Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
612

Summary

Conditions
Malignant Neoplasm
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 55 years
Gender
Only males

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 women (18-55) with cancer. SECONDA...

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.

Tracking Information

NCT #
NCT01806129
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Ashlesha Patel Eastern Cooperative Oncology Group