Evaluation of a Telehealth Oncofertility Care Intervention in Adolescent and Young Adult Cancer Patients
1 other identifier
interventional
2,800
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 cancer
Started Jan 2022
Longer than P75 for phase_3 cancer
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2022
CompletedFirst Submitted
Initial submission to the registry
June 24, 2022
CompletedFirst Posted
Study publicly available on registry
July 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
December 3, 2025
November 1, 2025
5.7 years
June 24, 2022
November 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
Number of female (aged 0 to 42 years) and male (aged 0 to 50 years) patients who engage in goal-concordant oncofertility care
12 weeks after oncology visit
Number of female patients (aged 0 to 42 years) who engage in goal-concordant oncofertility care
12 weeks after oncology visit
Number of male patients (aged 0 to 50 years) who engage in goal-concordant oncofertility care
12 weeks after oncology visit
Study Arms (2)
Multi-component oncofertility care intervention
EXPERIMENTALEligible cancer patients presenting to oncology clinical visits will receive care through the multi-component oncofertility care intervention.
Usual Care
NO INTERVENTIONEligible cancer patients presenting to oncology clinical visits will receive usual care.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Non-melanoma skin cancer, because primary treatment is excision with no infertility risk
- Metastatic/Stage IV non-thyroid solid tumors, because of poor prognosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Diegolead
- Rady Children's Hospital, San Diegocollaborator
- City of Hope Medical Centercollaborator
Study Sites (4)
City of Hope
Duarte, California, 91010-3000, United States
Cancer Resource Center of the Desert
El Centro, California, 92243, United States
University of California San Diego
La Jolla, California, 92093, United States
Rady Children's Hospital San Diego
San Diego, California, 92123, United States
Related Publications (1)
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.
PMID: 38614445DERIVED
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
H. Irene Su, MD, MSCE
University of California, San Diego
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Masking Details
- 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.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 24, 2022
First Posted
July 5, 2022
Study Start
January 1, 2022
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
August 31, 2027
Last Updated
December 3, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication.
- 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).
Deidentified individual participant data generated during the study will be available from the principal investigator (H. Irene Su) upon reasonable request.