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Reproductive Health Program in Patients with Cancer


Active: No
Cancer Type: Hematopoietic Malignancies
Solid Tumor
NCT ID: NCT01806129
Trial Phases: Protocol IDs: E1Q11 (primary)
NCI-2012-02869
ECOG-E1Q11
Eligibility: 15 - 55 Years, Female Study Type: Supportive care
Study Sponsor: ECOG-ACRIN Cancer Research Group
NCI Full Details: http://clinicaltrials.gov/show/NCT01806129

Summary

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 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.

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:




**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.