Reproductive Health Program in Patients With Cancer
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
Other: educational intervention
Other: questionnaire administration
Procedure: quality-of-life assessment
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||EROS: Engendering Reproductive Health Within Oncologic Survivorship|
- Adoption of appropriate reproductive health management consistent with initial reproductive health goals of the patient based on success of the EROS Trial Algorithm as a tool [ Time Frame: Within 3 months of enrollment ] [ Designated as safety issue: No ]The consistency rate of reproductive health management at each time point will be summarized, by arm, with frequency and percentage along with its 95% confidence interval.
- Patient-reported initiation or continuation of long-term contraception (LTC) based on patient report from patient follow-up interview [ Time Frame: Within 6 months of enrollment into the study ] [ Designated as safety issue: No ]The LTC usage rate at each time point will be reported with frequency and percentage along with its 95% confidence interval.
- Ongoing usage rate of LTC at longitudinal assessments [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Rates and compliance of short-term contraception (STC) usage [ Time Frame: By the end of 5 years after registration in the study ] [ Designated as safety issue: No ]
- Proportion of patients with desired pregnancy [ Time Frame: By the end of 5 years after registration in the study ] [ Designated as safety issue: No ]
- PROMIS Survey Instrument score obtained by the Sexual Function Survey in the study subjects [ Time Frame: Over the 5 year study period ] [ Designated as safety issue: No ]
|Study Start Date:||November 2013|
|Estimated Primary Completion Date:||November 2026 (Final data collection date for primary outcome measure)|
No Intervention: Arm A (no intervention)
Patients undergo usual standard practice related to reproductive health.
Experimental: Arm B (reproductive health program)
Patients undergo reproductive health program comprising didactics, reproductive health assessment and navigating algorithm, and network development.
Other: educational intervention
Undergo reproductive health program
Other Name: intervention, educationalOther: questionnaire administration
Ancillary studiesProcedure: quality-of-life assessment
Other Name: quality of life assessment
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 women (18-55) 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 5 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: Patients are randomized to 1 of 2 arms. 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 treatment, patients are followed up periodically.
|United States, Massachusetts|
|Eastern Cooperative Oncology Group||Not yet recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Ashlesha A. Patel 312-864-5935 email@example.com|
|Principal Investigator: Ashlesha A. Patel|
|Principal Investigator:||Ashlesha Patel||Eastern Cooperative Oncology Group|