Clinical trial NCT01806129: Reproductive Health Program in Patients With Cancer
Official title: EROS: Engendering Reproductive Health Within Oncologic Survivorship
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Malignant Neoplasm
Keywords: reproductive health
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-03-07
Enrollment: 434
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Patients With Appropriate Reproductive Health Management
timeFrame: At baseline and 3 months
Secondary outcomes:
measure: Difference in Rating Between Patients and Their Clinicians in Importance of Fertility Maintenance
timeFrame: At baseline
measure: The Changes in Reproductive Health Status From Baseline to 3 Months
timeFrame: Baseline and 3 months
measure: Associations Between Clinical and Demographic Factors and Adequacy of Reproductive Health Care Management
timeFrame: Baseline and 3 months
Other outcomes:
measure: Levels of Endocrine Markers of Fertility
timeFrame: Baseline and 3, 6, 12, 24 months
measure: Sexual Function Score by Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: Baseline and 3, 6, 12, 24 months
Locations:
city: Jonesboro
country: United States
facility: Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
state: Arkansas
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers-Aurora
state: Colorado
city: Boulder
country: United States
facility: Rocky Mountain Cancer Centers-Boulder
state: Colorado
city: Denver
country: United States
facility: Cancer Center of Colorado at Sloan's Lake
state: Colorado
city: Lone Tree
country: United States
facility: Rocky Mountain Cancer Centers-Sky Ridge
state: Colorado
city: Wheat Ridge
country: United States
facility: SCL Health Lutheran Medical Center
state: Colorado
city: Augusta
country: United States
facility: Augusta University Medical Center
state: Georgia
city: Columbus
country: United States
facility: John B Amos Cancer Center
state: Georgia
city: 'Aiea
country: United States
facility: Pali Momi Medical Center
state: Hawaii
city: Honolulu
country: United States
facility: Hawaii Cancer Care Inc-POB II
state: Hawaii
city: Honolulu
country: United States
facility: Queen's Cancer Cenrer - POB I
state: Hawaii
city: Honolulu
country: United States
facility: Queen's Medical Center
state: Hawaii
city: Honolulu
country: United States
facility: Straub Clinic and Hospital
state: Hawaii
city: Honolulu
country: United States
facility: University of Hawaii Cancer Center
state: Hawaii
city: Honolulu
country: United States
facility: Queen's Cancer Center - Kuakini
state: Hawaii
city: Honolulu
country: United States
facility: Kapiolani Medical Center for Women and Children
state: Hawaii
city: Honolulu
country: United States
facility: Tripler Army Medical Center
state: Hawaii
city: Chicago
country: United States
facility: John H Stroger Jr Hospital of Cook County
state: Illinois
city: Danville
country: United States
facility: Carle on Vermilion
state: Illinois
city: Effingham
country: United States
facility: Carle Physician Group-Effingham
state: Illinois
city: Mattoon
country: United States
facility: Carle Physician Group-Mattoon/Charleston
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center
state: Illinois
city: Urbana
country: United States
facility: The Carle Foundation Hospital
state: Illinois
city: Clive
country: United States
facility: Medical Oncology and Hematology Associates-West Des Moines
state: Iowa
city: Clive
country: United States
facility: Mercy Cancer Center-West Lakes
state: Iowa
city: Creston
country: United States
facility: Greater Regional Medical Center
state: Iowa
city: Des Moines
country: United States
facility: Medical Oncology and Hematology Associates-Laurel
state: Iowa
city: Des Moines
country: United States
facility: Mercy Medical Center - Des Moines
state: Iowa
city: West Des Moines
country: United States
facility: Mercy Medical Center-West Lakes
state: Iowa
city: Lexington
country: United States
facility: Saint Joseph Hospital East
state: Kentucky
city: London
country: United States
facility: Saint Joseph London
state: Kentucky
city: Monroe
country: United States
facility: Ochsner LSU Health Monroe Medical Center
state: Louisiana
city: Shreveport
country: United States
facility: LSU Health Sciences Center at Shreveport
state: Louisiana
city: Bemidji
country: United States
facility: Sanford Joe Lueken Cancer Center
state: Minnesota
city: Coon Rapids
country: United States
facility: Mercy Hospital
state: Minnesota
city: Edina
country: United States
facility: Fairview Southdale Hospital
state: Minnesota
city: Fridley
country: United States
facility: Unity Hospital
state: Minnesota
city: Maplewood
country: United States
facility: Minnesota Oncology Hematology PA-Maplewood
state: Minnesota
city: Maplewood
country: United States
facility: Saint John's Hospital - Healtheast
state: Minnesota
city: Minneapolis
country: United States
facility: Abbott-Northwestern Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Minneapolis
country: United States
facility: Health Partners Inc
state: Minnesota
city: Robbinsdale
country: United States
facility: North Memorial Medical Health Center
state: Minnesota
city: Saint Louis Park
country: United States
facility: Park Nicollet Clinic - Saint Louis Park
state: Minnesota
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
city: Saint Paul
country: United States
facility: United Hospital
state: Minnesota
city: Shakopee
country: United States
facility: Saint Francis Regional Medical Center
state: Minnesota
city: Stillwater
country: United States
facility: Lakeview Hospital
state: Minnesota
city: Willmar
country: United States
facility: Rice Memorial Hospital
state: Minnesota
city: Woodbury
country: United States
facility: Minnesota Oncology Hematology PA-Woodbury
state: Minnesota
city: Oxford
country: United States
facility: Baptist Memorial Hospital and Cancer Center-Oxford
state: Mississippi
city: Grand Island
country: United States
facility: CHI Health Saint Francis
state: Nebraska
city: Henderson
country: United States
facility: OptumCare Cancer Care at Seven Hills
state: Nevada
city: Las Vegas
country: United States
facility: OptumCare Cancer Care at Oakey
state: Nevada
city: Las Vegas
country: United States
facility: HealthCare Partners Medical Group Oncology/Hematology-San Martin
state: Nevada
city: Las Vegas
country: United States
facility: Ann M Wierman MD LTD
state: Nevada
city: Las Vegas
country: United States
facility: HealthCare Partners Medical Group Oncology/Hematology-Tenaya
state: Nevada
city: Las Vegas
country: United States
facility: OptumCare Cancer Care at Fort Apache
state: Nevada
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
city: Las Cruces
country: United States
facility: Memorial Medical Center - Las Cruces
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Center-Einstein Campus
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center-Weiler Hospital
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center - Moses Campus
state: New York
city: Bismarck
country: United States
facility: Sanford Bismarck Medical Center
state: North Dakota
city: Fargo
country: United States
facility: Sanford Broadway Medical Center
state: North Dakota
city: Fargo
country: United States
facility: Sanford Roger Maris Cancer Center
state: North Dakota
city: Belpre
country: United States
facility: Strecker Cancer Center-Belpre
state: Ohio
city: Chillicothe
country: United States
facility: Adena Regional Medical Center
state: Ohio
city: Columbus
country: United States
facility: Columbus Oncology and Hematology Associates Inc
state: Ohio
city: Columbus
country: United States
facility: The Mark H Zangmeister Center
state: Ohio
city: Marietta
country: United States
facility: Marietta Memorial Hospital
state: Ohio
city: Mount Vernon
country: United States
facility: Knox Community Hospital
state: Ohio
city: Newark
country: United States
facility: Licking Memorial Hospital
state: Ohio
city: Portsmouth
country: United States
facility: Southern Ohio Medical Center
state: Ohio
city: Clackamas
country: United States
facility: Clackamas Radiation Oncology Center
state: Oregon
city: Clackamas
country: United States
facility: Providence Cancer Institute Clackamas Clinic
state: Oregon
city: Newberg
country: United States
facility: Providence Newberg Medical Center
state: Oregon
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Portland
country: United States
facility: Providence Saint Vincent Medical Center
state: Oregon
city: Paoli
country: United States
facility: Paoli Memorial Hospital
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
city: Anderson
country: United States
facility: AnMed Health Cancer Center
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Greer
country: United States
facility: Gibbs Cancer Center-Pelham
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Center
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford Cancer Center Oncology Clinic
state: South Dakota
city: Sioux Falls
country: United States
facility: Sanford USD Medical Center - Sioux Falls
state: South Dakota
city: Memphis
country: United States
facility: Baptist Memorial Hospital and Cancer Center-Memphis
state: Tennessee
city: Nashville
country: United States
facility: Meharry Medical College
state: Tennessee
city: Richmond
country: United States
facility: Virginia Commonwealth University/Massey Cancer Center
state: Virginia
city: Auburn
country: United States
facility: MultiCare Auburn Medical Center
state: Washington
city: Gig Harbor
country: United States
facility: MultiCare Gig Harbor Medical Park
state: Washington
city: Puyallup
country: United States
facility: MultiCare Good Samaritan Hospital
state: Washington
city: Tacoma
country: United States
facility: MultiCare Tacoma General Hospital
state: Washington
city: Burlington
country: United States
facility: Aurora Cancer Care-Southern Lakes VLCC
state: Wisconsin
city: Fond Du Lac
country: United States
facility: Aurora Health Center-Fond du Lac
state: Wisconsin
city: Grafton
country: United States
facility: Aurora Cancer Care-Grafton
state: Wisconsin
city: Green Bay
country: United States
facility: Aurora BayCare Medical Center
state: Wisconsin
city: Kenosha
country: United States
facility: Aurora Cancer Care-Kenosha South
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora Cancer Care-Milwaukee
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora Saint Luke's Medical Center
state: Wisconsin
city: New Richmond
country: United States
facility: Cancer Center of Western Wisconsin
state: Wisconsin
city: Oshkosh
country: United States
facility: Vince Lombardi Cancer Clinic - Oshkosh
state: Wisconsin
city: Sheboygan
country: United States
facility: Vince Lombardi Cancer Clinic-Sheboygan
state: Wisconsin
city: Summit
country: United States
facility: Aurora Medical Center in Summit
state: Wisconsin
city: Two Rivers
country: United States
facility: Vince Lombardi Cancer Clinic-Two Rivers
state: Wisconsin
city: Wauwatosa
country: United States
facility: Aurora Cancer Care-Milwaukee West
state: Wisconsin
city: West Allis
country: United States
facility: Aurora West Allis Medical Center
state: Wisconsin
city: Cheyenne
country: United States
facility: Cheyenne Regional Medical Center-West
state: Wyoming
Study officials:
affiliation: Eastern Cooperative Oncology Group
name: Ashlesha Patel
role: PRINCIPAL_INVESTIGATOR
References: