Malignant Neoplasm
Conditions
Keywords
reproductive health
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.
Interventions
OTHERStandard practice related to reproductive heath
Patients undergo usual standard practice related to reproductive health.
OTHERTraining modules, algorithm, referral development
Patients undergo reproductive health program comprising didactics, reproductive health assessment and navigating algorithm, and network development.
Sponsors
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAshlesha Patel
Eastern Cooperative Oncology Group
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Arm A (no Intervention) Patients undergo usual standard practice related to reproductive health. | 269 |
| 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. | 151 |
| Total | 420 |
Baseline characteristics
| Characteristic | Arm B (Reproductive Health Program) | Total | Arm A (no Intervention) |
|---|---|---|---|
| Age, Continuous | 39 years | 41 years | 41 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 40 Participants | 67 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 108 Participants | 337 Participants | 229 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 16 Participants | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 29 Participants | 24 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants | 82 Participants | 56 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 8 Participants | 7 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 35 Participants | 31 Participants |
| Race (NIH/OMB) White | 114 Participants | 262 Participants | 148 Participants |
| Sex: Female, Male Female | 151 Participants | 420 Participants | 269 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 10 / 278 | 7 / 156 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: At baseline and 3 months
Population: Only eligible patients who were evaluable for the primary endpoint were included in the analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A (no Intervention) | Proportion of Patients With Appropriate Reproductive Health Management | With appropriate reproductive health management | 116 Participants |
| Arm A (no Intervention) | Proportion of Patients With Appropriate Reproductive Health Management | Without appropriate reproductive health management | 129 Participants |
| Arm B (Reproductive Health Program) | Proportion of Patients With Appropriate Reproductive Health Management | Without appropriate reproductive health management | 46 Participants |
| Arm B (Reproductive Health Program) | Proportion of Patients With Appropriate Reproductive Health Management | With appropriate reproductive health management | 88 Participants |
90% CI: [1.29, 3.31]
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.
Time frame: Baseline and 3 months
Population: Eligible patients with primary endpoint evaluated were included in this analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Arm A (no Intervention) | Associations Between Clinical and Demographic Factors and Adequacy of Reproductive Health Care Management | Completed childbearing at baseline | With appropriate reproductive health management | 79 Participants |
| Arm A (no Intervention) | Associations Between Clinical and Demographic Factors and Adequacy of Reproductive Health Care Management | Completed childbearing at baseline | Without appropriate reproductive health management | 80 Participants |
| Arm A (no Intervention) | Associations Between Clinical and Demographic Factors and Adequacy of Reproductive Health Care Management | Childbearing not completed at baseline | With appropriate reproductive health management | 37 Participants |
| Arm A (no Intervention) | Associations Between Clinical and Demographic Factors and Adequacy of Reproductive Health Care Management | Childbearing not completed at baseline | Without appropriate reproductive health management | 49 Participants |
| Arm B (Reproductive Health Program) | Associations Between Clinical and Demographic Factors and Adequacy of Reproductive Health Care Management | Childbearing not completed at baseline | Without appropriate reproductive health management | 25 Participants |
| Arm B (Reproductive Health Program) | Associations Between Clinical and Demographic Factors and Adequacy of Reproductive Health Care Management | Completed childbearing at baseline | With appropriate reproductive health management | 62 Participants |
| Arm B (Reproductive Health Program) | Associations Between Clinical and Demographic Factors and Adequacy of Reproductive Health Care Management | Childbearing not completed at baseline | With appropriate reproductive health management | 26 Participants |
| Arm B (Reproductive Health Program) | Associations Between Clinical and Demographic Factors and Adequacy of Reproductive Health Care Management | Completed childbearing at baseline | Without appropriate reproductive health management | 21 Participants |
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.
Time frame: At baseline
Population: Patients with both patient rating and physician rating available were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A (no Intervention) | Difference in Rating Between Patients and Their Clinicians in Importance of Fertility Maintenance | 0.03 score on a scale | Standard Deviation 0.67 |
| Arm B (Reproductive Health Program) | Difference in Rating Between Patients and Their Clinicians in Importance of Fertility Maintenance | 0.12 score on a scale | Standard Deviation 0.67 |
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
Time frame: Baseline and 3 months
Population: All eligible/analyzable patients were included in the analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Arm A (no Intervention) | The Changes in Reproductive Health Status From Baseline to 3 Months | Baseline | Sexuality unknown & childbearing not completed at 3 months | 2 Participants |
| Arm A (no Intervention) | The Changes in Reproductive Health Status From Baseline to 3 Months | Baseline | Missing/Unknown at 3 months | 0 Participants |
| Arm A (no Intervention) | The Changes in Reproductive Health Status From Baseline to 3 Months | 3 months | Sextually active & childbearing completed at 3 months | 88 Participants |
| Arm A (no Intervention) | The Changes in Reproductive Health Status From Baseline to 3 Months | 3 months | Sextually not active & childbearing not completed at 3 months | 20 Participants |
| Arm A (no Intervention) | The Changes in Reproductive Health Status From Baseline to 3 Months | Baseline | Sextually active & childbearing not completed at 3 months | 52 Participants |
| Arm A (no Intervention) | The Changes in Reproductive Health Status From Baseline to 3 Months | Baseline | Sextually active & childbearing completed at 3 months | 109 Participants |
| Arm A (no Intervention) | The Changes in Reproductive Health Status From Baseline to 3 Months | Baseline | Sextually not active & childbearing not completed at 3 months | 32 Participants |
| Arm A (no Intervention) | The Changes in Reproductive Health Status From Baseline to 3 Months | Baseline | Sextually not active & childbearing completed at 3 months | 62 Participants |
| Arm A (no Intervention) | The Changes in Reproductive Health Status From Baseline to 3 Months | Baseline | Sexuality unknown & childbearing completed at 3 months | 3 Participants |
| Arm A (no Intervention) | The Changes in Reproductive Health Status From Baseline to 3 Months | Baseline | Pregnant/Pregnancy in 1 year at 3 months | 9 Participants |
| Arm A (no Intervention) | The Changes in Reproductive Health Status From Baseline to 3 Months | 3 months | Sextually active & childbearing not completed at 3 months | 37 Participants |
| Arm A (no Intervention) | The Changes in Reproductive Health Status From Baseline to 3 Months | 3 months | Sextually not active & childbearing completed at 3 months | 71 Participants |
| Arm A (no Intervention) | The Changes in Reproductive Health Status From Baseline to 3 Months | 3 months | Sexuality unknown & childbearing not completed at 3 months | 0 Participants |
| Arm A (no Intervention) | The Changes in Reproductive Health Status From Baseline to 3 Months | 3 months | Sexuality unknown & childbearing completed at 3 months | 2 Participants |
| Arm A (no Intervention) | The Changes in Reproductive Health Status From Baseline to 3 Months | 3 months | Pregnant/Pregnancy in 1 year at 3 months | 18 Participants |
| Arm A (no Intervention) | The Changes in Reproductive Health Status From Baseline to 3 Months | 3 months | Missing/Unknown at 3 months | 33 Participants |
| Arm B (Reproductive Health Program) | The Changes in Reproductive Health Status From Baseline to 3 Months | 3 months | Sextually not active & childbearing not completed at 3 months | 10 Participants |
| Arm B (Reproductive Health Program) | The Changes in Reproductive Health Status From Baseline to 3 Months | Baseline | Sexuality unknown & childbearing completed at 3 months | 0 Participants |
| Arm B (Reproductive Health Program) | The Changes in Reproductive Health Status From Baseline to 3 Months | Baseline | Sextually not active & childbearing completed at 3 months | 35 Participants |
| Arm B (Reproductive Health Program) | The Changes in Reproductive Health Status From Baseline to 3 Months | Baseline | Missing/Unknown at 3 months | 0 Participants |
| Arm B (Reproductive Health Program) | The Changes in Reproductive Health Status From Baseline to 3 Months | 3 months | Sextually active & childbearing not completed at 3 months | 14 Participants |
| Arm B (Reproductive Health Program) | The Changes in Reproductive Health Status From Baseline to 3 Months | Baseline | Sexuality unknown & childbearing not completed at 3 months | 0 Participants |
| Arm B (Reproductive Health Program) | The Changes in Reproductive Health Status From Baseline to 3 Months | 3 months | Sextually active & childbearing completed at 3 months | 45 Participants |
| Arm B (Reproductive Health Program) | The Changes in Reproductive Health Status From Baseline to 3 Months | 3 months | Missing/Unknown at 3 months | 28 Participants |
| Arm B (Reproductive Health Program) | The Changes in Reproductive Health Status From Baseline to 3 Months | 3 months | Sextually not active & childbearing completed at 3 months | 37 Participants |
| Arm B (Reproductive Health Program) | The Changes in Reproductive Health Status From Baseline to 3 Months | 3 months | Pregnant/Pregnancy in 1 year at 3 months | 15 Participants |
| Arm B (Reproductive Health Program) | The Changes in Reproductive Health Status From Baseline to 3 Months | 3 months | Sexuality unknown & childbearing completed at 3 months | 2 Participants |
| Arm B (Reproductive Health Program) | The Changes in Reproductive Health Status From Baseline to 3 Months | Baseline | Sextually active & childbearing not completed at 3 months | 34 Participants |
| Arm B (Reproductive Health Program) | The Changes in Reproductive Health Status From Baseline to 3 Months | Baseline | Pregnant/Pregnancy in 1 year at 3 months | 4 Participants |
| Arm B (Reproductive Health Program) | The Changes in Reproductive Health Status From Baseline to 3 Months | Baseline | Sextually active & childbearing completed at 3 months | 58 Participants |
| Arm B (Reproductive Health Program) | The Changes in Reproductive Health Status From Baseline to 3 Months | 3 months | Sexuality unknown & childbearing not completed at 3 months | 0 Participants |
| Arm B (Reproductive Health Program) | The Changes in Reproductive Health Status From Baseline to 3 Months | Baseline | Sextually not active & childbearing not completed at 3 months | 20 Participants |
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.
Time frame: Baseline and 3, 6, 12, 24 months
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.
Time frame: Baseline and 3, 6, 12, 24 months