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NCT04678414 Clinical Trial

Infertility Survey Among Reproductive Age Women With Gynecological and Breast Cancer

Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial

Official title:
Infertility Survey Among Reproductive Age Women With Gynecological and Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04678414
Other study ID # 2018-0477
Secondary ID NCI-2020-0829520
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2019
Est. completion date February 2, 2027

Study information
Verified date February 2024
Source M.D. Anderson Cancer Center
Contact Jose A Rauh-Hain
Phone 713-794-1759
Email jarauh@mdanderson.org
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1410
Est. completion date February 2, 2027
Est. primary completion date February 2, 2027
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

  • 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
  • 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
  • Breast Neoplasms
  • Carcinoma, Ovarian Epithelial
  • Endometrial Carcinoma
  • Endometrial Neoplasms
  • Female Reproductive System Disorder
  • Infertility
  • 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
  • Uterine Cervical Neoplasms

Intervention

Behavioral:
• Healthcare Activity
Attend focus group
Other:
• Survey Administration
Complete survey

Locations
Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Up to 3 years
Primary Known-group validity Will use t-test to compare two groups. If the distributional assumptions are not met, will use the Mann Whitney test. Up to 3 years
Primary 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. Up to 3 years
Primary 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. Up to 3 years
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