婦人科および乳がんの生殖年齢の女性における不妊症調査
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.
調査の概要
状態
条件
- 解剖学的ステージ I 乳がん AJCC v8
- 解剖学的ステージ IA 乳がん AJCC v8
- 解剖学的ステージ IB 乳がん AJCC v8
- 解剖学的ステージ II 乳がん AJCC v8
- 解剖学的病期 IIA 乳がん AJCC v8
- 解剖学的ステージ IIB 乳がん AJCC v8
- 解剖学的ステージ III 乳がん AJCC v8
- 解剖学的病期 IIIA 乳がん AJCC v8
- 解剖学的病期 IIIB 乳がん AJCC v8
- 解剖学的病期 IIIC 乳がん AJCC v8
- 予後I期乳がんAJCC v8
- 予後 IA期乳がん AJCC v8
- 予後 IB期乳がん AJCC v8
- 予後 II期乳がん AJCC v8
- 予後 ステージ IIA 乳がん AJCC v8
- 予後 ステージ IIB 乳がん AJCC v8
- 予後 III期乳がん AJCC v8
- 予後 IIIA期乳がん AJCC v8
- 予後 IIIB期乳がん AJCC v8
- 予後 IIIC期乳がん AJCC v8
- 子宮内膜がん
- ステージ IA 子宮頸がん AJCC v8
- ステージ IA1 子宮頸がん AJCC v8
- ステージ IA2 子宮頸がん AJCC v8
- ステージ IB1 子宮頸がん AJCC v8
- I期子宮体がんAJCC v8
- ステージ IA 子宮体がん AJCC v8
- ステージ IA 卵巣がん AJCC v8
- IC期の卵巣がんAJCC v8
- 女性生殖器系障害
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究場所
-
-
Texas
-
Houston、Texas、アメリカ、77030
- M D Anderson Cancer Center
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Women seen at the MD Anderson Oncofertility Clinic and Adolescent and Young Adult Program or women in the California Cancer Registry
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：CROSS_SECTIONAL
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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. |
Complete survey Attend focus group
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Underlying constructs
時間枠：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. |
Up to 3 years
|
|
Known-group validity
時間枠：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. |
Up to 3 years
|
|
Convergent validity
時間枠：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. |
Up to 3 years
|
|
Live birth
時間枠：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. |
Up to 3 years
|
協力者と研究者
捜査官
- 主任研究者：Jose A Rauh-Hain、M.D. Anderson Cancer Center
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2018-0477
- 2018-0477 (その他の識別子：M D Anderson Cancer Center)
- NCI-2020-08295 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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