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Programma voor reproductieve gezondheid bij patiënten met kanker (EROS)

14 september 2026 bijgewerkt door: ECOG-ACRIN Cancer Research Group

EROS: voortbrengen van reproductieve gezondheid binnen oncologische overleving

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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

434

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Arkansas
      • Jonesboro, Arkansas, Verenigde Staten, 72401
        • Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
    • Colorado
      • Aurora, Colorado, Verenigde Staten, 80012
        • Rocky Mountain Cancer Centers-Aurora
      • Boulder, Colorado, Verenigde Staten, 80304
        • Rocky Mountain Cancer Centers-Boulder
      • Denver, Colorado, Verenigde Staten, 80204
        • Cancer Center of Colorado at Sloan's Lake
      • Lone Tree, Colorado, Verenigde Staten, 80124
        • Rocky Mountain Cancer Centers-Sky Ridge
      • Wheat Ridge, Colorado, Verenigde Staten, 80033
        • SCL Health Lutheran Medical Center
    • Georgia
      • Augusta, Georgia, Verenigde Staten, 30912
        • Augusta University Medical Center
      • Columbus, Georgia, Verenigde Staten, 31904
        • John B Amos Cancer Center
    • Hawaii
      • Honolulu, Hawaii, Verenigde Staten, 96813
        • Queen's Medical Center
      • Honolulu, Hawaii, Verenigde Staten, 96813
        • Queen's Cancer Cenrer - POB I
      • Honolulu, Hawaii, Verenigde Staten, 96813
        • Straub Clinic and Hospital
      • Honolulu, Hawaii, Verenigde Staten, 96813
        • University of Hawaii Cancer Center
      • Honolulu, Hawaii, Verenigde Staten, 96817
        • Queen's Cancer Center - Kuakini
      • Honolulu, Hawaii, Verenigde Staten, 96826
        • Kapiolani Medical Center for Women and Children
      • Honolulu, Hawaii, Verenigde Staten, 96813
        • Hawaii Cancer Care Inc-POB II
      • Honolulu, Hawaii, Verenigde Staten, 96859
        • Tripler Army Medical Center
      • ‘Aiea, Hawaii, Verenigde Staten, 96701
        • Pali Momi Medical Center
    • Illinois
      • Chicago, Illinois, Verenigde Staten, 60612
        • John H Stroger Jr Hospital of Cook County
      • Danville, Illinois, Verenigde Staten, 61832
        • Carle on Vermilion
      • Effingham, Illinois, Verenigde Staten, 62401
        • Carle Physician Group-Effingham
      • Mattoon, Illinois, Verenigde Staten, 61938
        • Carle Physician Group-Mattoon/Charleston
      • Urbana, Illinois, Verenigde Staten, 61801
        • Carle Cancer Center
      • Urbana, Illinois, Verenigde Staten, 61801
        • The Carle Foundation Hospital
    • Iowa
      • Clive, Iowa, Verenigde Staten, 50325
        • Mercy Cancer Center-West Lakes
      • Clive, Iowa, Verenigde Staten, 50325
        • Medical Oncology and Hematology Associates-West Des Moines
      • Creston, Iowa, Verenigde Staten, 50801
        • Greater Regional Medical Center
      • Des Moines, Iowa, Verenigde Staten, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, Verenigde Staten, 50314
        • Medical Oncology and Hematology Associates-Laurel
      • West Des Moines, Iowa, Verenigde Staten, 50266
        • Mercy Medical Center-West Lakes
    • Kentucky
      • Lexington, Kentucky, Verenigde Staten, 40509
        • Saint Joseph Hospital East
      • London, Kentucky, Verenigde Staten, 40741
        • Saint Joseph London
    • Louisiana
      • Monroe, Louisiana, Verenigde Staten, 71202
        • Ochsner LSU Health Monroe Medical Center
      • Shreveport, Louisiana, Verenigde Staten, 71103
        • LSU Health Sciences Center at Shreveport
    • Minnesota
      • Bemidji, Minnesota, Verenigde Staten, 56601
        • Sanford Joe Lueken Cancer Center
      • Coon Rapids, Minnesota, Verenigde Staten, 55433
        • Mercy Hospital
      • Edina, Minnesota, Verenigde Staten, 55435
        • Fairview Southdale Hospital
      • Fridley, Minnesota, Verenigde Staten, 55432
        • Unity Hospital
      • Maplewood, Minnesota, Verenigde Staten, 55109
        • Saint John's Hospital - Healtheast
      • Maplewood, Minnesota, Verenigde Staten, 55109
        • Minnesota Oncology Hematology PA-Maplewood
      • Minneapolis, Minnesota, Verenigde Staten, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, Verenigde Staten, 55407
        • Abbott-Northwestern Hospital
      • Minneapolis, Minnesota, Verenigde Staten, 55454
        • Health Partners Inc
      • Robbinsdale, Minnesota, Verenigde Staten, 55422
        • North Memorial Medical Health Center
      • Saint Louis Park, Minnesota, Verenigde Staten, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Paul, Minnesota, Verenigde Staten, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, Verenigde Staten, 55102
        • United Hospital
      • Shakopee, Minnesota, Verenigde Staten, 55379
        • Saint Francis Regional Medical Center
      • Stillwater, Minnesota, Verenigde Staten, 55082
        • Lakeview Hospital
      • Willmar, Minnesota, Verenigde Staten, 56201
        • Rice Memorial Hospital
      • Woodbury, Minnesota, Verenigde Staten, 55125
        • Minnesota Oncology Hematology PA-Woodbury
    • Mississippi
      • Oxford, Mississippi, Verenigde Staten, 38655
        • Baptist Memorial Hospital and Cancer Center-Oxford
    • Nebraska
      • Grand Island, Nebraska, Verenigde Staten, 68803
        • CHI Health Saint Francis
    • Nevada
      • Henderson, Nevada, Verenigde Staten, 89052
        • OptumCare Cancer Care at Seven Hills
      • Las Vegas, Nevada, Verenigde Staten, 89148
        • OptumCare Cancer Care at Fort Apache
      • Las Vegas, Nevada, Verenigde Staten, 89113
        • HealthCare Partners Medical Group Oncology/Hematology-San Martin
      • Las Vegas, Nevada, Verenigde Staten, 89128
        • HealthCare Partners Medical Group Oncology/Hematology-Tenaya
      • Las Vegas, Nevada, Verenigde Staten, 89128
        • Ann M Wierman MD LTD
      • Las Vegas, Nevada, Verenigde Staten, 89102
        • OptumCare Cancer Care at Oakey
    • New Mexico
      • Albuquerque, New Mexico, Verenigde Staten, 87102
        • University of New Mexico Cancer Center
      • Las Cruces, New Mexico, Verenigde Staten, 88011
        • Memorial Medical Center - Las Cruces
    • New York
      • The Bronx, New York, Verenigde Staten, 10461
        • Montefiore Medical Center-Einstein Campus
      • The Bronx, New York, Verenigde Staten, 10467
        • Montefiore Medical Center - Moses Campus
      • The Bronx, New York, Verenigde Staten, 10461
        • Montefiore Medical Center-Weiler Hospital
    • North Dakota
      • Bismarck, North Dakota, Verenigde Staten, 58501
        • Sanford Bismarck Medical Center
      • Fargo, North Dakota, Verenigde Staten, 58122
        • Sanford Roger Maris Cancer Center
      • Fargo, North Dakota, Verenigde Staten, 58122
        • Sanford Broadway Medical Center
    • Ohio
      • Belpre, Ohio, Verenigde Staten, 45714
        • Strecker Cancer Center-Belpre
      • Chillicothe, Ohio, Verenigde Staten, 45601
        • Adena Regional Medical Center
      • Columbus, Ohio, Verenigde Staten, 43219
        • The Mark H Zangmeister Center
      • Columbus, Ohio, Verenigde Staten, 43214
        • Columbus Oncology and Hematology Associates Inc
      • Marietta, Ohio, Verenigde Staten, 45750
        • Marietta Memorial Hospital
      • Mount Vernon, Ohio, Verenigde Staten, 43050
        • Knox Community Hospital
      • Newark, Ohio, Verenigde Staten, 43055
        • Licking Memorial Hospital
      • Portsmouth, Ohio, Verenigde Staten, 45662
        • Southern Ohio Medical Center
    • Oregon
      • Clackamas, Oregon, Verenigde Staten, 97015
        • Clackamas Radiation Oncology Center
      • Clackamas, Oregon, Verenigde Staten, 97015
        • Providence Cancer Institute Clackamas Clinic
      • Newberg, Oregon, Verenigde Staten, 97132
        • Providence Newberg Medical Center
      • Portland, Oregon, Verenigde Staten, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, Verenigde Staten, 97225
        • Providence Saint Vincent Medical Center
    • Pennsylvania
      • Paoli, Pennsylvania, Verenigde Staten, 19301
        • Paoli Memorial Hospital
      • Wynnewood, Pennsylvania, Verenigde Staten, 19096
        • Lankenau Medical Center
    • South Carolina
      • Anderson, South Carolina, Verenigde Staten, 29621
        • AnMed Health Cancer Center
      • Charleston, South Carolina, Verenigde Staten, 29425
        • Medical University of South Carolina
      • Greer, South Carolina, Verenigde Staten, 29651
        • Gibbs Cancer Center-Pelham
      • Spartanburg, South Carolina, Verenigde Staten, 29303
        • Spartanburg Medical Center
    • South Dakota
      • Sioux Falls, South Dakota, Verenigde Staten, 57117-5134
        • Sanford USD Medical Center - Sioux Falls
      • Sioux Falls, South Dakota, Verenigde Staten, 57104
        • Sanford Cancer Center Oncology Clinic
    • Tennessee
      • Memphis, Tennessee, Verenigde Staten, 38120
        • Baptist Memorial Hospital and Cancer Center-Memphis
      • Nashville, Tennessee, Verenigde Staten, 37208
        • Meharry Medical College
    • Virginia
      • Richmond, Virginia, Verenigde Staten, 23298
        • Virginia Commonwealth University/Massey Cancer Center
    • Washington
      • Auburn, Washington, Verenigde Staten, 98001
        • MultiCare Auburn Medical Center
      • Gig Harbor, Washington, Verenigde Staten, 98335
        • MultiCare Gig Harbor Medical Park
      • Puyallup, Washington, Verenigde Staten, 98372
        • MultiCare Good Samaritan Hospital
      • Tacoma, Washington, Verenigde Staten, 98405
        • MultiCare Tacoma General Hospital
    • Wisconsin
      • Burlington, Wisconsin, Verenigde Staten, 53105
        • Aurora Cancer Care-Southern Lakes VLCC
      • Fond du Lac, Wisconsin, Verenigde Staten, 54937
        • Aurora Health Center-Fond du Lac
      • Grafton, Wisconsin, Verenigde Staten, 53024
        • Aurora Cancer Care-Grafton
      • Green Bay, Wisconsin, Verenigde Staten, 54311
        • Aurora BayCare Medical Center
      • Kenosha, Wisconsin, Verenigde Staten, 53142
        • Aurora Cancer Care-Kenosha South
      • Milwaukee, Wisconsin, Verenigde Staten, 53209
        • Aurora Cancer Care-Milwaukee
      • Milwaukee, Wisconsin, Verenigde Staten, 53215
        • Aurora Saint Luke's Medical Center
      • New Richmond, Wisconsin, Verenigde Staten, 54017
        • Cancer Center of Western Wisconsin
      • Oshkosh, Wisconsin, Verenigde Staten, 54904
        • Vince Lombardi Cancer Clinic - Oshkosh
      • Sheboygan, Wisconsin, Verenigde Staten, 53081
        • Vince Lombardi Cancer Clinic-Sheboygan
      • Summit, Wisconsin, Verenigde Staten, 53066
        • Aurora Medical Center in Summit
      • Two Rivers, Wisconsin, Verenigde Staten, 54241
        • Vince Lombardi Cancer Clinic-Two Rivers
      • Wauwatosa, Wisconsin, Verenigde Staten, 53226
        • Aurora Cancer Care-Milwaukee West
      • West Allis, Wisconsin, Verenigde Staten, 53227
        • Aurora West Allis Medical Center
    • Wyoming
      • Cheyenne, Wyoming, Verenigde Staten, 82001
        • Cheyenne Regional Medical Center-West

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

15 jaar tot 55 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Arm A (no intervention)

Patients undergo usual standard practice related to reproductive health.
Ander: Standard practice related to reproductive heath

Patients undergo usual standard practice related to reproductive health.
Experimenteel: Arm B (reproductive health program)

Patients undergo reproductive health program comprising didactics, reproductive health assessment and navigating algorithm, and network development.
Ander: Training modules, algorithm, referral development

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of Patients With Appropriate Reproductive Health Management
Tijdsspanne: At baseline and 3 months

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.
At baseline and 3 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Difference in Rating Between Patients and Their Clinicians in Importance of Fertility Maintenance
Tijdsspanne: At baseline

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.
At baseline
The Changes in Reproductive Health Status From Baseline to 3 Months
Tijdsspanne: Baseline and 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
Baseline and 3 months
Associations Between Clinical and Demographic Factors and Adequacy of Reproductive Health Care Management
Tijdsspanne: Baseline and 3 months

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.
Baseline and 3 months

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Levels of Endocrine Markers of Fertility
Tijdsspanne: Baseline and 3, 6, 12, 24 months

Reproductive health-related biomarkers, including follicle-stimulating hormone (FSH), anti-müllerian hormone (AMH), thyroid stimulating hormone (TSH) and Thyroid peroxidase (TPO), were evaluated through blood samples collected at baseline and 3, 6, 12, 24 months.
Baseline and 3, 6, 12, 24 months
Sexual Function Score by Patient-Reported Outcomes Measurement Information System (PROMIS)
Tijdsspanne: Baseline and 3, 6, 12, 24 months

Sexual function was evaluated using PROMIS sexual function survey brief profile V1.0. All subdomain scores (except for the orgasm subdomain) are expressed as T-scores with a mean of 50 and a standard deviation of 10. A raw summed score is created for each domain. For Global Satisfaction with Sex Life, the raw summed score can range from 2 (endorsed "Not at all" to both items) to 10 (endorsed "Very" or "Very much" to both items). Higher scores indicate more satisfaction/interest/lubrication/discomfort/ability with sex life. Lower scores indicate less satisfaction/interest/lubrication/discomfort/ability with sex life.
Baseline and 3, 6, 12, 24 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

ECOG-ACRIN Cancer Research Group

Medewerkers

National Cancer Institute (NCI)

Onderzoekers

  • Hoofdonderzoeker: Ashlesha Patel, Eastern Cooperative Oncology Group

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

2 september 2016

Primaire voltooiing (Werkelijk)

31 juli 2021

Studie voltooiing (Geschat)

31 december 2026

Studieregistratiedata

Eerst ingediend

19 februari 2013

Eerst ingediend dat voldeed aan de QC-criteria

5 maart 2013

Eerst geplaatst (Geschat)

7 maart 2013

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

14 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • E1Q11
  • U10CA037403 (Subsidie/contract van de Amerikaanse NIH)
  • NCI-2012-02869 (Register-ID: CTRP (Clinical Trial Reporting Program))

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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