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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-02869 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| U10CA037403 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (no intervention) | Active Comparator | Patients undergo usual standard practice related to reproductive health. |
|
| Arm B (reproductive health program) | Experimental | Patients undergo reproductive health program comprising didactics, reproductive health assessment and navigating algorithm, and network development. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard practice related to reproductive heath | Other | Patients undergo usual standard practice related to reproductive health. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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:
Pregnant women are eligible to participate in this study
Patients must have the cognitive ability to participate in the study
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashlesha Patel | Eastern Cooperative Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro | Jonesboro | Arkansas | 72401 | United States | ||
Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.
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This study was activated on September 30, 2015 for site start-up preparation, opened to accrual on July 14, 2016, accrued its first patient on September 2, 2016, and closed to accrual on April 28, 2021 with a total of 434 patients accrued by 17 NCI Community Oncology Research Program (NCORP) sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A (no Intervention) | Patients undergo usual standard practice related to reproductive health. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 17, 2021 |
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| Training modules, algorithm, referral development | Other | Patients undergo reproductive health program comprising didactics, reproductive health assessment and navigating algorithm, and network development. |
|
| At baseline |
| 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:
| Baseline and 3 months |
| 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 |
| 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 |
| Rocky Mountain Cancer Centers-Aurora |
| Aurora |
| Colorado |
| 80012 |
| United States |
| Rocky Mountain Cancer Centers-Boulder | Boulder | Colorado | 80304 | United States |
| Cancer Center of Colorado at Sloan's Lake | Denver | Colorado | 80204 | United States |
| Rocky Mountain Cancer Centers-Sky Ridge | Lone Tree | Colorado | 80124 | United States |
| SCL Health Lutheran Medical Center | Wheat Ridge | Colorado | 80033 | United States |
| Augusta University Medical Center | Augusta | Georgia | 30912 | United States |
| John B Amos Cancer Center | Columbus | Georgia | 31904 | United States |
| Hawaii Cancer Care Inc-POB II | Honolulu | Hawaii | 96813 | United States |
| Queen's Cancer Cenrer - POB I | Honolulu | Hawaii | 96813 | United States |
| Queen's Medical Center | Honolulu | Hawaii | 96813 | United States |
| Straub Clinic and Hospital | Honolulu | Hawaii | 96813 | United States |
| University of Hawaii Cancer Center | Honolulu | Hawaii | 96813 | United States |
| Queen's Cancer Center - Kuakini | Honolulu | Hawaii | 96817 | United States |
| Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | 96826 | United States |
| Tripler Army Medical Center | Honolulu | Hawaii | 96859 | United States |
| Pali Momi Medical Center | ‘Aiea | Hawaii | 96701 | United States |
| John H Stroger Jr Hospital of Cook County | Chicago | Illinois | 60612 | United States |
| Carle on Vermilion | Danville | Illinois | 61832 | United States |
| Carle Physician Group-Effingham | Effingham | Illinois | 62401 | United States |
| Carle Physician Group-Mattoon/Charleston | Mattoon | Illinois | 61938 | United States |
| Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| The Carle Foundation Hospital | Urbana | Illinois | 61801 | United States |
| Medical Oncology and Hematology Associates-West Des Moines | Clive | Iowa | 50325 | United States |
| Mercy Cancer Center-West Lakes | Clive | Iowa | 50325 | United States |
| Greater Regional Medical Center | Creston | Iowa | 50801 | United States |
| Medical Oncology and Hematology Associates-Laurel | Des Moines | Iowa | 50314 | United States |
| Mercy Medical Center - Des Moines | Des Moines | Iowa | 50314 | United States |
| Mercy Medical Center-West Lakes | West Des Moines | Iowa | 50266 | United States |
| Saint Joseph Hospital East | Lexington | Kentucky | 40509 | United States |
| Saint Joseph London | London | Kentucky | 40741 | United States |
| Ochsner LSU Health Monroe Medical Center | Monroe | Louisiana | 71202 | United States |
| LSU Health Sciences Center at Shreveport | Shreveport | Louisiana | 71103 | United States |
| Sanford Joe Lueken Cancer Center | Bemidji | Minnesota | 56601 | United States |
| Mercy Hospital | Coon Rapids | Minnesota | 55433 | United States |
| Fairview Southdale Hospital | Edina | Minnesota | 55435 | United States |
| Unity Hospital | Fridley | Minnesota | 55432 | United States |
| Minnesota Oncology Hematology PA-Maplewood | Maplewood | Minnesota | 55109 | United States |
| Saint John's Hospital - Healtheast | Maplewood | Minnesota | 55109 | United States |
| Abbott-Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
| Health Partners Inc | Minneapolis | Minnesota | 55454 | United States |
| North Memorial Medical Health Center | Robbinsdale | Minnesota | 55422 | United States |
| Park Nicollet Clinic - Saint Louis Park | Saint Louis Park | Minnesota | 55416 | United States |
| Regions Hospital | Saint Paul | Minnesota | 55101 | United States |
| United Hospital | Saint Paul | Minnesota | 55102 | United States |
| Saint Francis Regional Medical Center | Shakopee | Minnesota | 55379 | United States |
| Lakeview Hospital | Stillwater | Minnesota | 55082 | United States |
| Rice Memorial Hospital | Willmar | Minnesota | 56201 | United States |
| Minnesota Oncology Hematology PA-Woodbury | Woodbury | Minnesota | 55125 | United States |
| Baptist Memorial Hospital and Cancer Center-Oxford | Oxford | Mississippi | 38655 | United States |
| CHI Health Saint Francis | Grand Island | Nebraska | 68803 | United States |
| OptumCare Cancer Care at Seven Hills | Henderson | Nevada | 89052 | United States |
| OptumCare Cancer Care at Oakey | Las Vegas | Nevada | 89102 | United States |
| HealthCare Partners Medical Group Oncology/Hematology-San Martin | Las Vegas | Nevada | 89113 | United States |
| Ann M Wierman MD LTD | Las Vegas | Nevada | 89128 | United States |
| HealthCare Partners Medical Group Oncology/Hematology-Tenaya | Las Vegas | Nevada | 89128 | United States |
| OptumCare Cancer Care at Fort Apache | Las Vegas | Nevada | 89148 | United States |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87102 | United States |
| Memorial Medical Center - Las Cruces | Las Cruces | New Mexico | 88011 | United States |
| Montefiore Medical Center-Einstein Campus | The Bronx | New York | 10461 | United States |
| Montefiore Medical Center-Weiler Hospital | The Bronx | New York | 10461 | United States |
| Montefiore Medical Center - Moses Campus | The Bronx | New York | 10467 | United States |
| Sanford Bismarck Medical Center | Bismarck | North Dakota | 58501 | United States |
| Sanford Broadway Medical Center | Fargo | North Dakota | 58122 | United States |
| Sanford Roger Maris Cancer Center | Fargo | North Dakota | 58122 | United States |
| Strecker Cancer Center-Belpre | Belpre | Ohio | 45714 | United States |
| Adena Regional Medical Center | Chillicothe | Ohio | 45601 | United States |
| Columbus Oncology and Hematology Associates Inc | Columbus | Ohio | 43214 | United States |
| The Mark H Zangmeister Center | Columbus | Ohio | 43219 | United States |
| Marietta Memorial Hospital | Marietta | Ohio | 45750 | United States |
| Knox Community Hospital | Mount Vernon | Ohio | 43050 | United States |
| Licking Memorial Hospital | Newark | Ohio | 43055 | United States |
| Southern Ohio Medical Center | Portsmouth | Ohio | 45662 | United States |
| Clackamas Radiation Oncology Center | Clackamas | Oregon | 97015 | United States |
| Providence Cancer Institute Clackamas Clinic | Clackamas | Oregon | 97015 | United States |
| Providence Newberg Medical Center | Newberg | Oregon | 97132 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| Providence Saint Vincent Medical Center | Portland | Oregon | 97225 | United States |
| Paoli Memorial Hospital | Paoli | Pennsylvania | 19301 | United States |
| Lankenau Medical Center | Wynnewood | Pennsylvania | 19096 | United States |
| AnMed Health Cancer Center | Anderson | South Carolina | 29621 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Gibbs Cancer Center-Pelham | Greer | South Carolina | 29651 | United States |
| Spartanburg Medical Center | Spartanburg | South Carolina | 29303 | United States |
| Sanford Cancer Center Oncology Clinic | Sioux Falls | South Dakota | 57104 | United States |
| Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | 57117-5134 | United States |
| Baptist Memorial Hospital and Cancer Center-Memphis | Memphis | Tennessee | 38120 | United States |
| Meharry Medical College | Nashville | Tennessee | 37208 | United States |
| Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia | 23298 | United States |
| MultiCare Auburn Medical Center | Auburn | Washington | 98001 | United States |
| MultiCare Gig Harbor Medical Park | Gig Harbor | Washington | 98335 | United States |
| MultiCare Good Samaritan Hospital | Puyallup | Washington | 98372 | United States |
| MultiCare Tacoma General Hospital | Tacoma | Washington | 98405 | United States |
| Aurora Cancer Care-Southern Lakes VLCC | Burlington | Wisconsin | 53105 | United States |
| Aurora Health Center-Fond du Lac | Fond du Lac | Wisconsin | 54937 | United States |
| Aurora Cancer Care-Grafton | Grafton | Wisconsin | 53024 | United States |
| Aurora BayCare Medical Center | Green Bay | Wisconsin | 54311 | United States |
| Aurora Cancer Care-Kenosha South | Kenosha | Wisconsin | 53142 | United States |
| Aurora Cancer Care-Milwaukee | Milwaukee | Wisconsin | 53209 | United States |
| Aurora Saint Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
| Cancer Center of Western Wisconsin | New Richmond | Wisconsin | 54017 | United States |
| Vince Lombardi Cancer Clinic - Oshkosh | Oshkosh | Wisconsin | 54904 | United States |
| Vince Lombardi Cancer Clinic-Sheboygan | Sheboygan | Wisconsin | 53081 | United States |
| Aurora Medical Center in Summit | Summit | Wisconsin | 53066 | United States |
| Vince Lombardi Cancer Clinic-Two Rivers | Two Rivers | Wisconsin | 54241 | United States |
| Aurora Cancer Care-Milwaukee West | Wauwatosa | Wisconsin | 53226 | United States |
| Aurora West Allis Medical Center | West Allis | Wisconsin | 53227 | United States |
| Cheyenne Regional Medical Center-West | Cheyenne | Wyoming | 82001 | United States |
| Eligible and Analyzable Patients |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Only eligible patients were included in this analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A (no Intervention) | Patients undergo usual standard practice related to reproductive health. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Only eligible patients who were evaluable for the primary endpoint were included in the analysis. | Posted | Count of Participants | Participants | At baseline and 3 months |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Patients with both patient rating and physician rating available were included in this analysis. | Posted | Mean | Standard Deviation | score on a scale | At baseline |
|
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| 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:
| All eligible/analyzable patients were included in the analysis. | Posted | Count of Participants | Participants | 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. | Eligible patients with primary endpoint evaluated were included in this analysis. | Posted | Count of Participants | Participants | Baseline and 3 months |
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| Other Pre-specified | 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. | Not Posted | Baseline and 3, 6, 12, 24 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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. | Not Posted | Baseline and 3, 6, 12, 24 months | Participants |
Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A (no Intervention) | Patients undergo usual standard practice related to reproductive health. | 10 | 278 | 0 | 0 | 0 | 0 |
| EG001 | 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. | 7 | 156 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Statistician | ECOG-ACRIN Statistical Office | 617-632-3012 | eatrials@jimmy.harvard.edu |
| Sep 6, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000465 | Algorithms |
| ID | Term |
|---|---|
| D055641 | Mathematical Concepts |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Participants |
|
|
|
|
| Sextually not active & childbearing not completed at 3 months |
|
| Sextually not active & childbearing completed at 3 months |
|
| Sexuality unknown & childbearing not completed at 3 months |
|
| Sexuality unknown & childbearing completed at 3 months |
|
| Pregnant/Pregnancy in 1 year at 3 months |
|
| Missing/Unknown at 3 months |
|
| Without appropriate reproductive health management |
|