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Reproduktiv helseprogram hos pasienter med kreft (EROS)

14. september 2026 oppdatert av: ECOG-ACRIN Cancer Research Group

EROS: Endering 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.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Faktiske)

434

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

15 år til 55 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Arm A (no intervention)

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

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

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

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of Patients With Appropriate Reproductive Health Management
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Difference in Rating Between Patients and Their Clinicians in Importance of Fertility Maintenance
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Levels of Endocrine Markers of Fertility
Tidsramme: 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)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

ECOG-ACRIN Cancer Research Group

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

  • Hovedetterforsker: Ashlesha Patel, Eastern Cooperative Oncology Group

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

2. september 2016

Primær fullføring (Faktiske)

31. juli 2021

Studiet fullført (Antatt)

31. desember 2026

Datoer for studieregistrering

Først innsendt

19. februar 2013

Først innsendt som oppfylte QC-kriteriene

5. mars 2013

Først lagt ut (Antatt)

7. mars 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • E1Q11
  • U10CA037403 (U.S. NIH-stipend/kontrakt)
  • NCI-2012-02869 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere