Reproductive Health Program in Patients With Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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EROS: Engendering Reproductive Health Within Oncologic Survivorship

Conditions
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Malignant Neoplasm

Intervention / Treatment
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* Other: Standard practice related to reproductive heath
* Other: Training modules, algorithm, referral development


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A (no intervention)<br>Patients undergo usual standard practice related to reproductive health. | Other: Standard practice related to reproductive heath<br>* Patients undergo usual standard practice related to reproductive health.<br>|
| Experimental: Arm B (reproductive health program)<br>Patients undergo reproductive health program comprising didactics, reproductive health assessment and navigating algorithm, and network development. | Other: Training modules, algorithm, referral development<br>* Patients undergo reproductive health program comprising didactics, reproductive health assessment and navigating algorithm, and network development.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consistency Rate Between Patients and Their Clinicians in Estimates of Significance of the Reproductive Health Goals for the Patient | The ratings on the reproductive health value questions (each on a 1-10 scale) were assessed among patients and the corresponding treating physicians. The consistency rate between patients and their physicians is to be reported. Higher scores indicate more importance of the target reproductive health goal. | At baseline and 3, 6, 12, 24 months | 
| The Distribution of the Usage of Contraceptive Methods | The usage of contraceptive methods were evaluated at baseline, 3, 6, 12, and 24 months and the distribution over time is to be reported by arm. | Baseline and 3, 6, 12, 24 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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reproductive health