NCT01806129

Reproductive Health Program in Patients With Cancer

EROS: Engendering Reproductive Health Within Oncologic Survivorship

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 434 (actual)
• Sponsor: ECOG-ACRIN Cancer Research Group · Network
• Sex: Female
• Age: 15 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 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. 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: Participating institutions are randomized to 1 of 2 arms. Patients are assigned to a study arm depending on the institutional assignment. 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 intervention, patients are followed up periodically.

Conditions

• Malignant Neoplasm

Interventions

Type	Name	Description
OTHER	Standard practice related to reproductive heath	Patients undergo usual standard practice related to reproductive health.
OTHER	Training modules, algorithm, referral development	Patients undergo reproductive health program comprising didactics, reproductive health assessment and navigating algorithm, and network development.

Timeline

• Start date: 2016-09-02
• Primary completion: 2021-07-31
• Completion: 2025-12-30
• First posted: 2013-03-07
• Last updated: 2025-06-13
• Results posted: 2022-10-05

Locations

109 sites across 1 country: United States