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Reproductive Health Program i...

Reproductive Health Program in Patients With Cancer

Last Updated: 2025-06-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

Total Enrollment

434 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-02

Study Completion Date

2025-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Malignant Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arm A (no intervention)

Patients undergo usual standard practice related to reproductive health.

Group Type ACTIVE_COMPARATOR

Standard practice related to reproductive heath

Intervention Type OTHER

Patients undergo usual standard practice related to reproductive health.

Arm B (reproductive health program)

Patients undergo reproductive health program comprising didactics, reproductive health assessment and navigating algorithm, and network development.

Group Type EXPERIMENTAL

Training modules, algorithm, referral development

Intervention Type OTHER

Patients undergo reproductive health program comprising didactics, reproductive health assessment and navigating algorithm, and network development.

Interventions

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Standard practice related to reproductive heath

Patients undergo usual standard practice related to reproductive health.

Intervention Type OTHER

Training modules, algorithm, referral development

Patients undergo reproductive health program comprising didactics, reproductive health assessment and navigating algorithm, and network development.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ashlesha Patel

Role: PRINCIPAL_INVESTIGATOR

Eastern Cooperative Oncology Group

Locations

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Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, United States

Site Status

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

Site Status

Cancer Center of Colorado at Sloan's Lake

Denver, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Sky Ridge

Lone Tree, Colorado, United States

Site Status

SCL Health Lutheran Medical Center

Wheat Ridge, Colorado, United States

Site Status

Augusta University Medical Center

Augusta, Georgia, United States

Site Status