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

Part of paid clinical trials in Duarte, California.

Sponsor
University of California, San Diego
Study ID
NCT05443737
Phase
PHASE3
Status
Recruiting

Conditions

  • Cancer
  • Fertility Preservation

Eligibility Criteria

Sex
ALL
Age
0 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Multi-component oncofertility care intervention — 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.

Study Details

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.

Key Dates

Start date
Jan 1, 2022
Status verified
Nov 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
2,800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE

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.

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 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-3000
Saro Armenian, DO, MPH
626-471-7320
Saro Armenian, DO, MPH (PRINCIPAL_INVESTIGATOR)
Cancer Resource Center of the DesertEl CentroCalifornia92243-
University of California San DiegoLa JollaCalifornia92093
H. Irene Su, MD, MSCE
858-822-5986
Rady Children's Hospital San DiegoSan DiegoCalifornia92123
Paula Aristizabal, MD, MAS
858-966-5811
Paula Aristizabal, MD, MAS (PRINCIPAL_INVESTIGATOR)

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