Patients undergo usual standard practice related to reproductive health.

Patients undergo reproductive health program comprising didactics, reproductive health assessment and navigating algorithm, and network development.

Standard practice related to reproductive heath

Training modules, algorithm, referral development

Ashlesha Patel

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.

Reproductive Health Program in Patients With Cancer

EROS: Engendering Reproductive Health Within Oncologic Survivorship

Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.

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.

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.

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.

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.

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

National Cancer Institute (NCI)

ECOG-ACRIN Cancer Research Group

Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.

Arm A (no Intervention)

Training modules, algorithm, referral development: Patients undergo reproductive health program comprising didactics, reproductive health assessment and navigating algorithm, and network development.

Arm B (Reproductive Health Program)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Only eligible patients were included in this analysis.

Study Statistician

Only eligible patients who were evaluable for the primary endpoint were included in the analysis.

Proportion of Patients With Appropriate Reproductive Health Management

Patients with both patient rating and physician rating available were included in this analysis.

Difference in Rating Between Patients and Their Clinicians in Importance of Fertility Maintenance

Baseline

3 months

All eligible/analyzable patients were included in the analysis.

The Changes in Reproductive Health Status From Baseline to 3 Months

Completed childbearing at baseline

Childbearing not completed at baseline

Eligible patients with primary endpoint evaluated were included in this analysis.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Reproductive Health Program in Patients With Cancer	NCT01806129	Malignant Neopl...	Standard practi... Training module...	15 Years - 55 Years	Eastern Cooperative Oncology Group
Reproductive Health Program in Patients With Cancer	NCT01806129	Malignant Neopl...	Standard practi... Training module...	15 Years - 55 Years	Eastern Cooperative Oncology Group

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