Anatomic Stage I Breast Cancer AJCC v8NCT04678414
Infertility Survey Among Reproductive Age Women With Gynecological and Breast Cancer
An observational study of Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This study develops infertility survey among reproductive age women with gynecological and breast cancer. This study aims to learn how women consider whether or not to try to have a baby after surviving cancer. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8
- What is being tested?
- Healthcare Activity and Survey Administration
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,410 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 2 Feb 2027
- Phase
- Observational
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: Women seen at the MD Anderson Oncofertility Clinic and Adolescent and Young Adult Program or women in the California Cancer Registry
Who may be able to join
- FOCUS GROUP: Women seen at the MD Anderson Oncofertility Clinic and Adolescent and Young Adult Program who are 18-45 years old at the time of cancer diagnosis
- SURVEY VALIDATION: Women seen at the MD Anderson Oncofertility Clinic and Adolescent and Young Adult Program who are 18-45 years old at the time of cancer diagnosis
- TELEPHONE SURVEY: Women in the California Cancer Registry
- TELEPHONE SURVEY: Are 18-45 years old
- TELEPHONE SURVEY: Were diagnosed with early-stage ovarian (IA and IC), endometrial (IA), cervical (IA1-IB1), or breast cancer (I-III)
- TELEPHONE SURVEY: Are 5-12 years post diagnosis between the years of 2007-2014
- TELEPHONE SURVEY: Underwent fertility-preservation treatments
Who cannot join
- FOCUS GROUP: Do not speak English or Spanish
- SURVEY VALIDATION: Do not read and understand English
- TELEPHONE SURVEY: Do not speak English or Spanish
Trial locations and contacts
1 site in 1 country.
About this study
This study develops infertility survey among reproductive age women with gynecological and breast cancer. This study aims to learn how women consider whether or not to try to have a baby after surviving cancer. The advice gathered from this survey may be shared with patients and survivors in the future, so that they have information to inform their decisions about cancer treatment and family planning.
Read the detailed description
PRIMARY OBJECTIVES:
- To tailor the National Fertility Barriers (NFB) Survey for women who have had gynecological and breast cancers.
II. To administer the tailored survey and evaluate if utilization of infertility clinics and treatments is associated with pregnancies leading to live births after gynecological or breast cancer.
SECONDARY OBJECTIVE:
- To evaluate whether potential covariates are associated with utilization of infertility clinics and live births after gynecological and breast cancers (e.g. socio-demographic, clinical, psychological, lifestyle, and decision-making characteristics).
OUTLINE:
FOCUS GROUP: Patients attend an audiotaped focus group over 90 minutes to provide feedback for survey development.
SURVEY VALIDATION: Patients complete an online survey over 15-30 minutes at baseline and 2 days later.
TELEPHONE SURVEY: Patients complete a telephone survey.
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8
- Being tested
- Healthcare Activity, Survey Administration
- Medical subject headings
- Endometrial Neoplasms, Uterine Cervical Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthcare ActivityBehavioural
Also called Health Care Activity, Healthcare
Attend focus group
Survey AdministrationOther
Complete survey
| Study group | Role | What they receive |
|---|---|---|
| Observational (focus group, survey) | FOCUS GROUP: Patients attend an audiotaped focus group over 90 minutes to provide feedback for survey development.
SURVEY VALIDATION: Patients complete an online survey over 15-30 minutes at baseline and 2 days later.
TELEPHONE SURVEY: Patients complete a telephone survey. Receives: Behavioral: Healthcare Activity; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Underlying constructs
Will be measured by the Oncofertility Barriers Scale. Will perform factor analysis using principal axis factoring with oblique rotation to simplify the construct interpretation.
Measured: Up to 3 years
Known-group validity
Will use t-test to compare two groups. If the distributional assumptions are not met, will use the Mann Whitney test.
Measured: Up to 3 years
Convergent validity
Will correlate Oncofertility Barriers Scale scores with Evaluation and Nurturing Relationship Issues, Communication and Happiness scores. Analysis of variance will be used to generate a generalizability coefficient for relevant factors, as distributions allow. As distributions allow, will also assess a priori hypotheses that divergence will be observed among groups of women with different ages, cancer types, time since completing cancer treatment, and priori fertility concerns, as well as access to and utilization of fertility care. All tests will be two-sided and use a significance level of 0.05.
Measured: Up to 3 years
Live birth
Will compare cancer diagnosis, treatment characteristics and patient reported survey results by live birth (yes versus no) using a 2-sample t-test (or Wilcoxon depending on underlying distribution) and chi-squared test (or Fisher's exact test). Will also conduct logistic regression analysis regressing live birth on predictors of interest, and build a multivariable model based on univariate results including all terms significant at the 0.10 level then refining the model using backwards selection to include variables significant at the 0.05 level in the final model.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start1 Apr 2019
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by M.D. Anderson 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose A Rauh-Hain, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678414
- Sponsor's protocol ID
- 2018-0477
- Other IDs
- NCI-2020-08295, 2018-0477
- Status last verified
- Oct 2026
- First submitted
- 16 Dec 2020
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No