Telehealth support for young cancer patients to preserve fertility
Evaluation of a Telehealth Oncofertility Care Intervention in Adolescent and Young Adult Cancer Patients: a Stepped Wedge Cluster Randomized Controlled Trial
This study tests a new telehealth program to see if it helps young cancer patients get better support and information about preserving their fertility.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 2800 (estimated) |
| Ages | 0 Years to 50 Years |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 4 sites (Duarte, California and 3 other locations) |
| Trial ID | NCT05443737 on ClinicalTrials.gov |
What this trial studies
This study evaluates a multi-component telehealth intervention designed to enhance engagement in oncofertility care among adolescent and young adult cancer patients. The intervention aims to provide tailored support and resources to help these patients make informed decisions regarding fertility preservation. By observing the implementation of this intervention, the study seeks to determine its effectiveness in improving patient outcomes in oncofertility care. The researchers hypothesize that increased engagement will lead to better alignment with patients' fertility goals.
Who should consider this trial
Good fit: Ideal candidates include newly diagnosed cancer patients or those experiencing a cancer relapse, aged 0 to 42 years for females and 0 to 50 years for males.
Not a fit: Patients with non-melanoma skin cancer or metastatic/Stage IV non-thyroid solid tumors may not benefit from this study due to the nature of their treatment and prognosis.
Why it matters
Potential benefit: If successful, this intervention could significantly improve fertility preservation options and outcomes for young cancer survivors.
How similar studies have performed: Other studies have shown promise in using telehealth interventions for similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Duarte, California and 3 other locations
- City of Hope — Duarte, California, United States (Recruiting)
- Cancer Resource Center of the Desert — El Centro, California, United States (Active_not_recruiting)
- University of California San Diego — La Jolla, California, United States (Recruiting)
- Rady Children's Hospital San Diego — San Diego, California, United States (Recruiting)
Study contacts
- Principal investigator: H. Irene Su, MD, MSCE — University of California, San Diego
- Study coordinator: H. Irene Su, MD, MSCE
- Email: hisu@health.ucsd.edu
- Phone: 858-822-5986
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.