Infertility Survey Among Reproductive Age Women With Gynecological and Breast Cancer

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Prognostic Stage IA Breast Cancer AJCC v8; Prognostic Stage IB Breast Cancer AJCC v8; Prognostic Stage I Breast Cancer AJCC v8; Stage IA2 Cervical Cancer AJCC v8; Stage IA Cervical Cancer AJCC v8; Prognostic Stage IIB Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Prognostic Stage III Breast Cancer AJCC v8; Female Reproductive System Disorder; Prognostic Stage IIIA Breast Cancer AJCC v8; Endometrial Carcinoma; Stage IB1 Cervical Cancer AJCC v8; Stage IA Uterine Corpus Cancer AJCC v8; Stage IA Ovarian Cancer AJCC v8; Prognostic Stage II Breast Cancer AJCC v8; Anatomic Stage IA Breast Cancer AJCC v8; Stage IA1 Cervical Cancer AJCC v8; Prognostic Stage IIA Breast Cancer AJCC v8; Stage IC Ovarian Cancer AJCC v8; Prognostic Stage IIIC Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIB Breast Cancer AJCC v8; Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage IIIB Breast Cancer AJCC v8; Anatomic Stage IIIB Breast Cancer AJCC v8; Anatomic Stage IIIC Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IB Breast Cancer AJCC v8; Stage I Uterine Corpus Cancer AJCC v8

Treatments: Other: Survey Administration; Behavioral: Healthcare Activity

Study type: Observational

Funder types: Other

Identifiers

NCT04678414

2018-0477 (Other Identifier)

NCI-2020-08295 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,410 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,410 participants in 1 patient group

Observational (focus group, survey)

Description:

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.

Treatment:

Behavioral: Healthcare Activity

Other: Survey Administration