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Reproductive Health Program for Cancer Patients (EROS Trial)

N/A
Waitlist Available
Led By Ashlesha Patel
Research Sponsored by Eastern Cooperative Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients not currently on hormonal contraception with the presence of menses in the past 6 months
Pre-menopausal patients within the reproductive age range of 15-55 years
Must not have
Prior hysterectomy, bilateral oophorectomy or sterilization of any method
Patients who have initiated chemotherapy, radiation therapy or endocrine therapy prior to registration to this study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 3, 6, 12, 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at a program to help cancer patients understand and manage their fertility risks.

Who is the study for?
This trial is for pre-menopausal women aged 15-55 with a new cancer diagnosis, including those pregnant or with DCIS. Eligible participants must have cognitive ability to engage in the study and meet specific hormonal criteria. Women who've started chemo, radiation, endocrine therapy, or had certain sterilizing surgeries can't join.
What is being tested?
The study evaluates a reproductive health program designed to help female cancer patients understand and manage reproductive risks while pursuing their fertility goals. It includes standard practices plus training modules and referral development tailored to each patient's needs.
What are the potential side effects?
Since this trial involves educational programs rather than medical treatments, there are no direct side effects related to drugs or procedures. However, learning about fertility options may cause emotional or psychological impact.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not on birth control and have had a period in the last 6 months.
Select...
I am a pre-menopausal woman aged between 15 and 55.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had a hysterectomy, my ovaries removed, or been sterilized.
Select...
I have started chemotherapy, radiation, or hormone therapy before enrolling in this study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 3, 6, 12, 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 3, 6, 12, 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of Patients With Appropriate Reproductive Health Management
Secondary study objectives
Associations Between Clinical and Demographic Factors and Adequacy of Reproductive Health Care Management
Difference in Rating Between Patients and Their Clinicians in Importance of Fertility Maintenance
The Changes in Reproductive Health Status From Baseline to 3 Months
Other study objectives
Levels of Endocrine Markers of Fertility
Sexual Function Score by Patient-Reported Outcomes Measurement Information System (PROMIS)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B (reproductive health program)Experimental Treatment1 Intervention
Patients undergo reproductive health program comprising didactics, reproductive health assessment and navigating algorithm, and network development.
Group II: Arm A (no intervention)Active Control1 Intervention
Patients undergo usual standard practice related to reproductive health.

Find a Location

Who is running the clinical trial?

Eastern Cooperative Oncology GroupLead Sponsor
269 Previous Clinical Trials
151,455 Total Patients Enrolled
ECOG-ACRIN Cancer Research GroupLead Sponsor
121 Previous Clinical Trials
179,763 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,111,653 Total Patients Enrolled
Ashlesha PatelPrincipal InvestigatorEastern Cooperative Oncology Group

Media Library

Arm B (reproductive health program) Clinical Trial Eligibility Overview. Trial Name: NCT01806129 — N/A
Cancer Research Study Groups: Arm B (reproductive health program), Arm A (no intervention)
Cancer Clinical Trial 2023: Arm B (reproductive health program) Highlights & Side Effects. Trial Name: NCT01806129 — N/A
Arm B (reproductive health program) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01806129 — N/A
~47 spots leftby Dec 2025
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