Recruiting
Phase 3

Telehealth Oncofertility

Sponsor:

UCLA

Code:

NCT05443737

Conditions

Cancer

Fertility Preservation

Eligibility Criteria

Sex: All

Age: 0 - 50

Healthy Volunteers: Not accepted

Interventions

Multi-component oncofertility care intervention

Study Details

Brief summary:

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.

Conditions

Cancer

Fertility Preservation

Study ID

NCT05443737

Start date

Jan 1, 2022

Status verified date

Nov, 2025

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 50

Healthy Volunteers: Not accepted

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 Design

Enrollment

2800 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Multi-component oncofertility care intervention

Eligible cancer patients presenting to oncology clinical visits will receive care through the multi-component oncofertility care intervention.

no intervention: Usual Care

Eligible cancer patients presenting to oncology clinical visits will receive usual care.

Interventions

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.

Primary outcome measure

  • Number of reproductive-aged female and male patients (aged 12 to 39 years) who engage in goal-concordant oncofertility care [ Time Frame: 12 weeks after oncology visit ]
  • Decisional Conflict [ Time Frame: 12 weeks after oncology visit ]

Central Contacts and Locations

Central contacts

H. Irene Su, MD, MSCE

858-822-5986hisu@health.ucsd.edu

Sally AD Romero, PhD, MPH

858-822-1371saromero@health.ucsd.edu

Locations

City of Hope

Recruiting

Duarte, California, United States, 91010-3000

Contacts

Saro Armenian, DO, MPH

626-471-7320sarmenian@coh.org

Principal Investigator:

Saro Armenian, DO, MPH

University of California San Diego

Recruiting

La Jolla, California, United States, 92093

Contacts

H. Irene Su, MD, MSCE

858-822-5986hisu@health.ucsd.edu

Rady Children's Hospital San Diego

Recruiting

San Diego, California, United States, 92123

Contacts

Paula Aristizabal, MD, MAS

858-966-5811paristizabal@rchsd.org

Principal Investigator:

Paula Aristizabal, MD, MAS

More Information

Sponsor

University of California, San Diego

Last update posted

Dec 3, 2025

Last verified

Nov, 2025

Keywords

  • Oncofertility
  • Fertility preservation
  • Adolescent and young adult cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2025-12-03.