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

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

ArmDescriptionAssigned Intervention
Active Comparator
Arm A (no intervention)
Patients undergo usual standard practice related to reproductive health.
  • Other: Standard practice related to reproductive heath
    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.
  • Other: Training modules, algorithm, referral development
    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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.