NCT03817814

Brief Summary

This study will help the researchers learn more about factors that affect the decisions about fertility preservation and family building made by young women with breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
209

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 18, 2019

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 28, 2019

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2025

Completed
Last Updated

August 17, 2025

Status Verified

August 1, 2025

Enrollment Period

6.6 years

First QC Date

January 21, 2019

Last Update Submit

August 15, 2025

Conditions

Keywords

Quality of LifeWeb-based questionnaire18-461

Outcome Measures

Primary Outcomes (1)

  • Patient-reported outcome questionnaire - Fertility Preservation Questionnaire

    Number of patients reporting that fertility tools were recommended to them following their breast cancer diagnosis

    1 year

Study Arms (1)

Women with Breast Cancer

This is a cross-sectional survey of young women with breast cancer (YWBC) who received a consultation with an MSK Fertility Nurse Specialist before starting cancer treatment.

Behavioral: web-based questionnaire

Interventions

Participants will complete a web-based questionnaire examining the decisions patients made about fertility preservation before and after treatment, the factors that influenced their decisions, and the ways in which patients pursue family building after treatment.

Women with Breast Cancer

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen with Breast Cancer Regarding Fertility Preservation before Cancer Treatment.
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

This is a cross-sectional survey of YWBC who received a pre-treatment consultation with a FNS from 2009 through 2018. Participants will complete a one-time web-based questionnaire examining the decisions they made about FP before and after treatment, the factors that influenced FP decisions, and the ways in which patients pursue FB after treatment.

You may qualify if:

  • Breast cancer, Stage 0-III
  • Female
  • years of age at time of diagnosis
  • Patients that completed their primary breast cancer treatment (surgery, chemotherapy, radiation therapy). Patients can still be on endocrine therapy, trastuzumab and/or pertuzumab therapy.
  • Received education and counseling by MSK Fertility Nurse Specialist before beginning cancer treatment from 2009 through 2018

You may not qualify if:

  • Unable to read English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Shari Goldfarb, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2019

First Posted

January 28, 2019

Study Start

January 18, 2019

Primary Completion

August 11, 2025

Study Completion

August 11, 2025

Last Updated

August 17, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Shared Documents
SAP, ICF

Locations