Programme de santé reproductive chez les patients atteints de cancer (EROS)
EROS : Engendering Health Reproductive Within Oncological 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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Arkansas
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Jonesboro, Arkansas, États-Unis, 72401
- Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
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Colorado
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Aurora, Colorado, États-Unis, 80012
- Rocky Mountain Cancer Centers-Aurora
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Boulder, Colorado, États-Unis, 80304
- Rocky Mountain Cancer Centers-Boulder
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Denver, Colorado, États-Unis, 80204
- Cancer Center of Colorado at Sloan's Lake
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Lone Tree, Colorado, États-Unis, 80124
- Rocky Mountain Cancer Centers-Sky Ridge
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Wheat Ridge, Colorado, États-Unis, 80033
- SCL Health Lutheran Medical Center
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Georgia
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Augusta, Georgia, États-Unis, 30912
- Augusta University Medical Center
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Columbus, Georgia, États-Unis, 31904
- John B Amos Cancer Center
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Hawaii
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Honolulu, Hawaii, États-Unis, 96813
- Queen's Medical Center
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Honolulu, Hawaii, États-Unis, 96813
- Queen's Cancer Cenrer - POB I
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Honolulu, Hawaii, États-Unis, 96813
- Straub Clinic and Hospital
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Honolulu, Hawaii, États-Unis, 96813
- University of Hawaii Cancer Center
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Honolulu, Hawaii, États-Unis, 96817
- Queen's Cancer Center - Kuakini
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Honolulu, Hawaii, États-Unis, 96826
- Kapiolani Medical Center for Women and Children
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Honolulu, Hawaii, États-Unis, 96813
- Hawaii Cancer Care Inc-POB II
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Honolulu, Hawaii, États-Unis, 96859
- Tripler Army Medical Center
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‘Aiea, Hawaii, États-Unis, 96701
- Pali Momi Medical Center
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Illinois
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Chicago, Illinois, États-Unis, 60612
- John H Stroger Jr Hospital of Cook County
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Danville, Illinois, États-Unis, 61832
- Carle on Vermilion
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Effingham, Illinois, États-Unis, 62401
- Carle Physician Group-Effingham
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Mattoon, Illinois, États-Unis, 61938
- Carle Physician Group-Mattoon/Charleston
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Urbana, Illinois, États-Unis, 61801
- Carle Cancer Center
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Urbana, Illinois, États-Unis, 61801
- The Carle Foundation Hospital
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Iowa
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Clive, Iowa, États-Unis, 50325
- Mercy Cancer Center-West Lakes
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Clive, Iowa, États-Unis, 50325
- Medical Oncology and Hematology Associates-West Des Moines
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Creston, Iowa, États-Unis, 50801
- Greater Regional Medical Center
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Des Moines, Iowa, États-Unis, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, États-Unis, 50314
- Medical Oncology and Hematology Associates-Laurel
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West Des Moines, Iowa, États-Unis, 50266
- Mercy Medical Center-West Lakes
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Kentucky
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Lexington, Kentucky, États-Unis, 40509
- Saint Joseph Hospital East
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London, Kentucky, États-Unis, 40741
- Saint Joseph London
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Louisiana
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Monroe, Louisiana, États-Unis, 71202
- Ochsner LSU Health Monroe Medical Center
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Shreveport, Louisiana, États-Unis, 71103
- LSU Health Sciences Center at Shreveport
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Minnesota
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Bemidji, Minnesota, États-Unis, 56601
- Sanford Joe Lueken Cancer Center
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Coon Rapids, Minnesota, États-Unis, 55433
- Mercy Hospital
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Edina, Minnesota, États-Unis, 55435
- Fairview Southdale Hospital
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Fridley, Minnesota, États-Unis, 55432
- Unity Hospital
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Maplewood, Minnesota, États-Unis, 55109
- Saint John's Hospital - Healtheast
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Maplewood, Minnesota, États-Unis, 55109
- Minnesota Oncology Hematology PA-Maplewood
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Minneapolis, Minnesota, États-Unis, 55415
- Hennepin County Medical Center
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Minneapolis, Minnesota, États-Unis, 55407
- Abbott-Northwestern Hospital
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Minneapolis, Minnesota, États-Unis, 55454
- Health Partners Inc
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Robbinsdale, Minnesota, États-Unis, 55422
- North Memorial Medical Health Center
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Saint Louis Park, Minnesota, États-Unis, 55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Paul, Minnesota, États-Unis, 55101
- Regions Hospital
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Saint Paul, Minnesota, États-Unis, 55102
- United Hospital
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Shakopee, Minnesota, États-Unis, 55379
- Saint Francis Regional Medical Center
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Stillwater, Minnesota, États-Unis, 55082
- Lakeview Hospital
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Willmar, Minnesota, États-Unis, 56201
- Rice Memorial Hospital
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Woodbury, Minnesota, États-Unis, 55125
- Minnesota Oncology Hematology PA-Woodbury
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Mississippi
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Oxford, Mississippi, États-Unis, 38655
- Baptist Memorial Hospital and Cancer Center-Oxford
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Nebraska
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Grand Island, Nebraska, États-Unis, 68803
- CHI Health Saint Francis
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Nevada
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Henderson, Nevada, États-Unis, 89052
- OptumCare Cancer Care at Seven Hills
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Las Vegas, Nevada, États-Unis, 89148
- OptumCare Cancer Care at Fort Apache
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Las Vegas, Nevada, États-Unis, 89113
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
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Las Vegas, Nevada, États-Unis, 89128
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
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Las Vegas, Nevada, États-Unis, 89128
- Ann M Wierman MD LTD
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Las Vegas, Nevada, États-Unis, 89102
- OptumCare Cancer Care at Oakey
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New Mexico
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Albuquerque, New Mexico, États-Unis, 87102
- University of New Mexico Cancer Center
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Las Cruces, New Mexico, États-Unis, 88011
- Memorial Medical Center - Las Cruces
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New York
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The Bronx, New York, États-Unis, 10461
- Montefiore Medical Center-Einstein Campus
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The Bronx, New York, États-Unis, 10467
- Montefiore Medical Center - Moses Campus
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The Bronx, New York, États-Unis, 10461
- Montefiore Medical Center-Weiler Hospital
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North Dakota
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Bismarck, North Dakota, États-Unis, 58501
- Sanford Bismarck Medical Center
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Fargo, North Dakota, États-Unis, 58122
- Sanford Roger Maris Cancer Center
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Fargo, North Dakota, États-Unis, 58122
- Sanford Broadway Medical Center
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Ohio
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Belpre, Ohio, États-Unis, 45714
- Strecker Cancer Center-Belpre
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Chillicothe, Ohio, États-Unis, 45601
- Adena Regional Medical Center
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Columbus, Ohio, États-Unis, 43219
- The Mark H Zangmeister Center
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Columbus, Ohio, États-Unis, 43214
- Columbus Oncology and Hematology Associates Inc
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Marietta, Ohio, États-Unis, 45750
- Marietta Memorial Hospital
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Mount Vernon, Ohio, États-Unis, 43050
- Knox Community Hospital
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Newark, Ohio, États-Unis, 43055
- Licking Memorial Hospital
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Portsmouth, Ohio, États-Unis, 45662
- Southern Ohio Medical Center
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Oregon
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Clackamas, Oregon, États-Unis, 97015
- Clackamas Radiation Oncology Center
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Clackamas, Oregon, États-Unis, 97015
- Providence Cancer Institute Clackamas Clinic
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Newberg, Oregon, États-Unis, 97132
- Providence Newberg Medical Center
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Portland, Oregon, États-Unis, 97213
- Providence Portland Medical Center
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Portland, Oregon, États-Unis, 97225
- Providence Saint Vincent Medical Center
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Pennsylvania
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Paoli, Pennsylvania, États-Unis, 19301
- Paoli Memorial Hospital
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Wynnewood, Pennsylvania, États-Unis, 19096
- Lankenau Medical Center
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South Carolina
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Anderson, South Carolina, États-Unis, 29621
- AnMed Health Cancer Center
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Charleston, South Carolina, États-Unis, 29425
- Medical University of South Carolina
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Greer, South Carolina, États-Unis, 29651
- Gibbs Cancer Center-Pelham
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Spartanburg, South Carolina, États-Unis, 29303
- Spartanburg Medical Center
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South Dakota
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Sioux Falls, South Dakota, États-Unis, 57117-5134
- Sanford USD Medical Center - Sioux Falls
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Sioux Falls, South Dakota, États-Unis, 57104
- Sanford Cancer Center Oncology Clinic
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Tennessee
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Memphis, Tennessee, États-Unis, 38120
- Baptist Memorial Hospital and Cancer Center-Memphis
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Nashville, Tennessee, États-Unis, 37208
- Meharry Medical College
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Virginia
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Richmond, Virginia, États-Unis, 23298
- Virginia Commonwealth University/Massey Cancer Center
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Washington
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Auburn, Washington, États-Unis, 98001
- MultiCare Auburn Medical Center
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Gig Harbor, Washington, États-Unis, 98335
- MultiCare Gig Harbor Medical Park
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Puyallup, Washington, États-Unis, 98372
- MultiCare Good Samaritan Hospital
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Tacoma, Washington, États-Unis, 98405
- MultiCare Tacoma General Hospital
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Wisconsin
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Burlington, Wisconsin, États-Unis, 53105
- Aurora Cancer Care-Southern Lakes VLCC
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Fond du Lac, Wisconsin, États-Unis, 54937
- Aurora Health Center-Fond du Lac
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Grafton, Wisconsin, États-Unis, 53024
- Aurora Cancer Care-Grafton
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Green Bay, Wisconsin, États-Unis, 54311
- Aurora BayCare Medical Center
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Kenosha, Wisconsin, États-Unis, 53142
- Aurora Cancer Care-Kenosha South
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Milwaukee, Wisconsin, États-Unis, 53209
- Aurora Cancer Care-Milwaukee
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Milwaukee, Wisconsin, États-Unis, 53215
- Aurora Saint Luke's Medical Center
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New Richmond, Wisconsin, États-Unis, 54017
- Cancer Center of Western Wisconsin
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Oshkosh, Wisconsin, États-Unis, 54904
- Vince Lombardi Cancer Clinic - Oshkosh
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Sheboygan, Wisconsin, États-Unis, 53081
- Vince Lombardi Cancer Clinic-Sheboygan
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Summit, Wisconsin, États-Unis, 53066
- Aurora Medical Center in Summit
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Two Rivers, Wisconsin, États-Unis, 54241
- Vince Lombardi Cancer Clinic-Two Rivers
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Wauwatosa, Wisconsin, États-Unis, 53226
- Aurora Cancer Care-Milwaukee West
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West Allis, Wisconsin, États-Unis, 53227
- Aurora West Allis Medical Center
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Wyoming
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Cheyenne, Wyoming, États-Unis, 82001
- Cheyenne Regional Medical Center-West
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Arm A (no intervention)
Patients undergo usual standard practice related to reproductive health. |
Patients undergo usual standard practice related to reproductive health. |
|
Expérimental: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Proportion of Patients With Appropriate Reproductive Health Management
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Difference in Rating Between Patients and Their Clinicians in Importance of Fertility Maintenance
Délai: 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
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The Changes in Reproductive Health Status From Baseline to 3 Months
Délai: Baseline and 3 months
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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
|
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Associations Between Clinical and Demographic Factors and Adequacy of Reproductive Health Care Management
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Levels of Endocrine Markers of Fertility
Délai: 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)
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Ashlesha Patel, Eastern Cooperative Oncology Group
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimé)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- E1Q11
- U10CA037403 (Subvention/contrat des NIH des États-Unis)
- NCI-2012-02869 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.
Informations sur les médicaments et les dispositifs, documents d'étude
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