Infertility Survey Among Reproductive Age Women With Gynecological and Breast Cancer
Study Details
Study Description
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:
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To tailor the National Fertility Barriers (NFB) Survey for women who have had gynecological and breast cancers.
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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:
- 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.
Study Design
Arms and Interventions
| Arm | 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:
Other: Survey Administration
Complete survey
|
Outcome Measures
Primary Outcome Measures
- Underlying constructs [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.
- Known-group validity [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.
- Convergent validity [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.
- Live birth [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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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
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TELEPHONE SURVEY: Women in the California Cancer Registry
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TELEPHONE SURVEY: Are 18-45 years old
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TELEPHONE SURVEY: Were diagnosed with early-stage ovarian (IA and IC), endometrial (IA), cervical (IA1-IB1), or breast cancer (I-III)
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TELEPHONE SURVEY: Are 5-12 years post diagnosis between the years of 2007-2014
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TELEPHONE SURVEY: Underwent fertility-preservation treatments
Exclusion Criteria:
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FOCUS GROUP: Do not speak English or Spanish
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SURVEY VALIDATION: Do not read and understand English
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TELEPHONE SURVEY: Do not speak English or Spanish
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | M D Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- M.D. Anderson Cancer Center
Investigators
- Principal Investigator: Jose A Rauh-Hain, M.D. Anderson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 2018-0477
- NCI-2020-08295
- 2018-0477