Reproductive Health Program in Patients With Cancer (EROS)

ECOG-ACRIN Cancer Research Group

Status

Active, not recruiting

Conditions

Malignant Neoplasm

Treatments

Other: Training modules, algorithm, referral development

Other: Standard practice related to reproductive heath

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT01806129

U10CA037403 (U.S. NIH Grant/Contract)

NCI-2012-02869 (Registry Identifier)

E1Q11

Details and patient eligibility

About

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.

Full 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.

Enrollment

434 patients

Sex

Female

Ages

15 to 55 years old

Volunteers

No Healthy Volunteers

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