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Programa de Saúde Reprodutiva em Pacientes com Câncer (EROS)

14 de setembro de 2026 atualizado por: ECOG-ACRIN Cancer Research Group

EROS: Gerando Saúde Reprodutiva na Sobrevivência 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.

Visão geral do estudo

Status

Ativo, não recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Real)

434

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • 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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

15 anos a 55 anos (Filho, Adulto)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Fêmea

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Arm A (no intervention)

Patients undergo usual standard practice related to reproductive health.
Outro: 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.
Outro: Training modules, algorithm, referral development

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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Proportion of Patients With Appropriate Reproductive Health Management
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Difference in Rating Between Patients and Their Clinicians in Importance of Fertility Maintenance
Prazo: 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
Prazo: 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
Prazo: 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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Levels of Endocrine Markers of Fertility
Prazo: 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)
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

ECOG-ACRIN Cancer Research Group

Colaboradores

National Cancer Institute (NCI)

Investigadores

  • Investigador principal: Ashlesha Patel, Eastern Cooperative Oncology Group

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

2 de setembro de 2016

Conclusão Primária (Real)

31 de julho de 2021

Conclusão do estudo (Estimado)

31 de dezembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

19 de fevereiro de 2013

Enviado pela primeira vez que atendeu aos critérios de CQ

5 de março de 2013

Primeira postagem (Estimado)

7 de março de 2013

Atualizações de registro de estudo

Última Atualização Postada (Real)

6 de outubro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

14 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • E1Q11
  • U10CA037403 (Concessão/Contrato do NIH dos EUA)
  • NCI-2012-02869 (Identificador de registro: CTRP (Clinical Trial Reporting Program))

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

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

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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