NCT04678414

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,410

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Apr 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Apr 2019Feb 2027

Study Start

First participant enrolled

April 1, 2019

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 22, 2020

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2027

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

7.8 years

First QC Date

December 16, 2020

Last Update Submit

April 10, 2026

Conditions

Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage IA Breast Cancer AJCC v8Anatomic Stage IB Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage IIA Breast Cancer AJCC v8Anatomic Stage IIB Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IIIA Breast Cancer AJCC v8Anatomic Stage IIIB Breast Cancer AJCC v8Anatomic Stage IIIC Breast Cancer AJCC v8Endometrial CarcinomaFemale Reproductive System DisorderPrognostic Stage I Breast Cancer AJCC v8Prognostic Stage IA Breast Cancer AJCC v8Prognostic Stage IB Breast Cancer AJCC v8Prognostic Stage II Breast Cancer AJCC v8Prognostic Stage IIA Breast Cancer AJCC v8Prognostic Stage IIB Breast Cancer AJCC v8Prognostic Stage III Breast Cancer AJCC v8Prognostic Stage IIIA Breast Cancer AJCC v8Prognostic Stage IIIB Breast Cancer AJCC v8Prognostic Stage IIIC Breast Cancer AJCC v8Stage I Uterine Corpus Cancer AJCC v8Stage IA Cervical Cancer AJCC v8Stage IA Ovarian Cancer AJCC v8Stage IA Uterine Corpus Cancer AJCC v8Stage IA1 Cervical Cancer AJCC v8Stage IA2 Cervical Cancer AJCC v8Stage IB1 Cervical Cancer AJCC v8Stage IC Ovarian Cancer AJCC v8

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

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 ActivityOther: Survey Administration

Interventions

Healthcare ActivityBEHAVIORAL

Attend focus group

Also known as: Health Care Activity, Healthcare
Observational (focus group, survey)
Survey AdministrationOTHER

Complete survey

Observational (focus group, survey)

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Endometrial NeoplasmsUterine Cervical NeoplasmsOvarian Neoplasms

Interventions

Delivery of Health Care

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesUterine Cervical DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Patient Care ManagementHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Jose A Rauh-Hain

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2020

First Posted

December 22, 2020

Study Start

April 1, 2019

Primary Completion (Estimated)

February 2, 2027

Study Completion (Estimated)

February 2, 2027

Last Updated

April 15, 2026

Record last verified: 2026-04

Locations

US(1)