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.
Brief Title
Reproductive Health Program in Patients With Cancer
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.
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.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Malignant Neoplasm
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
* 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
Inclusion 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
* 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
Gender
Female
Gender Based
false
Keywords
reproductive health
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
55 Years
Minimum Age
15 Years
NCT Id
NCT01806129
Org Class
Network
Org Full Name
Eastern Cooperative Oncology Group
Org Study Id
E1Q11
Overall Status
Active, not recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
EROS: Engendering Reproductive Health Within Oncologic Survivorship
Primary Outcomes
Outcome Description
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.
Outcome Measure
Proportion of Patients With Appropriate Reproductive Health Management
Outcome Time Frame
At baseline and 3 months
Secondary Ids
Secondary Id
NCI-2012-02869
Secondary Id
U10CA037403
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
At baseline
Outcome Measure
Difference in Rating Between Patients and Their Clinicians in Importance of Fertility Maintenance
Outcome Description
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
* 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
Outcome Time Frame
Baseline and 3 months
Outcome Measure
The Changes in Reproductive Health Status From Baseline to 3 Months
Outcome Description
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.
Outcome Time Frame
Baseline and 3 months
Outcome Measure
Associations Between Clinical and Demographic Factors and Adequacy of Reproductive Health Care Management
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Maximum Age Number (converted to Years and rounded down)
55
Minimum Age Number (converted to Years and rounded down)
15
Investigators
Investigator Type
Principal Investigator
Investigator Name
Della Makower
Investigator Email
DMAKOWER@montefiore.org
Investigator Phone