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NCT Number: NCT04678414

Infertility Survey Among Reproductive Age Women With Gynecological and Breast Cancer

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Anatomic Stage I Breast Cancer AJCC v8 Adnexal Diseases 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 Anatomic Stage III Breast Cancer AJCC v8 Anatomic Stage IIIA Breast Cancer AJCC v8 Anatomic Stage IIIB Breast Cancer AJCC v8 Anatomic Stage IIIC Breast Cancer AJCC v8 Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Carcinoma Endometrial Neoplasms Female Reproductive System Disorder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Prognostic Stage I Breast Cancer AJCC v8 Prognostic Stage IA Breast Cancer AJCC v8 Prognostic Stage IB Breast Cancer AJCC v8 Prognostic Stage II Breast Cancer AJCC v8 Prognostic Stage IIA Breast Cancer AJCC v8 Prognostic Stage IIB Breast Cancer AJCC v8 Prognostic Stage III Breast Cancer AJCC v8 Prognostic Stage IIIA Breast Cancer AJCC v8 Prognostic Stage IIIB Breast Cancer AJCC v8 Prognostic Stage IIIC Breast Cancer AJCC v8 Stage I Uterine Corpus Cancer AJCC v8 Stage IA Cervical Cancer AJCC v8 Stage IA Ovarian Cancer AJCC v8 Stage IA Uterine Corpus Cancer AJCC v8 Stage IA1 Cervical Cancer AJCC v8 Stage IA2 Cervical Cancer AJCC v8 Stage IB1 Cervical Cancer AJCC v8 Stage IC Ovarian Cancer AJCC v8 Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

PRIMARY OBJECTIVES:

I. 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:

I. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • FOCUS GROUP: Do not speak English or Spanish
  • SURVEY VALIDATION: Do not read and understand English
  • TELEPHONE SURVEY: Do not speak English or Spanish

Treatment and study plan

Healthcare Activity

Behavioral

Attend focus group

Other names: Health Care Activity, Healthcare

Survey Administration

Other

Complete survey

Primary outcomes

  1. Underlying constructs

    Time frame: Up to 3 years

    Will be measured by the Oncofertility Barriers Scale. Will perform factor analysis using principal axis factoring with oblique rotation to simplify the construct interpretation.

  2. Known-group validity

    Time frame: Up to 3 years

    Will use t-test to compare two groups. If the distributional assumptions are not met, will use the Mann Whitney test.

  3. Convergent validity

    Time frame: Up to 3 years

    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.

  4. Live birth

    Time frame: Up to 3 years

    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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Dec 22, 2020
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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