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EROS: Engendering Reproductive Health Within Oncologic Survivorship


N/A
18 Years
55 Years
Not Enrolling
Female
Malignant Neoplasm

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Trial Information

EROS: Engendering Reproductive Health Within Oncologic Survivorship


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 women
(18-55) 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 5 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: Patients are randomized to 1 of 2 arms. 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 treatment, patients are
followed up periodically.


Inclusion Criteria:



Female patients presenting with initial diagnosis of any type of cancer (up to 3 months
after diagnosis, and if applicable, before initiation of chemotherapy or radiation)

Pre-menopausal patients within the reproductive age range

Pregnant women are eligible to participate in this study

Patients must have the cognitive ability to participate in the study

Patients must not have had a prior hysterectomy, bilateral oophorectomy or sterilization
of any method (including partner sterilization)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Adoption of appropriate reproductive health management consistent with initial reproductive health goals of the patient based on success of the EROS Trial Algorithm as a tool

Outcome Description:

The consistency rate of reproductive health management at each time point will be summarized, by arm, with frequency and percentage along with its 95% confidence interval.

Outcome Time Frame:

Within 3 months of enrollment

Safety Issue:

No

Principal Investigator

Ashlesha Patel

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eastern Cooperative Oncology Group

Authority:

United States: Institutional Review Board

Study ID:

E1Q11

NCT ID:

NCT01806129

Start Date:

March 2013

Completion Date:

Related Keywords:

  • Malignant Neoplasm
  • Neoplasms

Name

Location
Eastern Cooperative Oncology Group Boston, Massachusetts  02215