Let's TOC Fertility: A stepped wedge cluster randomized controlled trial of the Telehealth Oncofertility Care (TOC) intervention in children, adolescent and young adult cancer survivors

Sally A D Romero; Lauren Au; Ricardo E Flores-Ortega; Teresa Helsten; Helen Palomino; Bonnie N Kaiser; Meagan Echevarria; Kara Lukas; Kendall Freeman; Jingjing Zou; Paula Aristizabal; Saro Armenian; H Irene Su

doi:10.1016/j.cct.2024.107537

Let's TOC Fertility: A stepped wedge cluster randomized controlled trial of the Telehealth Oncofertility Care (TOC) intervention in children, adolescent and young adult cancer survivors

Contemp Clin Trials. 2024 Apr 13:141:107537. doi: 10.1016/j.cct.2024.107537. Online ahead of print.

Authors

Affiliations

¹ Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Diego, School of Medicine, United States of America; Herbert Wertheim School of Public Health and Human Longevity Science, University of California at San Diego, United States of America. Electronic address: saromero@health.ucsd.edu.
² Department of Medicine, University of Hawai'i at Mānoa John A Burns School of Medicine, United States of America.
³ Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Diego, School of Medicine, United States of America.
⁴ Department of Medicine, University of California San Diego, School of Medicine, United States of America; Moores Cancer Center, University of California San Diego, United States of America.
⁵ Cancer Resource Center of the Desert, United States of America.
⁶ Department of Anthropology and Global Health Program, University of California San Diego, United States of America.
⁷ City of Hope Comprehensive Cancer Center, United States of America.
⁸ Herbert Wertheim School of Public Health and Human Longevity Science, University of California at San Diego, United States of America.
⁹ Moores Cancer Center, University of California San Diego, United States of America; Department of Pediatrics, University of California San Diego, School of Medicine, United States of America.
¹⁰ Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Diego, School of Medicine, United States of America; Moores Cancer Center, University of California San Diego, United States of America.

PMID: 38614445
DOI: 10.1016/j.cct.2024.107537

Abstract

Introduction: Children, adolescent, and young adult cancer survivors experience overall increased risks of infertility that are preventable through effective fertility preservation services prior to starting cancer treatment. Oncofertility care is the evidence-based practice of informing newly diagnosed cancer patients about their reproductive risks and supporting shared decision-making on fertility preservation services. Despite longstanding clinical guidelines, oncofertility care delivery continues to be limited and highly variable across adult and pediatric oncology settings.

Materials and methods: We describe the design of a stepped wedge cluster randomized clinical trial to evaluate the effectiveness of the multi-component Telehealth Oncofertility Care (TOC) intervention conducted in 20 adult and pediatric oncology clinics across three health systems in Southern California. Intervention components are: 1) electronic health record-based oncofertility needs screen and referral pathway to a virtual oncofertility hub; 2) telehealth oncofertility counseling through the hub; and 3) telehealth oncofertility financial navigation through the hub. We hypothesize the intervention condition will be associated with increased proportions of patients who engage in goal-concordant oncofertility care (i.e., engagement in reproductive risk counseling and fertility preservation services that meet the patient's fertility goals) and improved patient-reported outcomes, compared to the usual care control condition. We will also evaluate intervention implementation in a mixed-methods study guided by implementation science frameworks.

Discussion: Our overall goal is to speed implementation of a scalable oncofertility care intervention at cancer diagnosis for children, adolescent and young adult cancer patients to improve their future fertility and quality of life.

Trial registration: Clinicaltrials.gov Identifier: NCT05443737.

Keywords: Adolescent and young adult; Children; Oncofertility; Telehealth.

Associated data

ClinicalTrials.gov/NCT05443737