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Reproductive Health Program in Patients With Cancer (EROS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01806129
Recruitment Status : Active, not recruiting
First Posted : March 7, 2013
Results First Posted : October 5, 2022
Last Update Posted : October 13, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )

Brief Summary:
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 or disease Intervention/treatment Phase
Malignant Neoplasm Other: Standard practice related to reproductive heath Other: Training modules, algorithm, referral development Not Applicable

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 434 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: EROS: Engendering Reproductive Health Within Oncologic Survivorship
Actual Study Start Date : July 14, 2016
Actual Primary Completion Date : July 31, 2021
Estimated Study Completion Date : April 30, 2023

Arm Intervention/treatment
Active Comparator: Arm A (no intervention)
Patients undergo usual standard practice related to reproductive health.
Other: Standard practice related to reproductive heath
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: Training modules, algorithm, referral development
Patients undergo reproductive health program comprising didactics, reproductive health assessment and navigating algorithm, and network development.




Primary Outcome Measures :
  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 Outcome Measures :
  1. Consistency Rate Between Patients and Their Clinicians in Estimates of Significance of the Reproductive Health Goals for the Patient [ Time Frame: At baseline and 3, 6, 12, 24 months ]
    The ratings on the reproductive health value questions (each on a 1-10 scale) were assessed among patients and the corresponding treating physicians. The consistency rate between patients and their physicians is to be reported. Higher scores indicate more importance of the target reproductive health goal.

  2. The Distribution of the Usage of Contraceptive Methods [ Time Frame: Baseline and 3, 6, 12, 24 months ]
    The usage of contraceptive methods were evaluated at baseline, 3, 6, 12, and 24 months and the distribution over time is to be reported by arm.

  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
Show Show 109 study locations
Sponsors and Collaborators
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Ashlesha Patel Eastern Cooperative Oncology Group
  Study Documents (Full-Text)

Documents provided by Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group ):
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Responsible Party: ECOG-ACRIN Cancer Research Group
ClinicalTrials.gov Identifier: NCT01806129    
Other Study ID Numbers: E1Q11
NCI-2012-02869 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
U10CA037403 ( U.S. NIH Grant/Contract )
First Posted: March 7, 2013    Key Record Dates
Results First Posted: October 5, 2022
Last Update Posted: October 13, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group ):
reproductive health
Additional relevant MeSH terms:
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Neoplasms