Reproductive Health Program in Patients With Cancer

Not Applicable

Active, not recruiting

Conditions: Malignant Neoplasm

Interventions: Other: Standard practice related to reproductive heath
Other: Training modules, algorithm, referral development

Registration Number: NCT01806129

Lead Sponsor: ECOG-ACRIN Cancer Research Group

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.

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: Female

Target Recruitment: 434

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A (no intervention)	Standard practice related to reproductive heath	Patients undergo usual standard practice related to reproductive health.
Arm B (reproductive health program)	Training modules, algorithm, referral development	Patients undergo reproductive health program comprising didactics, reproductive health assessment and navigating algorithm, and network development.

Primary Outcome Measures

Name	Time	Method
Proportion of Patients With Appropriate Reproductive Health Management	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.

Secondary Outcome Measures

Name	Time	Method
Difference in Rating Between Patients and Their Clinicians in Importance of Fertility Maintenance	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.
The Changes in Reproductive Health Status From Baseline to 3 Months	Baseline and 3 months	Patient's reproductive health choices relating to oncofertility, oncocontraception and pregnancy was assessed at baseline and 3 months. Patient's reproductive health status is categorized into the following categories: * Sextually active \& childbearing not completed * Sextually active \& childbearing completed * Sextually not active \& childbearing not completed * Sextually not active \& childbearing completed * Sexuality unknown \& childbearing not completed * Sexuality unknown \& childbearing completed * Pregnant/Pregnancy in 1 year * Missing/Unknown
Associations Between Clinical and Demographic Factors and Adequacy of Reproductive Health Care Management	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.

Trial Locations

Locations (109): The Mark H Zangmeister Center
🇺🇸
Columbus, Ohio, United States
OptumCare Cancer Care at Oakey
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Las Vegas, Nevada, United States
HealthCare Partners Medical Group Oncology/Hematology-San Martin
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Las Vegas, Nevada, United States
HealthCare Partners Medical Group Oncology/Hematology-Tenaya
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Las Vegas, Nevada, United States
OptumCare Cancer Care at Fort Apache
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Las Vegas, Nevada, United States
Pali Momi Medical Center
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'Aiea, Hawaii, United States
Sanford Broadway Medical Center
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Fargo, North Dakota, United States
Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
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Jonesboro, Arkansas, United States
Rocky Mountain Cancer Centers-Boulder
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Boulder, Colorado, United States
SCL Health Lutheran Medical Center
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Wheat Ridge, Colorado, United States
Augusta University Medical Center
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Augusta, Georgia, United States
John H Stroger Jr Hospital of Cook County
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Chicago, Illinois, United States
Carle on Vermilion
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Danville, Illinois, United States
Carle Cancer Center
🇺🇸
Urbana, Illinois, United States
Medical Oncology and Hematology Associates-West Des Moines
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Clive, Iowa, United States
Greater Regional Medical Center
🇺🇸
Creston, Iowa, United States
Saint Joseph London
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London, Kentucky, United States
Regions Hospital
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Saint Paul, Minnesota, United States
United Hospital
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Saint Paul, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park
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Saint Louis Park, Minnesota, United States
Minnesota Oncology Hematology PA-Woodbury
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Woodbury, Minnesota, United States
Rice Memorial Hospital
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Willmar, Minnesota, United States
Saint Francis Regional Medical Center
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Shakopee, Minnesota, United States
Sanford Bismarck Medical Center
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Bismarck, North Dakota, United States
Southern Ohio Medical Center
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Portsmouth, Ohio, United States
Columbus Oncology and Hematology Associates Inc
🇺🇸
Columbus, Ohio, United States
Sanford Roger Maris Cancer Center
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Fargo, North Dakota, United States
Knox Community Hospital
🇺🇸
Mount Vernon, Ohio, United States
Licking Memorial Hospital
🇺🇸
Newark, Ohio, United States
Marietta Memorial Hospital
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Marietta, Ohio, United States
Clackamas Radiation Oncology Center
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Clackamas, Oregon, United States
Providence Cancer Institute Clackamas Clinic
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Clackamas, Oregon, United States
Providence Newberg Medical Center
🇺🇸
Newberg, Oregon, United States
Paoli Memorial Hospital
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Paoli, Pennsylvania, United States
Gibbs Cancer Center-Pelham
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Greer, South Carolina, United States
Sanford Cancer Center Oncology Clinic
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Sioux Falls, South Dakota, United States
MultiCare Gig Harbor Medical Park
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Gig Harbor, Washington, United States
MultiCare Good Samaritan Hospital
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Puyallup, Washington, United States
MultiCare Tacoma General Hospital
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Tacoma, Washington, United States
Aurora Cancer Care-Southern Lakes VLCC
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Burlington, Wisconsin, United States
Aurora Cancer Care-Grafton
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Grafton, Wisconsin, United States
Vince Lombardi Cancer Clinic - Oshkosh
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Oshkosh, Wisconsin, United States
Cancer Center of Western Wisconsin
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New Richmond, Wisconsin, United States
Vince Lombardi Cancer Clinic-Two Rivers
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Two Rivers, Wisconsin, United States
Aurora West Allis Medical Center
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West Allis, Wisconsin, United States
Aurora Cancer Care-Milwaukee West
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Wauwatosa, Wisconsin, United States
Cheyenne Regional Medical Center-West
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Cheyenne, Wyoming, United States
Hawaii Cancer Care Inc-POB II
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Honolulu, Hawaii, United States
Queen's Cancer Cenrer - POB I
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Honolulu, Hawaii, United States
Queen's Medical Center
🇺🇸
Honolulu, Hawaii, United States
Straub Clinic and Hospital
🇺🇸
Honolulu, Hawaii, United States
University of Hawaii Cancer Center
🇺🇸
Honolulu, Hawaii, United States
Queen's Cancer Center - Kuakini
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Honolulu, Hawaii, United States
Rocky Mountain Cancer Centers-Sky Ridge
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Lone Tree, Colorado, United States
Aurora BayCare Medical Center
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Green Bay, Wisconsin, United States
Rocky Mountain Cancer Centers-Aurora
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Aurora, Colorado, United States
Cancer Center of Colorado at Sloan's Lake
🇺🇸
Denver, Colorado, United States
Abbott-Northwestern Hospital
🇺🇸
Minneapolis, Minnesota, United States
Hennepin County Medical Center
🇺🇸
Minneapolis, Minnesota, United States
Health Partners Inc
🇺🇸
Minneapolis, Minnesota, United States
Providence Portland Medical Center
🇺🇸
Portland, Oregon, United States
Meharry Medical College
🇺🇸
Nashville, Tennessee, United States
Providence Saint Vincent Medical Center
🇺🇸
Portland, Oregon, United States
Aurora Cancer Care-Milwaukee
🇺🇸
Milwaukee, Wisconsin, United States
Aurora Saint Luke's Medical Center
🇺🇸
Milwaukee, Wisconsin, United States
The Carle Foundation Hospital
🇺🇸
Urbana, Illinois, United States
OptumCare Cancer Care at Seven Hills
🇺🇸
Henderson, Nevada, United States
John B Amos Cancer Center
🇺🇸
Columbus, Georgia, United States
Carle Physician Group-Effingham
🇺🇸
Effingham, Illinois, United States
Carle Physician Group-Mattoon/Charleston
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Mattoon, Illinois, United States
Mercy Cancer Center-West Lakes
🇺🇸
Clive, Iowa, United States
Mercy Medical Center-West Lakes
🇺🇸
West Des Moines, Iowa, United States
LSU Health Sciences Center at Shreveport
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Shreveport, Louisiana, United States
Unity Hospital
🇺🇸
Fridley, Minnesota, United States
Ochsner LSU Health Monroe Medical Center
🇺🇸
Monroe, Louisiana, United States
Sanford Joe Lueken Cancer Center
🇺🇸
Bemidji, Minnesota, United States
Fairview Southdale Hospital
🇺🇸
Edina, Minnesota, United States
Mercy Hospital
🇺🇸
Coon Rapids, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood
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Maplewood, Minnesota, United States
Saint John's Hospital - Healtheast
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Maplewood, Minnesota, United States
North Memorial Medical Health Center
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Robbinsdale, Minnesota, United States
CHI Health Saint Francis
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Grand Island, Nebraska, United States
University of New Mexico Cancer Center
🇺🇸
Albuquerque, New Mexico, United States
Memorial Medical Center - Las Cruces
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Las Cruces, New Mexico, United States
Strecker Cancer Center-Belpre
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Belpre, Ohio, United States
Adena Regional Medical Center
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Chillicothe, Ohio, United States
Lankenau Medical Center
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Wynnewood, Pennsylvania, United States
MultiCare Auburn Medical Center
🇺🇸
Auburn, Washington, United States
Vince Lombardi Cancer Clinic-Sheboygan
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Sheboygan, Wisconsin, United States
Aurora Cancer Care-Kenosha South
🇺🇸
Kenosha, Wisconsin, United States
Aurora Medical Center in Summit
🇺🇸
Summit, Wisconsin, United States
Baptist Memorial Hospital and Cancer Center-Memphis
🇺🇸
Memphis, Tennessee, United States
Ann M Wierman MD LTD
🇺🇸
Las Vegas, Nevada, United States
Baptist Memorial Hospital and Cancer Center-Oxford
🇺🇸
Oxford, Mississippi, United States
Spartanburg Medical Center
🇺🇸
Spartanburg, South Carolina, United States
AnMed Health Cancer Center
🇺🇸
Anderson, South Carolina, United States
Sanford USD Medical Center - Sioux Falls
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Sioux Falls, South Dakota, United States
Kapiolani Medical Center for Women and Children
🇺🇸
Honolulu, Hawaii, United States
Tripler Army Medical Center
🇺🇸
Honolulu, Hawaii, United States
Medical Oncology and Hematology Associates-Laurel
🇺🇸
Des Moines, Iowa, United States
Mercy Medical Center - Des Moines
🇺🇸
Des Moines, Iowa, United States
Saint Joseph Hospital East
🇺🇸
Lexington, Kentucky, United States
Montefiore Medical Center-Einstein Campus
🇺🇸
Bronx, New York, United States
Montefiore Medical Center-Weiler Hospital
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Bronx, New York, United States
Montefiore Medical Center - Moses Campus
🇺🇸
Bronx, New York, United States
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States
Virginia Commonwealth University/Massey Cancer Center
🇺🇸
Richmond, Virginia, United States
Lakeview Hospital
🇺🇸
Stillwater, Minnesota, United States
Aurora Health Center-Fond du Lac
🇺🇸
Fond Du Lac, Wisconsin, United States