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

NCT ID: NCT05443737

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

2800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2027-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer Fertility Preservation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Stepped wedge cluster randomized controlled trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers
Fertility specialists and their support staff will be blinded to the intervention status of the cluster from which a patient is referred to minimize differences in counseling in patients whom they expect to receive financial navigation.

Study Groups

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Multi-component oncofertility care intervention

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

Group Type EXPERIMENTAL

Multi-component oncofertility care intervention

Intervention Type BEHAVIORAL

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.

Usual Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rady Children's Hospital, San Diego

OTHER

Sponsor Role collaborator

City of Hope Medical Center

OTHER

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Hui-Chun Irene Su

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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H. Irene Su, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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City of Hope

Duarte, California, United States

Site Status RECRUITING

Cancer Resource Center of the Desert

El Centro, California, United States

Site Status ACTIVE_NOT_RECRUITING

University of California San Diego

La Jolla, California, United States

Site Status RECRUITING

Rady Children's Hospital San Diego

San Diego, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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H. Irene Su, MD, MSCE

Role: CONTACT

858-822-5986

Sally AD Romero, PhD, MPH

Role: CONTACT

858-822-1371

Facility Contacts

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Saro Armenian, DO, MPH

Role: primary

626-471-7320

H. Irene Su, MD, MSCE

Role: primary

858-822-5986

Paula Aristizabal, MD, MAS

Role: primary

858-966-5811

References

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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.

Reference Type DERIVED
PMID: 38614445 (View on PubMed)

Other Identifiers

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800780

Identifier Type: -

Identifier Source: org_study_id

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