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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

434

participants targeted

Target at P75+ for not_applicable

Timeline

7mo left

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach

1 country

109 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

10.3 years study duration

Study Progress95%

Sep 2016Dec 2026

First Submitted

Initial submission to the registry

February 19, 2013

Completed

16 days until next milestone

First Posted

Study publicly available on registry

March 7, 2013

Completed

3.5 years until next milestone

Study Start

First participant enrolled

September 2, 2016

Completed

4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

October 5, 2022

Completed

4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Expected

Last Updated

June 3, 2026

Status Verified

May 1, 2026

Enrollment Period

4.9 years

First QC Date

February 19, 2013

Results QC Date

September 8, 2022

Last Update Submit

May 8, 2026

Conditions

Malignant Neoplasm

Keywords

reproductive health

Outcome Measures

Primary Outcomes (1)

Proportion of Patients With Appropriate Reproductive Health Management
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.
At baseline and 3 months

Secondary Outcomes (3)

Difference in Rating Between Patients and Their Clinicians in Importance of Fertility Maintenance
At baseline
The Changes in Reproductive Health Status From Baseline to 3 Months
Baseline and 3 months
Associations Between Clinical and Demographic Factors and Adequacy of Reproductive Health Care Management
Baseline and 3 months

Other Outcomes (2)

Levels of Endocrine Markers of Fertility
Baseline and 3, 6, 12, 24 months
Sexual Function Score by Patient-Reported Outcomes Measurement Information System (PROMIS)
Baseline and 3, 6, 12, 24 months

Study Arms (2)

Arm A (no intervention)

ACTIVE COMPARATOR

Patients undergo usual standard practice related to reproductive health.

Other: Standard practice related to reproductive heath

Arm B (reproductive health program)

EXPERIMENTAL

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

Other: Training modules, algorithm, referral development

Interventions

Standard practice related to reproductive heathOTHER

Patients undergo usual standard practice related to reproductive health.

Arm A (no intervention)

Training modules, algorithm, referral developmentOTHER

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

Arm B (reproductive health program)

Eligibility Criteria

Age15 Years - 55 Years

Sexfemale

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

ECOG-ACRIN Cancer Research Grouplead
National Cancer Institute (NCI)collaborator

Study Sites (109)

Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, 72401, United States

Location

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, 80012, United States

Location

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, 80304, United States

Location

Cancer Center of Colorado at Sloan's Lake

Denver, Colorado, 80204, United States

Location

Rocky Mountain Cancer Centers-Sky Ridge

Lone Tree, Colorado, 80124, United States

Location

SCL Health Lutheran Medical Center

Wheat Ridge, Colorado, 80033, United States

Location

Augusta University Medical Center

Augusta, Georgia, 30912, United States

Location

John B Amos Cancer Center

Columbus, Georgia, 31904, United States

Location

Hawaii Cancer Care Inc-POB II