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Active, Not Recruiting

NCT Number: NCT01806129

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Malignant Neoplasm Neoplasms

Age range

15 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro, Jonesboro, Arkansas, United States

Loading trial locations.

About this study

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 females (15-55) 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 2-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: Participating institutions are randomized to 1 of 2 arms. Patients are assigned to a study arm depending on the institutional assignment.

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 intervention, patients are followed up periodically.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female patients presenting with initial diagnosis of any type of cancer, including patients with ductal carcinoma in situ (DCIS)
  • Pre-menopausal patients within the reproductive age range of 15-55 years; pre-menopausal is defined as females meeting the following criteria:
  • Patients not currently on hormonal contraception with the presence of menses in the past 6 months
  • If no menstruation in the past 6 months, without hormonal manipulation, then confirmed follicle-stimulating hormone (FSH) < 23mlU/mL
  • If age < 47 years and on hormonal contraception, then patient will be eligible regardless of menstrual history
  • If age ≥ 47 years and on hormonal contraception, then FSH confirmed < 23mIU/mL
  • Pregnant women are eligible to participate in this study
  • Patients must have the cognitive ability to participate in the study

Exclusion criteria

  • Patients who have initiated chemotherapy, radiation therapy or endocrine therapy prior to registration to this study
  • Prior hysterectomy, bilateral oophorectomy or sterilization of any method

Treatment and study plan

Standard practice related to reproductive heath

Other

Patients undergo usual standard practice related to reproductive health.

Training modules, algorithm, referral development

Other

Patients undergo reproductive health program comprising didactics, reproductive health assessment and navigating algorithm, and network development.

Primary outcomes

  1. Proportion of Patients With Appropriate Reproductive Health Management

    Time frame: At baseline and 3 months

    Appropriate reproductive health management was determined using the followings: (1) Females that were pregnant or interested in immediate pregnancy (defined as within 1 year of enrollment) were given referral to obstetrician/gynecologist or counseled about pregnancy options (2) Females interested in future childbearing were counseled or given a referral for fertility preservation if requested (3) Females who were not interested in immediate pregnancy were given a referral or counseling to select family planning that was consistent with plans for sexual activity and future childbearing. If a female fell into category 1, 2, or 3, and the appropriate referral occurred within 3 months of enrollment, then appropriate reproductive health management was achieved. For patients with appropriate reproductive health management in place before the baseline visit, they were included in the analysis and counted as having appropriate reproductive health management.

Secondary outcomes

  1. Difference in Rating Between Patients and Their Clinicians in Importance of Fertility Maintenance

    Time frame: At baseline

    The rating on the importance of fertility maintenance was assessed among patients and the corresponding treating physicians. The rating scale ranges between 1 and 10. Higher scores indicate more importance of fertility maintenance. The difference in rating was calculated by subtracting patient rating from physician's rating.

  2. The Changes in Reproductive Health Status From Baseline to 3 Months

    Time frame: Baseline and 3 months

    Patient's reproductive health choices relating to oncofertility, oncocontraception and pregnancy was assessed at baseline and 3 months. Patient's reproductive health status is categorized into the following categories:

    • Sextually active & childbearing not completed
    • Sextually active & childbearing completed
    • Sextually not active & childbearing not completed
    • Sextually not active & childbearing completed
    • Sexuality unknown & childbearing not completed
    • Sexuality unknown & childbearing completed
    • Pregnant/Pregnancy in 1 year
    • Missing/Unknown

  3. Associations Between Clinical and Demographic Factors and Adequacy of Reproductive Health Care Management

    Time frame: Baseline and 3 months

    Appropriate reproductive health management was determined using the followings: (1) Females that were pregnant or interested in immediate pregnancy (defined as within 1 year of enrollment) were given referral to obstetrician/gynecologist or counseled about pregnancy options (2) Females interested in future childbearing were counseled or given a referral for fertility preservation if requested (3) Females who were not interested in immediate pregnancy were given a referral or counseling to select family planning that was consistent with plans for sexual activity and future childbearing. If a female fell into category 1, 2, or 3, and the appropriate referral occurred within 3 months of enrollment, then appropriate reproductive health management was achieved. For patients with appropriate reproductive health management in place before the baseline visit, they were included in the analysis and counted as having appropriate reproductive health management.

Other outcomes

  1. Levels of Endocrine Markers of Fertility

    Time frame: Baseline and 3, 6, 12, 24 months

    Reproductive health-related biomarkers, including follicle-stimulating hormone (FSH), anti-müllerian hormone (AMH), thyroid stimulating hormone (TSH) and Thyroid peroxidase (TPO), were evaluated through blood samples collected at baseline and 3, 6, 12, 24 months.

  2. Sexual Function Score by Patient-Reported Outcomes Measurement Information System (PROMIS)

    Time frame: Baseline and 3, 6, 12, 24 months

    Sexual function was evaluated using PROMIS sexual function survey brief profile V1.0. All subdomain scores (except for the orgasm subdomain) are expressed as T-scores with a mean of 50 and a standard deviation of 10. A raw summed score is created for each domain. For Global Satisfaction with Sex Life, the raw summed score can range from 2 (endorsed "Not at all" to both items) to 10 (endorsed "Very" or "Very much" to both items). Higher scores indicate more satisfaction/interest/lubrication/discomfort/ability with sex life. Lower scores indicate less satisfaction/interest/lubrication/discomfort/ability with sex life.

Sponsors and collaborators

Lead sponsor

ECOG-ACRIN Cancer Research Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

EROS: Engendering Reproductive Health Within Oncologic Survivorship

Acronym: EROS

Important dates

Study start
2016
Primary completion
2021
Study completion
2026
First posted
Mar 7, 2013
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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