EROS: Engendering Reproductive Health within Oncologic Survivorship
Trial Overview
| Acronym | EROS |
|---|---|
| Number | NCT01806129 |
| Protocol Link | https://clinicaltrials.gov/show/NCT01806129 |
| Public Trial Registry Link | https://clinicaltrials.gov/ct2/show/NCT01806129?term=EROS&recr=Open&titles=EROS&rank=1 |
| Status | Open/recruiting |
| Category | Miscellaneous |
| Treatment Course | Adjuvant, palliative or post-op |
Trial Description
| This randomized clinical trial studies a reproductive health program in patients with cancer. A reproductive health program may improve patients’ understanding of reproductive risks and receipt of appropriate treatment to achieve their reproductive health goals. |
Chief Investigator
|
Ashlesha A. Patel Mr |
| Profile Link |
Lead Centre
|
Eastern Cooperative Oncology Group . Boston 02215 USA |
| Website |
Additional Information
Full Research Summary| Objective: | PRIMARY OBJECTIVES: I. To evaluate the success of the implementation of reproductive health programming (Didactics, Engendering Reproductive Health Within Oncologic Survivorship [EROS] Reproductive Health Assessment and EROS Trial Algorithm) among reproductive aged women (18-55) with cancer. SECONDARY SECONDARY OBJECTIVES: I. To assess the degree of discrepancy between patients and their clinicians in estimates of significance of the reproductive health goals for the patient. II. To evaluate baseline and follow-up reproductive health assessments for trends in reproductive health choices relating to oncofertility, oncocontraception and pregnancy over the 5 year study period. III. To identify clinical and demographic factors that predict the adequacy of reproductive health care management. TERTIARY OBJECTIVES: I. To perform a longitudinal study following endocrine markers of fertility in a cohort of the first 200 registered EROS trial patients who agree to participate. II. To perform a longitudinal study of sexual function using the Patient-Reported Outcomes Measurement Information System (PROMIS) sexual function survey in all subjects participating in the EROS Trial. |
| Aim: | This clinical trial studies reproductive health program in patients with cancer. A reproductive health program may improve patients' understanding of reproductive risks and receipt of appropriate treatment to achieve their reproductive health goals |
| Methods: | Patients are randomized to 1 of 2 arms. ARM A: Patients undergo usual standard practice related to reproductive health. ARM B: Patients undergo reproductive health program comprising didactics, reproductive health assessment and navigating algorithm, and network development. After completion of study treatment, patients are followed up periodically. |
| Reason for International Trial: | . |