A multiphase study protocol of identifying, and predicting cancer-related symptom clusters: applying a mixed-method design and machine learning algorithms.

Objectives: In recent years, there has been increasing attention on the cluster approach to symptom management. Two significant challenges in the symptom cluster (SC) approach are identifying and predicting these clusters. This multiphase protocol aims to identify SCs in patients with advanced cancer as the primary objective, with the secondary objective of developing machine learning algorithms to predict SCs identified in the first phase. Methods: The 2-MIXIP study consists of two main phases. The first phase involves identifying SCs, and the second phase focuses on developing predictive algorithms for the identified SCs. The identification of SCs involves a parallel mixed-method design (quantitative and qualitative). Quantitative and qualitative methods are conducted simultaneously and given equal importance. The data are collected and analyzed independently before being integrated. The quantitative part is conducted using a descriptive-analytical method. The qualitative analysis is conducted using a content analysis approach. Then, the identified SCs from both parts are integrated to determine the final clusters and use them in the second phase. In the second phase, we employ a tree-based machine learning method to create predictive algorithms for SCs using key demographic and clinical patient characteristics. Conclusion: The findings of the 2-MIXIP study can help manage cancer patients' symptoms more effectively and enhance clinical decision-making by using SCs prediction. Furthermore, the results of this study can provide guidance for clinical trials aimed at managing symptoms.