Study Protocol to Evaluate Influences of Stress and Inflammation on Mucositis in Adolescents and Young Adults With Cancer.

Background: Adolescent and young adult (AYA) cancer diagnoses are rising, and gains in survivorship are falling behind for this age group. Dose-limiting toxicities of therapy, including mucositis, are more frequent in this age group and may be contributing to poorer survivorship. Animal models and observational studies suggest that stress and inflammation may be contributing to the high prevalence of dose-limiting mucositis in this age demographic. The AYA oncology population has been an overlooked and underresearched oncology demographic, leading to poor understanding of why this age group has high side-effect burdens and poorer cancer survival.

Objectives: This article describes a novel, prospective clinical study in AYAs receiving chemotherapy designed to evaluate if stress at the time of chemotherapy administration predicts the development of dose-limiting mucositis and determines if stress-induced inflammatory profiles mediate this relationship. This is the first study to translate these stress and inflammation findings from animal models to a nurse-centered research design in humans.

Methods: Persons aged 15-39 years who are receiving chemotherapy with a significant (>20%) risk of developing mucositis will be recruited for a prospective study. Baseline stress is measured through participant questionnaires, and blood is collected to analyze for inflammatory markers. Participants receive chemotherapy as clinically planned and complete a daily survey of mucositis symptoms for 14 days after chemotherapy. Regression and mediation analysis will determine if stress and inflammatory profiles predict the development of dose-limiting mucositis.

Results: This model of inquiry through a nursing framework uses a biobehavioral model that considers physiological and psychological risk factors for chemotherapy toxicities. This study is also an important translational science study essential in bringing data from laboratory studies to the clinical arena. The study may also be important to implementation science because assessing the ability of critically ill individuals to participate in low-burden clinical studies may yield essential findings to improve care delivery.

Discussion: Findings from this work will identify potentially modifiable factors that may be manipulated to minimize chemotherapy toxicities and lead to improved survival. Data from this study will inform larger research endeavors to better understand symptom development in this high-risk oncological population.