Reproductive Health Program in Patients With Cancer
Purpose
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.
Condition
- Malignant Neoplasm
Eligibility
- Eligible Ages
- Between 15 Years and 55 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Arm A (no intervention) |
Patients undergo usual standard practice related to reproductive health. |
|
|
Experimental Arm B (reproductive health program) |
Patients undergo reproductive health program comprising didactics, reproductive health assessment and navigating algorithm, and network development. |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- ECOG-ACRIN Cancer Research Group
Study Contact
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.