Any Cancer, Reproductive Health

E1Q11 / EROS



Reproductive Health Program in Patients with Cancer

STATUS: Closed to Accrual


This randomized clinical trial studies a reproductive health program in patients with cancer. A reproductive health program may improve patientsโ€™ understanding of reproductive risks and receipt of appropriate treatment to achieve their reproductive health goals.
  • Female patients presenting with initial diagnosis of any type of cancer, including patients with ductal breast carcinoma in situ (DCIS)

  • Patients must not have initiated chemotherapy, radiation therapy or endocrine therapy prior to registration to this study

  • Patients must not have had a prior hysterectomy, bilateral oophorectomy or sterilization of any method

  • Patients must be pre-menopausal patients within the reproductive age range

  • Please note, pre-menopausal will be defined as women 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) < 23 mlU/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 < 23 mIU/mL

  • Pregnant women are eligible to participate in this study

  • Patients must have the cognitive ability to participate in the study

United States
AR
Jonesboro
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Contact: Site Public Contact
Email: Emily.Carvell@bmhcc.org

CO
Aurora
Rocky Mountain Cancer Centers-Aurora
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Boulder
Rocky Mountain Cancer Centers-Boulder
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Denver
Cancer Center of Colorado at Sloan's Lake
Contact: Site Public Contact

Lone Tree
Rocky Mountain Cancer Centers-Sky Ridge
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Wheat Ridge
SCL Health Lutheran Medical Center
Contact: Site Public Contact
Email: ccrp@co-cancerresearch.org

GA
Augusta
Augusta University Medical Center
Contact: Site Public Contact
Email: ga_cares@augusta.edu

Columbus
John B Amos Cancer Center
Contact: Site Public Contact
Email: cdean@iacthealth.com

HI
Aiea
Pali Momi Medical Center
Contact: Site Public Contact

Honolulu
Hawaii Cancer Care Inc - Waterfront Plaza
Contact: Site Public Contact
Email: i.webster@hawaiicancercare.com

Kapiolani Medical Center for Women and Children
Contact: Site Public Contact

Queen's Cancer Cenrer - POB I
Contact: Site Public Contact

Queen's Cancer Center - Kuakini
Contact: Site Public Contact

Queen's Medical Center
Contact: Site Public Contact

Straub Clinic and Hospital
Contact: Site Public Contact

Tripler Army Medical Center
Contact: Site Public Contact

University of Hawaii Cancer Center
Contact: Site Public Contact

IA
Clive
Medical Oncology and Hematology Associates-West Des Moines
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org

Mercy Cancer Center-West Lakes
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org

Creston
Greater Regional Medical Center
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org

Des Moines
Mercy Medical Center - Des Moines
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org

Mission Cancer and Blood - Laurel
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org

West Des Moines
Mercy Medical Center-West Lakes
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org

IL
Chicago
John H Stroger Jr Hospital of Cook County
Contact: Site Public Contact

Danville
Carle at The Riverfront
Contact: Site Public Contact
Email: Research@carle.com

Effingham
Carle Physician Group-Effingham
Contact: Site Public Contact
Email: Research@carle.com

Mattoon
Carle Physician Group-Mattoon/Charleston
Contact: Site Public Contact
Email: Research@carle.com

Urbana
Carle Cancer Center
Contact: Site Public Contact
Email: Research@carle.com

The Carle Foundation Hospital
Contact: Site Public Contact
Email: Research@carle.com

KY
Lexington
Saint Joseph Hospital East
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org

London
Saint Joseph London
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org

LA
Monroe
Ochsner LSU Health Monroe Medical Center
Contact: Site Public Contact
Email: LPost@lsuhsc.edu

Shreveport
LSU Health Sciences Center at Shreveport
Contact: Site Public Contact
Email: LPost@lsuhsc.edu

MN
Bemidji
Sanford Joe Lueken Cancer Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Coon Rapids
Mercy Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Edina
Fairview Southdale Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Fridley
Unity Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Maplewood
Minnesota Oncology Hematology PA-Maplewood
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Saint John's Hospital - Healtheast
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Minneapolis
Abbott-Northwestern Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Health Partners Inc
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Hennepin County Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Robbinsdale
North Memorial Medical Health Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Saint Paul
Regions Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

United Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Shakopee
Saint Francis Regional Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Stillwater
Lakeview Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Willmar
Rice Memorial Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Woodbury
Minnesota Oncology Hematology PA-Woodbury
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

MS
Oxford
Baptist Memorial Hospital and Cancer Center-Oxford
Contact: Site Public Contact
Email: BCCclintrials@bmhcc.org

ND
Bismarck
Sanford Bismarck Medical Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Fargo
Sanford Broadway Medical Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford Roger Maris Cancer Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

NE
Grand Island
CHI Health Saint Francis
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org

NM
Albuquerque
University of New Mexico Cancer Center
Contact: Site Public Contact
Email: LByatt@nmcca.org

Las Cruces
Memorial Medical Center - Las Cruces
Contact: Site Public Contact
Email: Kim.Hoffman@lpnt.net

NV
Henderson
OptumCare Cancer Care at Seven Hills
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas
Ann M Wierman MD LTD
Contact: Site Public Contact
Email: research@sncrf.org

HealthCare Partners Medical Group Oncology/Hematology-San Martin
Contact: Site Public Contact
Email: research@sncrf.org

HealthCare Partners Medical Group Oncology/Hematology-Tenaya
Contact: Site Public Contact
Email: research@sncrf.org

OptumCare Cancer Care at Charleston
Contact: Site Public Contact
Email: research@sncrf.org

OptumCare Cancer Care at Fort Apache
Contact: Site Public Contact
Email: research@sncrf.org

NY
Bronx
Montefiore Medical Center - Moses Campus
Contact: Site Public Contact
Email: eskwak@montefiore.org

Montefiore Medical Center-Einstein Campus
Contact: Site Public Contact
Email: eskwak@montefiore.org

Montefiore Medical Center-Weiler Hospital
Contact: Site Public Contact
Email: eskwak@montefiore.org

OH
Belpre
Strecker Cancer Center-Belpre
Contact: Site Public Contact
Email: sheree@columbusccop.org

Chillicothe
Adena Regional Medical Center
Contact: Site Public Contact
Email: sheree@columbusccop.org

Columbus
Columbus Oncology and Hematology Associates Inc
Contact: Site Public Contact
Email: sheree@columbusccop.org

The Mark H Zangmeister Center
Contact: Site Public Contact
Email: sheree@columbusccop.org

Marietta
Marietta Memorial Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Mount Vernon
Knox Community Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Newark
Licking Memorial Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Portsmouth
Southern Ohio Medical Center
Contact: Site Public Contact
Email: sheree@columbusccop.org

OR
Clackamas
Clackamas Radiation Oncology Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Providence Cancer Institute Clackamas Clinic
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Newberg
Providence Newberg Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Portland
Providence Portland Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Providence Saint Vincent Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

PA
Paoli
Paoli Memorial Hospital
Contact: Site Public Contact
Email: turzoe@mlhs.org

Wynnewood
Lankenau Medical Center
Contact: Site Public Contact
Email: turzoe@mlhs.org

SC
Anderson
AnMed Health Cancer Center
Contact: Site Public Contact
Email: rhonda.ballew@anmedhealth.org

Charleston
Medical University of South Carolina
Contact: Site Public Contact
Email: hcc-clinical-trials@musc.edu

Greer
Gibbs Cancer Center-Pelham
Contact: Site Public Contact
Email: kmertz-rivera@gibbscc.org

Spartanburg
Spartanburg Medical Center
Contact: Site Public Contact
Email: kmertz-rivera@gibbscc.org

SD
Sioux Falls
Sanford Cancer Center Oncology Clinic
Contact: Site Public Contact
Email: OncologyClinicTrialsSF@sanfordhealth.org

Sanford USD Medical Center - Sioux Falls
Contact: Site Public Contact
Email: OncologyClinicalTrialsSF@SanfordHealth.org

TN
Memphis
Baptist Memorial Hospital and Cancer Center-Memphis
Contact: Site Public Contact
Email: BCCclintrials@bmhcc.org

Baptist Memorial Hospital for Women
Contact: Site Public Contact
Email: BCCclintrials@bmhcc.org

Nashville
Meharry Medical College
Contact: Site Public Contact
Email: Nancy.McCullough@NashvilleHA.org

VA
Richmond
Virginia Commonwealth University/Massey Cancer Center
Contact: Site Public Contact
Email: klcampbell@vcu.edu

WI
Burlington
Aurora Cancer Care-Southern Lakes VLCC
Contact: Site Public Contact
Email: ncorp@aurora.org

Fond Du Lac
Aurora Health Center-Fond du Lac
Contact: Site Public Contact
Email: ncorp@aurora.org

Grafton
Aurora Cancer Care-Grafton
Contact: Site Public Contact
Email: ncorp@aurora.org

Green Bay
Aurora BayCare Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org

Kenosha
Aurora Cancer Care-Kenosha South
Contact: Site Public Contact
Email: ncorp@aurora.org

Milwaukee
Aurora Cancer Care-Milwaukee
Contact: Site Public Contact
Email: ncorp@aurora.org

Aurora Saint Luke's Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org

New Richmond
Cancer Center of Western Wisconsin
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Oshkosh
Vince Lombardi Cancer Clinic - Oshkosh
Contact: Site Public Contact
Email: ncorp@aurora.org

Sheboygan
Vince Lombardi Cancer Clinic-Sheboygan
Contact: Site Public Contact
Email: ncorp@aurora.org

Summit
Aurora Medical Center in Summit
Contact: Site Public Contact
Email: ncorp@aurora.org

Two Rivers
Vince Lombardi Cancer Clinic-Two Rivers
Contact: Site Public Contact
Email: ncorp@aurora.org

Wauwatosa
Aurora Cancer Care-Milwaukee West
Contact: Site Public Contact
Email: ncorp@aurora.org

West Allis
Aurora West Allis Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org

WY
Cheyenne
Cheyenne Regional Medical Center-West
Contact: Site Public Contact
Email: ccrp@co-cancerresearch.org

PRIMARY OBJECTIVE:
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.

CORRELATIVES OBJECTIVE:
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.

QUALITY OF LIFE OBJECTIVE:
I. 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 sites are randomized to 1 of 2 arms. Patients are assigned to arms based on participating site.

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, patients are followed up at 3, 6, 12, and 24 months.

Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.


The ECOG-ACRIN Cancer Research Group designed and conducted this trial with funding from the National Cancer Institute through its National Clinical Trials Network.


E1Q11 / EROS (Closed)
ECOG-ACRIN Cancer Research Group