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Infertility Survey Among Reproductive Age Women With Gynecological and Breast Cancer

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ClinicalTrials.gov Identifier: NCT04678414
Recruitment Status : Recruiting
First Posted : December 22, 2020
Last Update Posted : December 22, 2020
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

Condition or disease Intervention/treatment
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 Endometrial Carcinoma Female Reproductive System Disorder 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 Behavioral: Healthcare Activity Other: Survey Administration

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 1410 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Infertility Survey Among Reproductive Age Women With Gynecological and Breast Cancer
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Group/Cohort Intervention/treatment
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.

Behavioral: Healthcare Activity
Attend focus group
Other Names:
  • Health Care Activity
  • Healthcare

Other: Survey Administration
Complete survey




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women seen at the MD Anderson Oncofertility Clinic and Adolescent and Young Adult Program or women in the California Cancer Registry
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04678414


Contacts
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Contact: Jose A Rauh-Hain 713-794-1759 jarauh@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Jose A. Rauh-Hain    713-794-1759    jarauh@mdanderson.org   
Principal Investigator: Jose A. Rauh-Hain         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Jose A Rauh-Hain M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04678414    
Other Study ID Numbers: 2018-0477
NCI-2020-08295 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0477 ( Other Identifier: M D Anderson Cancer Center )
First Posted: December 22, 2020    Key Record Dates
Last Update Posted: December 22, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Uterine Cervical Neoplasms
Endometrial Neoplasms
Infertility
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Uterine Neoplasms
Uterine Cervical Diseases
Uterine Diseases