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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01806129
Other study ID # E1Q11
Secondary ID NCI-2012-02869U1
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 2, 2016
Est. completion date April 30, 2025

Study information

Verified date February 2024
Source Eastern Cooperative Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Active, not recruiting
Enrollment 434
Est. completion date April 30, 2025
Est. primary completion date July 31, 2021
Accepts healthy volunteers No
Gender Female
Age group 15 Years to 55 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Standard practice related to reproductive heath
Patients undergo usual standard practice related to reproductive health.
Training modules, algorithm, referral development
Patients undergo reproductive health program comprising didactics, reproductive health assessment and navigating algorithm, and network development.

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
ECOG-ACRIN Cancer Research Group National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Levels of Endocrine Markers of Fertility 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
Other Sexual Function Score by Patient-Reported Outcomes Measurement Information System (PROMIS) 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
Primary Proportion of Patients With Appropriate Reproductive Health Management 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
Secondary Difference in Rating Between Patients and Their Clinicians in Importance of Fertility Maintenance 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
Secondary The Changes in Reproductive Health Status From Baseline to 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
Baseline and 3 months
Secondary Associations Between Clinical and Demographic Factors and Adequacy of Reproductive Health Care Management 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
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