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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-08295 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2018-0477 | Other Identifier | M D Anderson Cancer Center |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthcare Activity | Behavioral | Attend focus group |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Women seen at the MD Anderson Oncofertility Clinic and Adolescent and Young Adult Program or women in the California Cancer Registry
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| Name | Affiliation | Role |
|---|---|---|
| Jose A Rauh-Hain | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| Survey Administration | Other | Complete survey |
|
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D002577 | Uterine Cervical Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| ID | Term |
|---|---|
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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