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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01806129
|United States, Massachusetts|
|Eastern Cooperative Oncology Group||Not yet recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Ashlesha A. Patel 312-864-5935 firstname.lastname@example.org|
|Principal Investigator: Ashlesha A. Patel|
|Principal Investigator:||Ashlesha Patel||Eastern Cooperative Oncology Group|