EROS: Engendering Reproductive Health Within Oncologic Survivorship
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Malignant Neoplasm
- Sponsor
- ECOG-ACRIN Cancer Research Group
- Enrollment
- 434
- Locations
- 109
- Primary Endpoint
- Proportion of Patients With Appropriate Reproductive Health Management
- Status
- Active, Not Recruiting
- Last Updated
- 10 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Female patients presenting with initial diagnosis of any type of cancer, including patients with ductal carcinoma in situ (DCIS)
- •Pre-menopausal patients within the reproductive age range of 15-55 years; pre-menopausal is defined as females 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) \< 23mlU/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 \< 23mIU/mL
- •Pregnant women are eligible to participate in this study
- •Patients must have the cognitive ability to participate in the study
Exclusion Criteria
- •Patients who have initiated chemotherapy, radiation therapy or endocrine therapy prior to registration to this study
- •Prior hysterectomy, bilateral oophorectomy or sterilization of any method
Outcomes
Primary Outcomes
Proportion of Patients With Appropriate Reproductive Health Management
Time Frame: At baseline and 3 months
Appropriate reproductive health management was determined using the followings: (1) Females that were pregnant or interested in immediate pregnancy (defined as within 1 year of enrollment) were given referral to obstetrician/gynecologist or counseled about pregnancy options (2) Females interested in future childbearing were counseled or given a referral for fertility preservation if requested (3) Females who were not interested in immediate pregnancy were given a referral or counseling to select family planning that was consistent with plans for sexual activity and future childbearing. If a female fell into category 1, 2, or 3, and the appropriate referral occurred within 3 months of enrollment, then appropriate reproductive health management was achieved. For patients with appropriate reproductive health management in place before the baseline visit, they were included in the analysis and counted as having appropriate reproductive health management.
Secondary Outcomes
- Difference in Rating Between Patients and Their Clinicians in Importance of Fertility Maintenance(At baseline)
- The Changes in Reproductive Health Status From Baseline to 3 Months(Baseline and 3 months)
- Associations Between Clinical and Demographic Factors and Adequacy of Reproductive Health Care Management(Baseline and 3 months)