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 — BEHAVIORALThe 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 interventionEligible cancer patients presenting to oncology clinical visits will receive care through the multi-component oncofertility care intervention.
- No Intervention: Usual CareEligible 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
- H. Irene Su, MD, MSCE858-822-5986
- Sally AD Romero, PhD, MPH858-822-1371
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| City of Hope | Duarte | California | 91010-3000 | Saro Armenian, DO, MPH (PRINCIPAL_INVESTIGATOR) |
| Cancer Resource Center of the Desert | El Centro | California | 92243 | - |
| University of California San Diego | La Jolla | California | 92093 | |
| Rady Children's Hospital San Diego | San Diego | California | 92123 | Paula Aristizabal, MD, MAS (PRINCIPAL_INVESTIGATOR) |
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