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EROS: Engendering Reproductive Health within Oncologic Survivorship

Status
Active
Cancer Type
Unknown Primary
Trial Phase
Eligibility
18 to 55, Female
Study Type
Biomarker/Laboratory analysis
Natural history/Epidemiology
Supportive care
NCT ID
NCT01806129
Protocol IDs
E1Q11 (primary)
NCI-2012-02869
ECOG-E1Q11
Study Sponsor
ECOG-ACRIN Cancer Research Group

Summary

TRIAL STATUS: Active

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.

Objectives

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 at 3, 6, 12, 24, 36, 48, and 60 months.

Treatment Sites in Georgia

Harbin Clinic Cancer Center


255 West Fifth Street
Rome, GA 30165
706-528-9110
www.harbinclinic.com

Northeast Georgia Medical Center - Gainesville


NGMC-Gainesville
Wisteria Building Suite 420
200 South Enota
Gainesville, GA 30501
770-219-8822
www.nghs.com

Piedmont Columbus Regional


1831 5th Ave
Columbus, GA 31901
www.columbusregional.com

Study Coordinator:
Jay Pitts, BS, CPhT
706-596-5426

Doctors:

Sajid Ahmed MD
Wilbur B. Bassett, Jr. MD
Andrew W. Pippas MD
Peter Q. Jiang MD
Suresh Nukala MD
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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