Psychosocial Outcomes and Contralateral Prophylactic Mastectomy (CPM)
Treatment Decisions and Breast Cancer: Psychosocial Outcomes
調査の概要
詳細な説明
With your verbal permission, you may have been asked to complete a questionnaire about your surgical treatment preferences for breast cancer as part of initial screening for this study. This takes about 5 minutes to complete.
If you agree to participate in this study, during the same visit you will complete a questionnaire about your background, such as your education level, marital status, and family history of cancer. This should take about 3 minutes to complete.
You will also be asked to complete a questionnaire about your surgery decisions and your feelings about those decisions at the following times: around the time you enroll in study before your surgery, and again about 1, 6, and 12 months after the surgery is completed. This questionnaire should take about 30-40 minutes to complete each time. You may complete this questionnaire at the clinic or you may complete it at home. If you chose to complete the questionnaire at home, you will be given a postage-paid envelope to mail it back to the study staff.
Length of Study:
After you complete all of the questionnaires, your participation in this study will be over.
This is an investigational study.
A total of up to 345 participants will be enrolled in this study. Up to 245 will take part at MD Anderson and up to 100 will take part at Kelsey-Seybold.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Texas
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Houston、Texas、アメリカ、77030
- University of Texas MD Anderson Cancer Center
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Houston、Texas、アメリカ、77030
- Kelsey-Seybold
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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
説明
Inclusion Criteria:
- Newly diagnosed ductal carcinoma in situ (DCIS) or Stage I-III sporadic unilateral invasive breast cancer
- Age 18 or older
- Able to speak, read, and write English.
- Spouse/Partner: Married or living with patient for a year or more
- Spouse/Partner: Age 18 or older
- Spouse/Partner: Able to speak, read, and write English
Exclusion Criteria:
- Patients with previous breast cancer
- Prior history of prophylactic mastectomy
- Known to have a germline gene mutation that predisposes them to an increased risk of breast cancer (e.g., BRCA1, BRCA2), and/or if they are considered at high risk for contralateral breast cancer on the basis of a strong family history of cancer
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
コホートと介入
グループ/コホート |
介入・治療 |
---|---|
Contralateral Prophylactic Mastectomy (CPM) Group
Group of women who decide to have contralateral prophylactic mastectomy (CPM) along with scheduled mastectomy.
Screening questionnaire completed at baseline.
Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, and 12 months after the surgery is completed.
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Screening questionnaire completed at baseline.
Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, 12, and 18 months after the surgery is completed.
他の名前:
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No Contralateral Prophylactic Mastectomy (CPM) Group
Group of women who decide not to have contralateral prophylactic mastectomy (CPM) performed during scheduled mastectomy.
Screening questionnaire completed at baseline.
Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, and 12 months after unilateral mastectomy or breast conserving surgery is completed.
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Screening questionnaire completed at baseline.
Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, 12, and 18 months after the surgery is completed.
他の名前:
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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 |
---|---|---|
Psychosocial Outcomes of CPM Versus no CPM: Cancer Distress Score
時間枠:Baseline to 12 months post surgery, up to 18 months. Survey administered at 1, 6, 12 months following surgery.
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Cancer-specific distress was measured with the Impact of Events Scale (IES) to assess 2 common categories of responses to stressful events: intrusion and avoidance.
The IES scale consists of 15 items.
For the intrusion category (7 items), participants are asked to rate the items on a 4 point scale: 0 (not at all), 1 (rarely), 3 (sometimes), and 5 (often) and the sum is the total score (complete range is 0 to 35).
For the avoidance category (8 items), participants are asked to rate the items on a 4 point scale: 0 (not at all), 1 (rarely), 3 (sometimes), and 5 (often) and the sum is the total score (complete range 0 to 40).
The total cancer-specific distress score is the sum of the total intrusion score and the total avoidance score (complete range is 0 to 75).
The total distress score was averaged for surveys completed at each time point.
Higher mean scores indicate greater cancer-specific distress.
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Baseline to 12 months post surgery, up to 18 months. Survey administered at 1, 6, 12 months following surgery.
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Psychosocial Outcomes of CPM Versus no CPM: Satisfaction With Decision
時間枠:One to 12 months post surgery, up to 18 months. Survey administered at 1, 6, 12 months following surgery.
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The Satisfaction with Decision Scale (SWD) scale measures women's satisfaction with their surgery decision using the SWD six-item survey with a five-point scale where 1 is "strongly disagree" and 5 is "strongly agree" and the sum is the total score (complete range 6 to 30).
The total satisfaction with decision score was averaged for surveys completed at each time point.
Higher mean scores indicate greater satisfaction with the treatment decision.
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One to 12 months post surgery, up to 18 months. Survey administered at 1, 6, 12 months following surgery.
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協力者と研究者
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 (実際)
研究の完了 (実際)
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 (見積もり)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
乳がんの臨床試験
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Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital; The First Affiliated... と他の協力者完了
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