Reproductive Health Program in Patients With Cancer
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|ClinicalTrials.gov Identifier: NCT01806129|
Recruitment Status : Recruiting
First Posted : March 7, 2013
Last Update Posted : August 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Malignant Neoplasm||Other: educational intervention Other: questionnaire administration Procedure: quality-of-life assessment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||612 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||EROS: Engendering Reproductive Health Within Oncologic Survivorship|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||November 2026|
|Estimated Study Completion Date :||November 2030|
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, educational
Other: questionnaire administration
Procedure: quality-of-life assessment
Other Name: quality of life assessment
- 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 ]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 ]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 ]
- Rates and compliance of short-term contraception (STC) usage [ Time Frame: By the end of 5 years after registration in the study ]
- Proportion of patients with desired pregnancy [ Time Frame: By the end of 5 years after registration in the study ]
- PROMIS Survey Instrument score obtained by the Sexual Function Survey in the study subjects [ Time Frame: Over the 5 year study period ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01806129
|United States, Massachusetts|
|Eastern Cooperative Oncology Group||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|