung cancer
Good verbal communication ability
Cognitive impairment or mental illness
Other severe diseases
Parallel
Symptom cluster-based care intervention
BehavioralThe 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.
Conventional care intervention
BehavioralStandard 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
EORTC QLQ C30
The EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30) is a tool used to assess the quality of life in cancer patients. It consists of 30 items covering functioning, symptoms, and overall health status. Scores for each item range from 0 to 4 or 0 to 7 (depending on the item type), with overall scores typically ranging from 0 to 100. Higher scores indicate better quality of life with fewer symptoms and better functioning, while lower scores reflect worse quality of life with more severe symptoms and poorer functioning.
EORTC QLQ LC-13
The EORTC QLQ LC-13 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer Module 13) is a questionnaire used to assess the quality of life of lung cancer patients. It includes 13 items, with scores ranging from 0 to 4, and the total score ranges from 0 to 52. A higher score indicates more severe symptoms and poorer quality of life, while a lower score indicates better quality of life. The EORTC QLQ LC-13 is often used in conjunction with the EORTC QLQ-C30 scale, as they complement each other and provide a comprehensive assessment of the quality of life in lung cancer patients.
ORR (Objective Response Rate)
ORR refers to the proportion of patients who achieve either a complete response (CR) or partial response (PR) during treatment. This endpoint reflects the effectiveness of the treatment in controlling the tumor. It is typically assessed through imaging techniques (e.g., CT, MRI) and scored based on RECIST (Response Evaluation Criteria in Solid Tumors) or similar criteria. ORR is a common efficacy endpoint in cancer clinical trials.
PFS (Progression-Free Survival)
PFS refers to the length of time from the start of treatment until the tumor progresses or the patient dies, typically assessed through imaging or clinical evaluation. This endpoint reflects the effectiveness of the treatment in delaying disease progression. PFS is particularly useful in evaluating the clinical efficacy of new drugs or therapies. An extension of PFS is usually considered a sign of effective treatment.
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Second Affiliated Hospital of Zunyi Medical University
Lead sponsor
Ministry of Education of the People's Republic of China, Department of Humanities and Social Sciences
Collaborator
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