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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01806129.
PRIMARY OBJECTIVE:
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 females (15-55) 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 2 year study period.
III. To identify clinical and demographic factors that predict the adequacy of reproductive health care management.
CORRELATIVES OBJECTIVE:
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.
QUALITY OF LIFE OBJECTIVE:
I. 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: Participating sites are randomized to 1 of 2 arms. Patients are assigned to arms based on participating site.
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, patients are followed up at 3, 6, 12, and 24 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationECOG-ACRIN Cancer Research Group
Principal InvestigatorAshlesha A. Patel