Reproductive Health Program in Patients With Cancer

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by Eastern Cooperative Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT01806129
First received: February 19, 2013
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention
Malignant Neoplasm
Other: educational intervention
Other: questionnaire administration
Procedure: quality-of-life assessment

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 612
Study Start Date: November 2013
Estimated Primary Completion Date: November 2026 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Ancillary studies
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Female patients presenting with initial diagnosis of any type of cancer (up to 3 months after diagnosis, and if applicable, before initiation of chemotherapy or radiation)

Pre-menopausal patients within the reproductive age range

Pregnant women are eligible to participate in this study

Patients must have the cognitive ability to participate in the study

Patients must not have had a prior hysterectomy, bilateral oophorectomy or sterilization of any method (including partner sterilization)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01806129

Locations
United States, Massachusetts
Eastern Cooperative Oncology Group Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Ashlesha A. Patel    312-864-5935    ashleshapatel16@yahoo.com   
Principal Investigator: Ashlesha A. Patel         
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Principal Investigator: Ashlesha Patel Eastern Cooperative Oncology Group
  More Information

No publications provided

Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT01806129     History of Changes
Other Study ID Numbers: E1Q11, NCI-2012-02869, U10CA037403
Study First Received: February 19, 2013
Last Updated: October 7, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 23, 2014