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Malignant NeoplasmEROSNCT01806129

Reproductive Health Program in Patients With Cancer

A study testing Standard practice related to reproductive heath and Training modules, algorithm, referral development in people with Malignant Neoplasm, run by ECOG-ACRIN Cancer Research Group at 109 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 15 to 55 years, women only
Conditions the study is for
Malignant Neoplasm
What is being tested?
Standard practice related to reproductive heath and Training modules, algorithm, referral development
Could I receive a placebo?
No, everyone receives an active treatment
How many people
434 participants
Where
109 sitesUnited States
Study dates
2 Sep 2016to 31 Dec 2026
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 55 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

109 sites in 1 country.

109 sites in 1 country

United States109 sites

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87102

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

  • MultiCare Auburn Medical Center

    Auburn, Washington, 98001

  • Augusta University Medical Center

    Augusta, Georgia, 30912

  • Rocky Mountain Cancer Centers-Aurora

    Aurora, Colorado, 80012

  • Strecker Cancer Center-Belpre

    Belpre, Ohio, 45714

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Rocky Mountain Cancer Centers-Boulder

    Boulder, Colorado, 80304

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Cheyenne Regional Medical Center-West

    Cheyenne, Wyoming, 82001

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • Providence Cancer Institute Clackamas Clinic

    Clackamas, Oregon, 97015

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

  • John B Amos Cancer Center

    Columbus, Georgia, 31904

  • Columbus Oncology and Hematology Associates Inc

    Columbus, Ohio, 43214

  • The Mark H Zangmeister Center

    Columbus, Ohio, 43219

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Greater Regional Medical Center

    Creston, Iowa, 50801

  • Carle on Vermilion

    Danville, Illinois, 61832

  • Cancer Center of Colorado at Sloan's Lake

    Denver, Colorado, 80204

  • Medical Oncology and Hematology Associates-Laurel

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Aurora Health Center-Fond du Lac

    Fond du Lac, Wisconsin, 54937

  • Unity Hospital

    Fridley, Minnesota, 55432

  • MultiCare Gig Harbor Medical Park

    Gig Harbor, Washington, 98335

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

  • CHI Health Saint Francis

    Grand Island, Nebraska, 68803

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina, 29651

  • OptumCare Cancer Care at Seven Hills

    Henderson, Nevada, 89052

  • Hawaii Cancer Care Inc-POB II

    Honolulu, Hawaii, 96813

  • Queen's Cancer Cenrer - POB I

    Honolulu, Hawaii, 96813

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

  • Queen's Cancer Center - Kuakini

    Honolulu, Hawaii, 96817

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859

  • Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

    Jonesboro, Arkansas, 72401

  • Aurora Cancer Care-Kenosha South

    Kenosha, Wisconsin, 53142

  • Memorial Medical Center - Las Cruces

    Las Cruces, New Mexico, 88011

  • OptumCare Cancer Care at Oakey

    Las Vegas, Nevada, 89102

  • HealthCare Partners Medical Group Oncology/Hematology-San Martin

    Las Vegas, Nevada, 89113

  • Ann M Wierman MD LTD

    Las Vegas, Nevada, 89128

  • HealthCare Partners Medical Group Oncology/Hematology-Tenaya

    Las Vegas, Nevada, 89128

  • OptumCare Cancer Care at Fort Apache

    Las Vegas, Nevada, 89148

  • Saint Joseph Hospital East

    Lexington, Kentucky, 40509

  • Saint Joseph London

    London, Kentucky, 40741

  • Rocky Mountain Cancer Centers-Sky Ridge

    Lone Tree, Colorado, 80124

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

  • Baptist Memorial Hospital and Cancer Center-Memphis

    Memphis, Tennessee, 38120

  • Aurora Cancer Care-Milwaukee

    Milwaukee, Wisconsin, 53209

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Health Partners Inc

    Minneapolis, Minnesota, 55454

  • Ochsner LSU Health Monroe Medical Center

    Monroe, Louisiana, 71202

  • Knox Community Hospital

    Mount Vernon, Ohio, 43050

  • Meharry Medical College

    Nashville, Tennessee, 37208

  • Cancer Center of Western Wisconsin

    New Richmond, Wisconsin, 54017

  • Licking Memorial Hospital

    Newark, Ohio, 43055

  • Providence Newberg Medical Center

    Newberg, Oregon, 97132

  • Vince Lombardi Cancer Clinic - Oshkosh

    Oshkosh, Wisconsin, 54904

  • Baptist Memorial Hospital and Cancer Center-Oxford

    Oxford, Mississippi, 38655

  • Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

  • Southern Ohio Medical Center

    Portsmouth, Ohio, 45662

  • MultiCare Good Samaritan Hospital

    Puyallup, Washington, 98372

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia, 23298

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

  • Vince Lombardi Cancer Clinic-Sheboygan

    Sheboygan, Wisconsin, 53081

  • LSU Health Sciences Center at Shreveport

    Shreveport, Louisiana, 71103

  • Sanford Cancer Center Oncology Clinic

    Sioux Falls, South Dakota, 57104

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

  • Lakeview Hospital

    Stillwater, Minnesota, 55082

  • Aurora Medical Center in Summit

    Summit, Wisconsin, 53066

  • MultiCare Tacoma General Hospital

    Tacoma, Washington, 98405

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New York, 10461

  • Montefiore Medical Center-Weiler Hospital

    The Bronx, New York, 10461

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467

  • Vince Lombardi Cancer Clinic-Two Rivers

    Two Rivers, Wisconsin, 54241

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • The Carle Foundation Hospital

    Urbana, Illinois, 61801

  • Aurora Cancer Care-Milwaukee West

    Wauwatosa, Wisconsin, 53226

  • Aurora West Allis Medical Center

    West Allis, Wisconsin, 53227

  • Mercy Medical Center-West Lakes

    West Des Moines, Iowa, 50266

  • SCL Health Lutheran Medical Center

    Wheat Ridge, Colorado, 80033

  • Rice Memorial Hospital

    Willmar, Minnesota, 56201

  • Minnesota Oncology Hematology PA-Woodbury

    Woodbury, Minnesota, 55125

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096

Other trials in United States

About this study

Official title: EROS: Engendering Reproductive Health Within Oncologic Survivorship

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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:

  1. 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.

Being tested
Standard practice related to reproductive heath, Training modules, algorithm, referral development
Keywords
reproductive health
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard practice related to reproductive heathOther

    Patients undergo usual standard practice related to reproductive health.

  • Training modules, algorithm, referral developmentOther

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

Study groups in NCT01806129
Study groupRoleWhat they receive
Arm A (no intervention)Active comparatorPatients undergo usual standard practice related to reproductive health.
Receives: Other: Standard practice related to reproductive heath
Arm B (reproductive health program)ExperimentalPatients undergo reproductive health program comprising didactics, reproductive health assessment and navigating algorithm, and network development.
Receives: Other: Training modules, algorithm, referral development

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Patients With Appropriate Reproductive Health Management

    Appropriate reproductive health management was determined using the followings: (1) Females that were pregnant or interested in immediate pregnancy (defined as within 1 year of enrollment) were given referral to obstetrician/gynecologist or counseled about pregnancy options (2) Females interested in future childbearing were counseled or given a referral for fertility preservation if requested (3) Females who were not interested in immediate pregnancy were given a referral or counseling to select family planning that was consistent with plans for sexual activity and future childbearing. If a female fell into category 1, 2, or 3, and the appropriate referral occurred within 3 months of enrollment, then appropriate reproductive health management was achieved. For patients with appropriate reproductive health management in place before the baseline visit, they were included in the analysis and counted as having appropriate reproductive health management.

    Measured: At baseline and 3 months

Secondary outcomes (3)

  1. Difference in Rating Between Patients and Their Clinicians in Importance of Fertility Maintenance

    The rating on the importance of fertility maintenance was assessed among patients and the corresponding treating physicians. The rating scale ranges between 1 and 10. Higher scores indicate more importance of fertility maintenance. The difference in rating was calculated by subtracting patient rating from physician's rating.

    Measured: At baseline

  2. The Changes in Reproductive Health Status From Baseline to 3 Months

    Patient's reproductive health choices relating to oncofertility, oncocontraception and pregnancy was assessed at baseline and 3 months. Patient's reproductive health status is categorized into the following categories:

    • Sextually active \& childbearing not completed
    • Sextually active \& childbearing completed
    • Sextually not active \& childbearing not completed
    • Sextually not active \& childbearing completed
    • Sexuality unknown \& childbearing not completed
    • Sexuality unknown \& childbearing completed
    • Pregnant/Pregnancy in 1 year
    • Missing/Unknown

    Measured: Baseline and 3 months

  3. Associations Between Clinical and Demographic Factors and Adequacy of Reproductive Health Care Management

    Appropriate reproductive health management was determined using the followings: (1) Females that were pregnant or interested in immediate pregnancy (defined as within 1 year of enrollment) were given referral to obstetrician/gynecologist or counseled about pregnancy options (2) Females interested in future childbearing were counseled or given a referral for fertility preservation if requested (3) Females who were not interested in immediate pregnancy were given a referral or counseling to select family planning that was consistent with plans for sexual activity and future childbearing. If a female fell into category 1, 2, or 3, and the appropriate referral occurred within 3 months of enrollment, then appropriate reproductive health management was achieved. For patients with appropriate reproductive health management in place before the baseline visit, they were included in the analysis and counted as having appropriate reproductive health management.

    Measured: Baseline and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2013 (estimated)
  2. Study start2 Sep 2016
  3. Primary completion31 Jul 2021
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
434 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01806129
Sponsor's protocol ID
E1Q11
Other IDs
NCI-2012-02869, U10CA037403
Acronym
EROS
Status last verified
Sep 2026
First submitted
19 Feb 2013
Last updated
6 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.

Questions about this trial

What is this clinical trial studying?

A study testing Standard practice related to reproductive heath and Training modules, algorithm, referral development in people with Malignant Neoplasm, run by ECOG-ACRIN Cancer Research Group at 109 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 109 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Patients With Appropriate Reproductive Health Management (time frame: At baseline and 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01806129.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

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