Fertility PreservationNCT03817814
Decisions of Young Women With Breast Cancer Regarding Fertility Preservation Before Cancer Treatment and Family Building After Treatment
An observational study of Fertility Preservation and Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Fertility Preservation, Breast Cancer
- What is being tested?
- web-based questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 209 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2019to 11 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- Breast cancer, Stage 0-III
- Female
- 18-45 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
Who cannot join
- Unable to read English
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
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.
- Conditions
- Fertility Preservation, Breast Cancer
- Being tested
- web-based questionnaire
- Keywords
- Quality of Life, Web-based questionnaire, 18-461
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
web-based questionnaireBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: web-based questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported outcome questionnaire - Fertility Preservation Questionnaire
Number of patients reporting that fertility tools were recommended to them following their breast cancer diagnosis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start18 Jan 2019
- Primary completion11 Aug 2025
- Study completion11 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility PreservationStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shari Goldfarb, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817814
- Sponsor's protocol ID
- 18-461
- Status last verified
- Aug 2025
- First submitted
- 21 Jan 2019
- Last updated
- 17 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decisions of Young Women With Breast Cancer Regarding Fertility Preservation Before Cancer Treatment and Family Building After Treatment
- ClinicalTrials.gov ID
- NCT03817814
- Acronym / sponsor ID
- 18-461
- Conditions
- Fertility Preservation, Breast Cancer
- Keywords
- Quality of Life, Web-based questionnaire, 18-461
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 18 Jan 2019 (actual)
- Primary completion
- 11 Aug 2025 (actual)
- Study completion
- 11 Aug 2025 (actual)
- First posted
- 28 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with Breast Cancer | – | Behavioral: web-based questionnaireThis 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- Breast cancer, Stage 0-III
- Female
- 18-45 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
Key exclusion criteria (1 listed)
- Unable to read English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| web-based questionnaireParticipants 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. | Behavioural | Women with Breast Cancer |
Primary outcome
Patient-reported outcome questionnaire - Fertility Preservation Questionnaire
Time frame: 1 year
Number of patients reporting that fertility tools were recommended to them following their breast cancer diagnosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shari Goldfarb, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fertility Preservation and Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported outcome questionnaire - Fertility Preservation Questionnaire (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.