Reproductive Health Program in Patients With Cancer



Status:Recruiting
Healthy:No
Age Range:18 - 55
Updated:3/8/2019
Start Date:September 2015
End Date:November 2030

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EROS: Engendering Reproductive Health Within Oncologic Survivorship

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

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 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. OUTLINE: 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.

Inclusion Criteria:

Female patients presenting with initial diagnosis of any type of cancer (up to 3 months
after diagnosis, and if applicable, before initiation of chemotherapy or radiation)

Pre-menopausal patients within the reproductive age range

Pregnant women are eligible to participate in this study

Patients must have the cognitive ability to participate in the study

Patients must not have had a prior hysterectomy, bilateral oophorectomy or sterilization of
any method (including partner sterilization)
We found this trial at
1
site
Boston, Massachusetts 02215
Principal Investigator: Ashlesha A. Patel
Phone: 312-864-5935
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mi
from
Boston, MA
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