Evaluation of a Telehealth Oncofertility Care Intervention in Adolescent and Young Adult Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multi-component oncofertility care intervention.
- Who it may be relevant to
- Registry conditions: Cancer, Fertility Preservation. Basic parameters: 0 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of a Telehealth Oncofertility Care Intervention in Adolescent and Young Adult Cancer Patients: a Stepped Wedge Cluster Randomized Controlled Trial
Overview
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.
Interventions
- 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.
Primary outcome measures
- 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]
Secondary outcome measures (3)
- Number of female (aged 0 to 42 years) and male (aged 0 to 50 years) patients who engage in goal-concordant oncofertility care [Time frame: 12 weeks after oncology visit]
- Number of female patients (aged 0 to 42 years) who engage in goal-concordant oncofertility care [Time frame: 12 weeks after oncology visit]
- Number of male patients (aged 0 to 50 years) who engage in goal-concordant oncofertility care [Time frame: 12 weeks after oncology visit]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 4 centers
- City of Hope — Duarte
- Cancer Resource Center of the Desert — El Centro
- University of California San Diego — La Jolla
- Rady Children's Hospital San Diego — San Diego
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.2024.10 PMID 38614445
Identifiers
NCT: NCT05443737 · 800780