Evaluation of a Telehealth Oncofertility Care Intervention in Adolescent and Young Adult Cancer Patients

Evaluation of a Telehealth Oncofertility Care Intervention in Adolescent and Young Adult Cancer Patients: a Stepped Wedge Cluster Randomized Controlled Trial

The purpose of this study is to evaluate the effectiveness of a multi-component intervention to improve young cancer survivors' engagement in goal-concordant oncofertility care, concurrently with observing and gathering information on how the intervention is implemented. The investigators hypothesize that implementation of the intervention will result in increased young cancer survivors' engagement in goal-concordant oncofertility care.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Fertility Preservation
• Intervention / Treatment: Behavioral: Multi-component oncofertility care intervention

• Study Type: Interventional
• Enrollment (Estimated): 2800
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: H. Irene Su, MD, MSCE; Phone Number: 858-822-5986; Email: hisu@health.ucsd.edu
• Study Contact Backup: Name: Sally AD Romero, PhD, MPH; Phone Number: 858-822-1371; Email: saromero@health.ucsd.edu

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010-3000
      • Recruiting
      • City of Hope
      • Contact: Saro Armenian, DO, MPH; Phone Number: 626-471-7320; Email: sarmenian@coh.org
      • Principal Investigator: Saro Armenian, DO, MPH
    • El Centro, California, United States, 92243
      • Active, not recruiting
      • Cancer Resource Center of the Desert
    • La Jolla, California, United States, 92093
      • Recruiting
      • University of California San Diego
      • Contact: H. Irene Su, MD, MSCE; Phone Number: 858-822-5986; Email: hisu@health.ucsd.edu
    • San Diego, California, United States, 92123
      • Recruiting
      • Rady Children's Hospital San Diego
      • Contact: Paula Aristizabal, MD, MAS; Phone Number: 858-966-5811; Email: paristizabal@rchsd.org
      • Principal Investigator: Paula Aristizabal, MD, MAS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Newly diagnosed cancer or cancer relapse
• Primary language English or Spanish
• Receiving oncology care at participating clinical sites
• Ages 0 to 42 years if female
• Ages 0 to 50 years if male

Exclusion Criteria:

• Non-melanoma skin cancer, because primary treatment is excision with no infertility risk
• Metastatic/Stage IV non-thyroid solid tumors, because of poor prognosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multi-component oncofertility care intervention; Eligible cancer patients presenting to oncology clinical visits will receive care through the multi-component oncofertility care intervention.	Behavioral: Multi-component oncofertility care intervention; The multi-component oncofertility care intervention includes: (1) an adaptive and smart default electronic health record-based oncofertility needs screen and referral pathway, (2) telehealth oncofertility counseling as indicated, and (3) telehealth oncofertility financial navigation as indicated.
No Intervention: Usual Care; Eligible cancer patients presenting to oncology clinical visits will receive usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of reproductive-aged female and male patients (aged 12 to 39 years) who engage in goal-concordant oncofertility care	The proportion of eligible reproductive-aged male and female patients (aged 12 to 39 years) who engage in oncofertility services (1| an oncofertility needs screen, 2| referral to oncofertility consult, 3| oncofertility consult, and/or 4| fertility preservation services) that meet the patient's individual needs will be abstracted from medical records using standardized case report forms.	12 weeks after oncology visit
Decisional Conflict	The 16-item Decisional Conflict Scale (DCS) will be used to measure patients' decisional conflict for engaging in fertility preservation services. The DCS consists of 16 statements with 5 response options (ranging from strongly agree to strongly disagree) that measures the patient's perceptions of uncertainty in choosing options, feeling informed, values clarity, support in decision making, and effective decision making. The DCS total score will be dichotomized at 37.5 (scale 0-100; > 37.5 indicates high decisional conflict).	12 weeks after oncology visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of female (aged 0 to 42 years) and male (aged 0 to 50 years) patients who engage in goal-concordant oncofertility care	The proportion of eligible female and male patients (aged 0 to 42 years for females; 0 to 50 years for males) who engage in oncofertility services [1) an oncofertility needs screen, 2) referral to oncofertility consult, 3) oncofertility consult, and/or 4) fertility preservation services] that meet the patient's individual needs will be abstracted from medical records using standardized case report forms.	12 weeks after oncology visit
Number of female patients (aged 0 to 42 years) who engage in goal-concordant oncofertility care	The proportion of eligible female patients (aged 0 to 42 years) who engage in oncofertility services [1) an oncofertility needs screen, 2) referral to oncofertility consult, 3) oncofertility consult, and/or 4) fertility preservation services] that meet the patient's individual needs will be abstracted from medical records using standardized case report forms.	12 weeks after oncology visit
Number of male patients (aged 0 to 50 years) who engage in goal-concordant oncofertility care	The proportion of eligible male patients (aged 0 to 50 years) who engage in oncofertility services [1) an oncofertility needs screen, 2) referral to oncofertility consult, 3) oncofertility consult, and/or 4) fertility preservation services] that meet the patient's individual needs will be abstracted from medical records using standardized case report forms.	12 weeks after oncology visit

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: City of Hope Medical Center; Rady Children's Hospital, San Diego
• Investigators: Principal Investigator: H. Irene Su, MD, MSCE, University of California, San Diego

Publications and helpful links

General Publications

• Romero SAD, Au L, Flores-Ortega RE, Helsten T, Palomino H, Kaiser BN, Echevarria M, Lukas K, Freeman K, Zou J, Aristizabal P, Armenian S, Su HI. 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 Jun;141:107537. doi: 10.1016/j.cct.2024.107537. Epub 2024 Apr 13.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: June 24, 2022
• First Submitted That Met QC Criteria: June 29, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Fertility preservation; Oncofertility; Adolescent and young adult cancer
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 800780

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual participant data generated during the study will be available from the principal investigator (H. Irene Su) upon reasonable request.
• IPD Sharing Time Frame: Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication.
• IPD Sharing Access Criteria: Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to the principal investigator (H. Irene Su).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No