Actively Recruiting

Phase 3
Age: 0Years - 50Years
All Genders
ID05443737

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

Led by University of California, San Diego · Updated on 2025-12-03

2800

Participants Needed

4

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of California, San Diego

Lead Sponsor

R

Rady Children's Hospital, San Diego

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a multi-component telehealth intervention designed to improve engagement in goal-aligned oncofertility care among adolescent and young adult cancer patients. The study focuses on young cancer survivors and aims to observe how the intervention is implemented while assessing its impact on their participation in fertility preservation care. This is a phase 3 randomized controlled trial sponsored by the University of California, San Diego. The intervention group receives a multi-component telehealth oncofertility care program that includes an adaptive electronic health record-based screening and referral system, telehealth counseling, and financial navigation when needed. The control group receives usual oncology care without the added oncofertility intervention. Eligible cancer patients are assigned randomly to either group as they present to oncology visits. Participants aged from newborns up to 50 years old will be followed, with key outcomes measured 12 weeks after their oncology visit. Researchers will assess how many patients engage in goal-concordant oncofertility care and measure decisional conflict related to fertility choices. The study monitors both male and female patients, with assessments including engagement rates and decision-making clarity regarding fertility preservation options.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - Up to 12 weeks after oncology visit

Participants receive the multi-component oncofertility care intervention including telehealth counseling and financial navigation as indicated.

Oncology clinical visits with telehealth as scheduled

Trial Site Locations

Total: 4 locations

1

City of Hope

Duarte, California, United States, 91010-3000

Actively Recruiting

2

Cancer Resource Center of the Desert

El Centro, California, United States, 92243

Active, Not Recruiting

3

University of California San Diego

La Jolla, California, United States, 92093

Actively Recruiting

4

Rady Children's Hospital San Diego

San Diego, California, United States, 92123

Actively Recruiting

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Research Team

H

H. Irene Su, MD, MSCE

S

Sally AD Romero, PhD, MPH

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

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...

https://pubmed.ncbi.nlm.nih.gov/38614445