Trial Outcomes & Findings for Reproductive Health Program in Patients With Cancer (NCT NCT01806129)

Last Updated: 2025-06-13

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

Target enrollment

434 participants

Primary outcome timeframe

At baseline and 3 months

Results posted on

2025-06-13

Participant Flow

This study was activated on September 30, 2015 for site start-up preparation, opened to accrual on July 14, 2016, accrued its first patient on September 2, 2016, and closed to accrual on April 28, 2021 with a total of 434 patients accrued by 17 NCI Community Oncology Research Program (NCORP) sites.

Participant milestones

Participant milestones
Measure	Arm A (no Intervention) Patients undergo usual standard practice related to reproductive health.	Arm B (Reproductive Health Program) Training modules, algorithm, referral development: Patients undergo reproductive health program comprising didactics, reproductive health assessment and navigating algorithm, and network development.
Overall Study STARTED	278	156
Overall Study Eligible and Analyzable Patients	269	151
Overall Study COMPLETED	278	156
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reproductive Health Program in Patients With Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A (no Intervention) n=269 Participants Patients undergo usual standard practice related to reproductive health.	Arm B (Reproductive Health Program) n=151 Participants Training modules, algorithm, referral development: Patients undergo reproductive health program comprising didactics, reproductive health assessment and navigating algorithm, and network development.	Total n=420 Participants Total of all reporting groups
Age, Continuous	41 years n=93 Participants	39 years n=4 Participants	41 years n=27 Participants
Sex: Female, Male Female	269 Participants n=93 Participants	151 Participants n=4 Participants	420 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	27 Participants n=93 Participants	40 Participants n=4 Participants	67 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	229 Participants n=93 Participants	108 Participants n=4 Participants	337 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	13 Participants n=93 Participants	3 Participants n=4 Participants	16 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	24 Participants n=93 Participants	5 Participants n=4 Participants	29 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	7 Participants n=93 Participants	1 Participants n=4 Participants	8 Participants n=27 Participants
Race (NIH/OMB) Black or African American	56 Participants n=93 Participants	26 Participants n=4 Participants	82 Participants n=27 Participants
Race (NIH/OMB) White	148 Participants n=93 Participants	114 Participants n=4 Participants	262 Participants n=27 Participants
Race (NIH/OMB) More than one race	3 Participants n=93 Participants	0 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	31 Participants n=93 Participants	4 Participants n=4 Participants	35 Participants n=27 Participants

PRIMARY outcome

Timeframe: At baseline and 3 months

Population: Only eligible patients who were evaluable for the primary endpoint were included in the analysis.

Outcome measures

Outcome measures
Measure	Arm A (no Intervention) n=245 Participants Patients undergo usual standard practice related to reproductive health.	Arm B (Reproductive Health Program) n=134 Participants Training modules, algorithm, referral development: Patients undergo reproductive health program comprising didactics, reproductive health assessment and navigating algorithm, and network development.
Proportion of Patients With Appropriate Reproductive Health Management Without appropriate reproductive health management	129 Participants	46 Participants
Proportion of Patients With Appropriate Reproductive Health Management With appropriate reproductive health management	116 Participants	88 Participants

SECONDARY outcome

Timeframe: At baseline

Population: Patients with both patient rating and physician rating available were included in this analysis.

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.

Outcome measures

Outcome measures
Measure	Arm A (no Intervention) n=260 Participants Patients undergo usual standard practice related to reproductive health.	Arm B (Reproductive Health Program) n=145 Participants Training modules, algorithm, referral development: Patients undergo reproductive health program comprising didactics, reproductive health assessment and navigating algorithm, and network development.
Difference in Rating Between Patients and Their Clinicians in Importance of Fertility Maintenance	0.03 score on a scale Standard Deviation 0.67	0.12 score on a scale Standard Deviation 0.67

SECONDARY outcome

Timeframe: Baseline and 3 months

Population: All eligible/analyzable patients were included in the analysis.

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

Outcome measures

Outcome measures
Measure	Arm A (no Intervention) n=269 Participants Patients undergo usual standard practice related to reproductive health.	Arm B (Reproductive Health Program) n=151 Participants Training modules, algorithm, referral development: Patients undergo reproductive health program comprising didactics, reproductive health assessment and navigating algorithm, and network development.
The Changes in Reproductive Health Status From Baseline to 3 Months Baseline · Sextually active & childbearing not completed at 3 months	52 Participants	34 Participants
The Changes in Reproductive Health Status From Baseline to 3 Months Baseline · Sextually active & childbearing completed at 3 months	109 Participants	58 Participants
The Changes in Reproductive Health Status From Baseline to 3 Months Baseline · Sextually not active & childbearing not completed at 3 months	32 Participants	20 Participants
The Changes in Reproductive Health Status From Baseline to 3 Months Baseline · Sextually not active & childbearing completed at 3 months	62 Participants	35 Participants
The Changes in Reproductive Health Status From Baseline to 3 Months Baseline · Sexuality unknown & childbearing not completed at 3 months	2 Participants	0 Participants
The Changes in Reproductive Health Status From Baseline to 3 Months Baseline · Sexuality unknown & childbearing completed at 3 months	3 Participants	0 Participants
The Changes in Reproductive Health Status From Baseline to 3 Months Baseline · Pregnant/Pregnancy in 1 year at 3 months	9 Participants	4 Participants
The Changes in Reproductive Health Status From Baseline to 3 Months Baseline · Missing/Unknown at 3 months	0 Participants	0 Participants
The Changes in Reproductive Health Status From Baseline to 3 Months 3 months · Sextually active & childbearing not completed at 3 months	37 Participants	14 Participants
The Changes in Reproductive Health Status From Baseline to 3 Months 3 months · Sextually active & childbearing completed at 3 months	88 Participants	45 Participants
The Changes in Reproductive Health Status From Baseline to 3 Months 3 months · Sextually not active & childbearing not completed at 3 months	20 Participants	10 Participants
The Changes in Reproductive Health Status From Baseline to 3 Months 3 months · Sextually not active & childbearing completed at 3 months	71 Participants	37 Participants
The Changes in Reproductive Health Status From Baseline to 3 Months 3 months · Sexuality unknown & childbearing not completed at 3 months	0 Participants	0 Participants
The Changes in Reproductive Health Status From Baseline to 3 Months 3 months · Sexuality unknown & childbearing completed at 3 months	2 Participants	2 Participants
The Changes in Reproductive Health Status From Baseline to 3 Months 3 months · Pregnant/Pregnancy in 1 year at 3 months	18 Participants	15 Participants
The Changes in Reproductive Health Status From Baseline to 3 Months 3 months · Missing/Unknown at 3 months	33 Participants	28 Participants

SECONDARY outcome

Timeframe: Baseline and 3 months

Population: Eligible patients with primary endpoint evaluated were included in this analysis.

Outcome measures

Outcome measures
Measure	Arm A (no Intervention) n=245 Participants Patients undergo usual standard practice related to reproductive health.	Arm B (Reproductive Health Program) n=134 Participants Training modules, algorithm, referral development: Patients undergo reproductive health program comprising didactics, reproductive health assessment and navigating algorithm, and network development.
Associations Between Clinical and Demographic Factors and Adequacy of Reproductive Health Care Management Completed childbearing at baseline · With appropriate reproductive health management	79 Participants	62 Participants
Associations Between Clinical and Demographic Factors and Adequacy of Reproductive Health Care Management Completed childbearing at baseline · Without appropriate reproductive health management	80 Participants	21 Participants
Associations Between Clinical and Demographic Factors and Adequacy of Reproductive Health Care Management Childbearing not completed at baseline · With appropriate reproductive health management	37 Participants	26 Participants
Associations Between Clinical and Demographic Factors and Adequacy of Reproductive Health Care Management Childbearing not completed at baseline · Without appropriate reproductive health management	49 Participants	25 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Arm A (no Intervention)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 10 deaths

Arm B (Reproductive Health Program)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 7 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Study Statistician

ECOG-ACRIN Statistical Office

Phone: 617-632-3012

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60