Program för reproduktiv hälsa hos patienter med cancer (EROS)
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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Arkansas
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Jonesboro, Arkansas, Förenta staterna, 72401
- Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
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Colorado
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Aurora, Colorado, Förenta staterna, 80012
- Rocky Mountain Cancer Centers-Aurora
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Boulder, Colorado, Förenta staterna, 80304
- Rocky Mountain Cancer Centers-Boulder
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Denver, Colorado, Förenta staterna, 80204
- Cancer Center of Colorado at Sloan's Lake
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Lone Tree, Colorado, Förenta staterna, 80124
- Rocky Mountain Cancer Centers-Sky Ridge
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Wheat Ridge, Colorado, Förenta staterna, 80033
- SCL Health Lutheran Medical Center
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Georgia
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Augusta, Georgia, Förenta staterna, 30912
- Augusta University Medical Center
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Columbus, Georgia, Förenta staterna, 31904
- John B Amos Cancer Center
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Hawaii
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Honolulu, Hawaii, Förenta staterna, 96813
- Queen's Medical Center
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Honolulu, Hawaii, Förenta staterna, 96813
- Queen's Cancer Cenrer - POB I
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Honolulu, Hawaii, Förenta staterna, 96813
- Straub Clinic and Hospital
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Honolulu, Hawaii, Förenta staterna, 96813
- University of Hawaii Cancer Center
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Honolulu, Hawaii, Förenta staterna, 96817
- Queen's Cancer Center - Kuakini
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Honolulu, Hawaii, Förenta staterna, 96826
- Kapiolani Medical Center for Women and Children
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Honolulu, Hawaii, Förenta staterna, 96813
- Hawaii Cancer Care Inc-POB II
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Honolulu, Hawaii, Förenta staterna, 96859
- Tripler Army Medical Center
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‘Aiea, Hawaii, Förenta staterna, 96701
- Pali Momi Medical Center
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Illinois
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Chicago, Illinois, Förenta staterna, 60612
- John H Stroger Jr Hospital of Cook County
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Danville, Illinois, Förenta staterna, 61832
- Carle on Vermilion
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Effingham, Illinois, Förenta staterna, 62401
- Carle Physician Group-Effingham
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Mattoon, Illinois, Förenta staterna, 61938
- Carle Physician Group-Mattoon/Charleston
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Urbana, Illinois, Förenta staterna, 61801
- Carle Cancer Center
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Urbana, Illinois, Förenta staterna, 61801
- The Carle Foundation Hospital
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Iowa
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Clive, Iowa, Förenta staterna, 50325
- Mercy Cancer Center-West Lakes
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Clive, Iowa, Förenta staterna, 50325
- Medical Oncology and Hematology Associates-West Des Moines
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Creston, Iowa, Förenta staterna, 50801
- Greater Regional Medical Center
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Des Moines, Iowa, Förenta staterna, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, Förenta staterna, 50314
- Medical Oncology and Hematology Associates-Laurel
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West Des Moines, Iowa, Förenta staterna, 50266
- Mercy Medical Center-West Lakes
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Kentucky
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Lexington, Kentucky, Förenta staterna, 40509
- Saint Joseph Hospital East
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London, Kentucky, Förenta staterna, 40741
- Saint Joseph London
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Louisiana
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Monroe, Louisiana, Förenta staterna, 71202
- Ochsner LSU Health Monroe Medical Center
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Shreveport, Louisiana, Förenta staterna, 71103
- LSU Health Sciences Center at Shreveport
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Minnesota
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Bemidji, Minnesota, Förenta staterna, 56601
- Sanford Joe Lueken Cancer Center
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Coon Rapids, Minnesota, Förenta staterna, 55433
- Mercy Hospital
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Edina, Minnesota, Förenta staterna, 55435
- Fairview Southdale Hospital
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Fridley, Minnesota, Förenta staterna, 55432
- Unity Hospital
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Maplewood, Minnesota, Förenta staterna, 55109
- Saint John's Hospital - Healtheast
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Maplewood, Minnesota, Förenta staterna, 55109
- Minnesota Oncology Hematology PA-Maplewood
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Minneapolis, Minnesota, Förenta staterna, 55415
- Hennepin County Medical Center
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Minneapolis, Minnesota, Förenta staterna, 55407
- Abbott-Northwestern Hospital
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Minneapolis, Minnesota, Förenta staterna, 55454
- Health Partners Inc
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Robbinsdale, Minnesota, Förenta staterna, 55422
- North Memorial Medical Health Center
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Saint Louis Park, Minnesota, Förenta staterna, 55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Paul, Minnesota, Förenta staterna, 55101
- Regions Hospital
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Saint Paul, Minnesota, Förenta staterna, 55102
- United Hospital
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Shakopee, Minnesota, Förenta staterna, 55379
- Saint Francis Regional Medical Center
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Stillwater, Minnesota, Förenta staterna, 55082
- Lakeview Hospital
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Willmar, Minnesota, Förenta staterna, 56201
- Rice Memorial Hospital
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Woodbury, Minnesota, Förenta staterna, 55125
- Minnesota Oncology Hematology PA-Woodbury
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Mississippi
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Oxford, Mississippi, Förenta staterna, 38655
- Baptist Memorial Hospital and Cancer Center-Oxford
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Nebraska
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Grand Island, Nebraska, Förenta staterna, 68803
- CHI Health Saint Francis
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Nevada
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Henderson, Nevada, Förenta staterna, 89052
- OptumCare Cancer Care at Seven Hills
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Las Vegas, Nevada, Förenta staterna, 89148
- OptumCare Cancer Care at Fort Apache
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Las Vegas, Nevada, Förenta staterna, 89113
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
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Las Vegas, Nevada, Förenta staterna, 89128
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
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Las Vegas, Nevada, Förenta staterna, 89128
- Ann M Wierman MD LTD
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Las Vegas, Nevada, Förenta staterna, 89102
- OptumCare Cancer Care at Oakey
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New Mexico
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Albuquerque, New Mexico, Förenta staterna, 87102
- University of New Mexico Cancer Center
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Las Cruces, New Mexico, Förenta staterna, 88011
- Memorial Medical Center - Las Cruces
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New York
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The Bronx, New York, Förenta staterna, 10461
- Montefiore Medical Center-Einstein Campus
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The Bronx, New York, Förenta staterna, 10467
- Montefiore Medical Center - Moses Campus
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The Bronx, New York, Förenta staterna, 10461
- Montefiore Medical Center-Weiler Hospital
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North Dakota
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Bismarck, North Dakota, Förenta staterna, 58501
- Sanford Bismarck Medical Center
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Fargo, North Dakota, Förenta staterna, 58122
- Sanford Roger Maris Cancer Center
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Fargo, North Dakota, Förenta staterna, 58122
- Sanford Broadway Medical Center
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Ohio
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Belpre, Ohio, Förenta staterna, 45714
- Strecker Cancer Center-Belpre
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Chillicothe, Ohio, Förenta staterna, 45601
- Adena Regional Medical Center
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Columbus, Ohio, Förenta staterna, 43219
- The Mark H Zangmeister Center
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Columbus, Ohio, Förenta staterna, 43214
- Columbus Oncology and Hematology Associates Inc
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Marietta, Ohio, Förenta staterna, 45750
- Marietta Memorial Hospital
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Mount Vernon, Ohio, Förenta staterna, 43050
- Knox Community Hospital
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Newark, Ohio, Förenta staterna, 43055
- Licking Memorial Hospital
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Portsmouth, Ohio, Förenta staterna, 45662
- Southern Ohio Medical Center
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Oregon
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Clackamas, Oregon, Förenta staterna, 97015
- Clackamas Radiation Oncology Center
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Clackamas, Oregon, Förenta staterna, 97015
- Providence Cancer Institute Clackamas Clinic
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Newberg, Oregon, Förenta staterna, 97132
- Providence Newberg Medical Center
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Portland, Oregon, Förenta staterna, 97213
- Providence Portland Medical Center
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Portland, Oregon, Förenta staterna, 97225
- Providence Saint Vincent Medical Center
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Pennsylvania
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Paoli, Pennsylvania, Förenta staterna, 19301
- Paoli Memorial Hospital
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Wynnewood, Pennsylvania, Förenta staterna, 19096
- Lankenau Medical Center
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South Carolina
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Anderson, South Carolina, Förenta staterna, 29621
- AnMed Health Cancer Center
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Charleston, South Carolina, Förenta staterna, 29425
- Medical University of South Carolina
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Greer, South Carolina, Förenta staterna, 29651
- Gibbs Cancer Center-Pelham
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Spartanburg, South Carolina, Förenta staterna, 29303
- Spartanburg Medical Center
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South Dakota
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Sioux Falls, South Dakota, Förenta staterna, 57117-5134
- Sanford USD Medical Center - Sioux Falls
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Sioux Falls, South Dakota, Förenta staterna, 57104
- Sanford Cancer Center Oncology Clinic
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Tennessee
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Memphis, Tennessee, Förenta staterna, 38120
- Baptist Memorial Hospital and Cancer Center-Memphis
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Nashville, Tennessee, Förenta staterna, 37208
- Meharry Medical College
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Virginia
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Richmond, Virginia, Förenta staterna, 23298
- Virginia Commonwealth University/Massey Cancer Center
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Washington
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Auburn, Washington, Förenta staterna, 98001
- MultiCare Auburn Medical Center
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Gig Harbor, Washington, Förenta staterna, 98335
- MultiCare Gig Harbor Medical Park
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Puyallup, Washington, Förenta staterna, 98372
- MultiCare Good Samaritan Hospital
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Tacoma, Washington, Förenta staterna, 98405
- MultiCare Tacoma General Hospital
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Wisconsin
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Burlington, Wisconsin, Förenta staterna, 53105
- Aurora Cancer Care-Southern Lakes VLCC
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Fond du Lac, Wisconsin, Förenta staterna, 54937
- Aurora Health Center-Fond du Lac
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Grafton, Wisconsin, Förenta staterna, 53024
- Aurora Cancer Care-Grafton
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Green Bay, Wisconsin, Förenta staterna, 54311
- Aurora BayCare Medical Center
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Kenosha, Wisconsin, Förenta staterna, 53142
- Aurora Cancer Care-Kenosha South
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Milwaukee, Wisconsin, Förenta staterna, 53209
- Aurora Cancer Care-Milwaukee
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Milwaukee, Wisconsin, Förenta staterna, 53215
- Aurora Saint Luke's Medical Center
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New Richmond, Wisconsin, Förenta staterna, 54017
- Cancer Center of Western Wisconsin
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Oshkosh, Wisconsin, Förenta staterna, 54904
- Vince Lombardi Cancer Clinic - Oshkosh
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Sheboygan, Wisconsin, Förenta staterna, 53081
- Vince Lombardi Cancer Clinic-Sheboygan
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Summit, Wisconsin, Förenta staterna, 53066
- Aurora Medical Center in Summit
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Two Rivers, Wisconsin, Förenta staterna, 54241
- Vince Lombardi Cancer Clinic-Two Rivers
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Wauwatosa, Wisconsin, Förenta staterna, 53226
- Aurora Cancer Care-Milwaukee West
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West Allis, Wisconsin, Förenta staterna, 53227
- Aurora West Allis Medical Center
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Wyoming
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Cheyenne, Wyoming, Förenta staterna, 82001
- Cheyenne Regional Medical Center-West
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Arm A (no intervention)
Patients undergo usual standard practice related to reproductive health. |
Patients undergo usual standard practice related to reproductive health. |
|
Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Proportion of Patients With Appropriate Reproductive Health Management
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Difference in Rating Between Patients and Their Clinicians in Importance of Fertility Maintenance
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Levels of Endocrine Markers of Fertility
Tidsram: 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)
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Ashlesha Patel, Eastern Cooperative Oncology Group
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Beräknad)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- E1Q11
- U10CA037403 (U.S.S. NIH-anslag/kontrakt)
- NCI-2012-02869 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.
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