Reproductive Health Program in Patients with Cancer
Hematopoietic Malignancies
Solid Tumor
E1Q11 (primary)
NCI-2012-02869
ECOG-E1Q11
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.
Eligibility
- Female patients presenting with initial diagnosis of any type of cancer, including patients with ductal breast carcinoma in situ (DCIS)
- Patients must be pre-menopausal patients within the reproductive age range
- Please note, pre-menopausal will be defined as women meeting the following criteria:
* Patients not currently on hormonal contraception with the presence of menses in the past 6 months
* If no menstruation in the past 6 months, without hormonal manipulation, then confirmed follicle-stimulating hormone (FSH) < 23 mlU/mL
* If age < 47 years and on hormonal contraception then patient will be eligible regardless of menstrual history
* If age >= 47 years and on hormonal contraception then FSH confirmed < 23 mIU/mL
- Pregnant women are eligible to participate in this study
- Patients must have the cognitive ability to participate in the study
Treatment Sites in Georgia
NGMC-Gainesville
Wisteria Building Suite 420
200 South Enota
Gainesville, GA 30501
770-219-8822
www.nghs.com
**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...
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