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癌症患者的生殖健康计划 (EROS)

2026年9月14日更新者：ECOG-ACRIN Cancer Research Group

EROS：在肿瘤幸存者中促进生殖健康

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.

研究概览

地位

主动，不招人

条件

恶性肿瘤

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

434

阶段

不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

15年至 55年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

女性

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：支持治疗
分配：随机化
介入模型：并行分配
屏蔽：无（打开标签）

手臂数量

武器和干预

参与者组/臂	干预/治疗
有源比较器：Arm A (no intervention) Patients undergo usual standard practice related to reproductive health.	其他：Standard practice related to reproductive heath Patients undergo usual standard practice related to reproductive health.
实验性的：Arm B (reproductive health program) Patients undergo reproductive health program comprising didactics, reproductive health assessment and navigating algorithm, and network development.	其他：Training modules, algorithm, referral development Patients undergo reproductive health program comprising didactics, reproductive health assessment and navigating algorithm, and network development.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Proportion of Patients With Appropriate Reproductive Health Management 大体时间：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

次要结果测量

结果测量	措施说明	大体时间
Difference in Rating Between Patients and Their Clinicians in Importance of Fertility Maintenance 大体时间：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 大体时间：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 大体时间：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

其他结果措施

结果测量	措施说明	大体时间
Levels of Endocrine Markers of Fertility 大体时间：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) 大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

ECOG-ACRIN Cancer Research Group

合作者

National Cancer Institute (NCI)

调查人员

首席研究员：Ashlesha Patel、Eastern Cooperative Oncology Group

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年9月2日

初级完成 (实际的)

2021年7月31日

研究完成 (估计的)

2026年12月31日

研究注册日期

首次提交

2013年2月19日

首先提交符合 QC 标准的

2013年3月5日

首次发布 (估计的)

2013年3月7日

研究记录更新

最后更新发布 (实际的)

2026年10月6日

上次提交的符合 QC 标准的更新

2026年9月14日

最后验证

2026年9月1日

癌症患者的生殖健康计划 (EROS)

EROS：在肿瘤幸存者中促进生殖健康

研究概览

地位

条件

干预/治疗

详细说明

研究类型

注册 (实际的)

阶段

联系人和位置

学习地点

参与标准

资格标准

适合学习的年龄

接受健康志愿者

有资格学习的性别

描述

学习计划

研究是如何设计的？

设计细节

手臂数量

武器和干预

参与者组/臂

干预/治疗

研究衡量的是什么？

主要结果指标

结果测量

措施说明

大体时间

次要结果测量

结果测量

措施说明

大体时间

其他结果措施

结果测量

措施说明

大体时间

合作者和调查者

赞助

合作者

调查人员

研究记录日期

研究主要日期

学习开始 (实际的)

初级完成 (实际的)

研究完成 (估计的)

研究注册日期

首次提交

首先提交符合 QC 标准的

首次发布 (估计的)

研究记录更新

最后更新发布 (实际的)

上次提交的符合 QC 标准的更新

最后验证

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

IPD 计划说明

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