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Programa de Salud Reproductiva en Pacientes con Cáncer (EROS)

14 de septiembre de 2026 actualizado por: ECOG-ACRIN Cancer Research Group

EROS: Generando Salud Reproductiva Dentro de la Supervivencia Oncológica

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.

Descripción general del estudio

Estado

Activo, no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

434

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

15 años a 55 años (Niño, Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Arm A (no intervention)

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

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

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

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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Proportion of Patients With Appropriate Reproductive Health Management
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Difference in Rating Between Patients and Their Clinicians in Importance of Fertility Maintenance
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Levels of Endocrine Markers of Fertility
Periodo de tiempo: 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)
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

ECOG-ACRIN Cancer Research Group

Colaboradores

National Cancer Institute (NCI)

Investigadores

  • Investigador principal: Ashlesha Patel, Eastern Cooperative Oncology Group

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

2 de septiembre de 2016

Finalización primaria (Actual)

31 de julio de 2021

Finalización del estudio (Estimado)

31 de diciembre de 2026

Fechas de registro del estudio

Enviado por primera vez

19 de febrero de 2013

Primero enviado que cumplió con los criterios de control de calidad

5 de marzo de 2013

Publicado por primera vez (Estimado)

7 de marzo de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

14 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • E1Q11
  • U10CA037403 (Subvención/contrato del NIH de EE. UU.)
  • NCI-2012-02869 (Identificador de registro: CTRP (Clinical Trial Reporting Program))

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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