Clinical trial NCT04678414: Infertility Survey Among Reproductive Age Women With Gynecological and Breast Cancer
Official title: Infertility Survey Among Reproductive Age Women With Gynecological and Breast Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2020-12-22
Enrollment: 1410
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

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.

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.

Eligibility 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

Primary outcomes:
measure: Underlying constructs
timeFrame: Up to 3 years
measure: Known-group validity
timeFrame: Up to 3 years
measure: Convergent validity
timeFrame: Up to 3 years
measure: Live birth
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jose A Rauh-Hain
role: PRINCIPAL_INVESTIGATOR
References: