Program reprodukčního zdraví u pacientů s rakovinou (EROS)
EROS: Vytváření reprodukčního zdraví v rámci onkologického přežití
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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Arkansas
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Jonesboro, Arkansas, Spojené státy, 72401
- Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
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Colorado
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Aurora, Colorado, Spojené státy, 80012
- Rocky Mountain Cancer Centers-Aurora
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Boulder, Colorado, Spojené státy, 80304
- Rocky Mountain Cancer Centers-Boulder
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Denver, Colorado, Spojené státy, 80204
- Cancer Center of Colorado at Sloan's Lake
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Lone Tree, Colorado, Spojené státy, 80124
- Rocky Mountain Cancer Centers-Sky Ridge
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Wheat Ridge, Colorado, Spojené státy, 80033
- SCL Health Lutheran Medical Center
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Georgia
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Augusta, Georgia, Spojené státy, 30912
- Augusta University Medical Center
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Columbus, Georgia, Spojené státy, 31904
- John B Amos Cancer Center
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Hawaii
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Honolulu, Hawaii, Spojené státy, 96813
- Queen's Medical Center
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Honolulu, Hawaii, Spojené státy, 96813
- Queen's Cancer Cenrer - POB I
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Honolulu, Hawaii, Spojené státy, 96813
- Straub Clinic and Hospital
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Honolulu, Hawaii, Spojené státy, 96813
- University of Hawaii Cancer Center
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Honolulu, Hawaii, Spojené státy, 96817
- Queen's Cancer Center - Kuakini
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Honolulu, Hawaii, Spojené státy, 96826
- Kapiolani Medical Center for Women and Children
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Honolulu, Hawaii, Spojené státy, 96813
- Hawaii Cancer Care Inc-POB II
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Honolulu, Hawaii, Spojené státy, 96859
- Tripler Army Medical Center
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‘Aiea, Hawaii, Spojené státy, 96701
- Pali Momi Medical Center
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Illinois
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Chicago, Illinois, Spojené státy, 60612
- John H Stroger Jr Hospital of Cook County
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Danville, Illinois, Spojené státy, 61832
- Carle on Vermilion
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Effingham, Illinois, Spojené státy, 62401
- Carle Physician Group-Effingham
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Mattoon, Illinois, Spojené státy, 61938
- Carle Physician Group-Mattoon/Charleston
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Urbana, Illinois, Spojené státy, 61801
- Carle Cancer Center
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Urbana, Illinois, Spojené státy, 61801
- The Carle Foundation Hospital
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Iowa
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Clive, Iowa, Spojené státy, 50325
- Mercy Cancer Center-West Lakes
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Clive, Iowa, Spojené státy, 50325
- Medical Oncology and Hematology Associates-West Des Moines
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Creston, Iowa, Spojené státy, 50801
- Greater Regional Medical Center
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Des Moines, Iowa, Spojené státy, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, Spojené státy, 50314
- Medical Oncology and Hematology Associates-Laurel
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West Des Moines, Iowa, Spojené státy, 50266
- Mercy Medical Center-West Lakes
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Kentucky
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Lexington, Kentucky, Spojené státy, 40509
- Saint Joseph Hospital East
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London, Kentucky, Spojené státy, 40741
- Saint Joseph London
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Louisiana
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Monroe, Louisiana, Spojené státy, 71202
- Ochsner LSU Health Monroe Medical Center
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Shreveport, Louisiana, Spojené státy, 71103
- LSU Health Sciences Center at Shreveport
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Minnesota
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Bemidji, Minnesota, Spojené státy, 56601
- Sanford Joe Lueken Cancer Center
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Coon Rapids, Minnesota, Spojené státy, 55433
- Mercy Hospital
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Edina, Minnesota, Spojené státy, 55435
- Fairview Southdale Hospital
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Fridley, Minnesota, Spojené státy, 55432
- Unity Hospital
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Maplewood, Minnesota, Spojené státy, 55109
- Saint John's Hospital - Healtheast
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Maplewood, Minnesota, Spojené státy, 55109
- Minnesota Oncology Hematology PA-Maplewood
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Minneapolis, Minnesota, Spojené státy, 55415
- Hennepin County Medical Center
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Minneapolis, Minnesota, Spojené státy, 55407
- Abbott-Northwestern Hospital
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Minneapolis, Minnesota, Spojené státy, 55454
- Health Partners Inc
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Robbinsdale, Minnesota, Spojené státy, 55422
- North Memorial Medical Health Center
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Saint Louis Park, Minnesota, Spojené státy, 55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Paul, Minnesota, Spojené státy, 55101
- Regions Hospital
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Saint Paul, Minnesota, Spojené státy, 55102
- United Hospital
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Shakopee, Minnesota, Spojené státy, 55379
- Saint Francis Regional Medical Center
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Stillwater, Minnesota, Spojené státy, 55082
- Lakeview Hospital
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Willmar, Minnesota, Spojené státy, 56201
- Rice Memorial Hospital
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Woodbury, Minnesota, Spojené státy, 55125
- Minnesota Oncology Hematology PA-Woodbury
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Mississippi
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Oxford, Mississippi, Spojené státy, 38655
- Baptist Memorial Hospital and Cancer Center-Oxford
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Nebraska
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Grand Island, Nebraska, Spojené státy, 68803
- CHI Health Saint Francis
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Nevada
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Henderson, Nevada, Spojené státy, 89052
- OptumCare Cancer Care at Seven Hills
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Las Vegas, Nevada, Spojené státy, 89148
- OptumCare Cancer Care at Fort Apache
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Las Vegas, Nevada, Spojené státy, 89113
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
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Las Vegas, Nevada, Spojené státy, 89128
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
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Las Vegas, Nevada, Spojené státy, 89128
- Ann M Wierman MD LTD
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Las Vegas, Nevada, Spojené státy, 89102
- OptumCare Cancer Care at Oakey
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New Mexico
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Albuquerque, New Mexico, Spojené státy, 87102
- University of New Mexico Cancer Center
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Las Cruces, New Mexico, Spojené státy, 88011
- Memorial Medical Center - Las Cruces
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New York
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The Bronx, New York, Spojené státy, 10461
- Montefiore Medical Center-Einstein Campus
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The Bronx, New York, Spojené státy, 10467
- Montefiore Medical Center - Moses Campus
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The Bronx, New York, Spojené státy, 10461
- Montefiore Medical Center-Weiler Hospital
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North Dakota
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Bismarck, North Dakota, Spojené státy, 58501
- Sanford Bismarck Medical Center
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Fargo, North Dakota, Spojené státy, 58122
- Sanford Roger Maris Cancer Center
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Fargo, North Dakota, Spojené státy, 58122
- Sanford Broadway Medical Center
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Ohio
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Belpre, Ohio, Spojené státy, 45714
- Strecker Cancer Center-Belpre
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Chillicothe, Ohio, Spojené státy, 45601
- Adena Regional Medical Center
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Columbus, Ohio, Spojené státy, 43219
- The Mark H Zangmeister Center
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Columbus, Ohio, Spojené státy, 43214
- Columbus Oncology and Hematology Associates Inc
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Marietta, Ohio, Spojené státy, 45750
- Marietta Memorial Hospital
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Mount Vernon, Ohio, Spojené státy, 43050
- Knox Community Hospital
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Newark, Ohio, Spojené státy, 43055
- Licking Memorial Hospital
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Portsmouth, Ohio, Spojené státy, 45662
- Southern Ohio Medical Center
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Oregon
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Clackamas, Oregon, Spojené státy, 97015
- Clackamas Radiation Oncology Center
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Clackamas, Oregon, Spojené státy, 97015
- Providence Cancer Institute Clackamas Clinic
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Newberg, Oregon, Spojené státy, 97132
- Providence Newberg Medical Center
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Portland, Oregon, Spojené státy, 97213
- Providence Portland Medical Center
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Portland, Oregon, Spojené státy, 97225
- Providence Saint Vincent Medical Center
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Pennsylvania
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Paoli, Pennsylvania, Spojené státy, 19301
- Paoli Memorial Hospital
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Wynnewood, Pennsylvania, Spojené státy, 19096
- Lankenau Medical Center
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South Carolina
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Anderson, South Carolina, Spojené státy, 29621
- AnMed Health Cancer Center
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Charleston, South Carolina, Spojené státy, 29425
- Medical University of South Carolina
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Greer, South Carolina, Spojené státy, 29651
- Gibbs Cancer Center-Pelham
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Spartanburg, South Carolina, Spojené státy, 29303
- Spartanburg Medical Center
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South Dakota
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Sioux Falls, South Dakota, Spojené státy, 57117-5134
- Sanford USD Medical Center - Sioux Falls
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Sioux Falls, South Dakota, Spojené státy, 57104
- Sanford Cancer Center Oncology Clinic
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Tennessee
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Memphis, Tennessee, Spojené státy, 38120
- Baptist Memorial Hospital and Cancer Center-Memphis
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Nashville, Tennessee, Spojené státy, 37208
- Meharry Medical College
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Virginia
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Richmond, Virginia, Spojené státy, 23298
- Virginia Commonwealth University/Massey Cancer Center
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Washington
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Auburn, Washington, Spojené státy, 98001
- MultiCare Auburn Medical Center
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Gig Harbor, Washington, Spojené státy, 98335
- MultiCare Gig Harbor Medical Park
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Puyallup, Washington, Spojené státy, 98372
- MultiCare Good Samaritan Hospital
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Tacoma, Washington, Spojené státy, 98405
- MultiCare Tacoma General Hospital
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Wisconsin
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Burlington, Wisconsin, Spojené státy, 53105
- Aurora Cancer Care-Southern Lakes VLCC
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Fond du Lac, Wisconsin, Spojené státy, 54937
- Aurora Health Center-Fond du Lac
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Grafton, Wisconsin, Spojené státy, 53024
- Aurora Cancer Care-Grafton
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Green Bay, Wisconsin, Spojené státy, 54311
- Aurora BayCare Medical Center
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Kenosha, Wisconsin, Spojené státy, 53142
- Aurora Cancer Care-Kenosha South
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Milwaukee, Wisconsin, Spojené státy, 53209
- Aurora Cancer Care-Milwaukee
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Milwaukee, Wisconsin, Spojené státy, 53215
- Aurora Saint Luke's Medical Center
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New Richmond, Wisconsin, Spojené státy, 54017
- Cancer Center of Western Wisconsin
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Oshkosh, Wisconsin, Spojené státy, 54904
- Vince Lombardi Cancer Clinic - Oshkosh
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Sheboygan, Wisconsin, Spojené státy, 53081
- Vince Lombardi Cancer Clinic-Sheboygan
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Summit, Wisconsin, Spojené státy, 53066
- Aurora Medical Center in Summit
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Two Rivers, Wisconsin, Spojené státy, 54241
- Vince Lombardi Cancer Clinic-Two Rivers
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Wauwatosa, Wisconsin, Spojené státy, 53226
- Aurora Cancer Care-Milwaukee West
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West Allis, Wisconsin, Spojené státy, 53227
- Aurora West Allis Medical Center
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Wyoming
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Cheyenne, Wyoming, Spojené státy, 82001
- Cheyenne Regional Medical Center-West
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
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Female patients presenting with initial diagnosis of any type of cancer, including patients with ductal carcinoma in situ (DCIS)
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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
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Pregnant women are eligible to participate in this study
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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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: Arm A (no intervention)
Patients undergo usual standard practice related to reproductive health. |
Patients undergo usual standard practice related to reproductive health. |
|
Experimentální: Arm B (reproductive health program)
Patients undergo reproductive health program comprising didactics, reproductive health assessment and navigating algorithm, and network development. |
Patients undergo reproductive health program comprising didactics, reproductive health assessment and navigating algorithm, and network development. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Proportion of Patients With Appropriate Reproductive Health Management
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Difference in Rating Between Patients and Their Clinicians in Importance of Fertility Maintenance
Časové okno: 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
Časové okno: 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:
|
Baseline and 3 months
|
|
Associations Between Clinical and Demographic Factors and Adequacy of Reproductive Health Care Management
Časové okno: 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
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Levels of Endocrine Markers of Fertility
Časové okno: 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)
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Ashlesha Patel, Eastern Cooperative Oncology Group
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhadovaný)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- E1Q11
- U10CA037403 (Grant/smlouva NIH USA)
- NCI-2012-02869 (Identifikátor registru: CTRP (Clinical Trial Reporting Program))
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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