Impact of Individualized Radiotherapy Plan Review in Patients Receiving Adjuvant Radiotherapy for Breast Cancer
調査の概要
状態
条件
詳細な説明
This study will be a prospective study of women receiving adjuvant radiation therapy for management of breast cancer at the University of California Davis. All patients will be staged according to the American Joint Committee on Cancer Seventh edition. Primary disease treatment information including surgical approach and utilization of adjuvant chemotherapy will be evaluated.
All patients will have a validated quality of life assessment (FACIT-TS-PS) completed at three time points during their radiation therapy process. The patients will be randomized at the time of completion of radiation plan approval by the treating radiation oncologist in a one to one fashion to either proceed with standard education or more extensive plan review. The radiation oncology quality assurance (QA) process will be blinded to the randomization of the patient.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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California
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Sacramento、California、アメリカ、95817
- UC Davis Medical Center
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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
- Diagnosis of invasive breast cancer
- AJCC stage 1, 2, 3 breast carcinoma
- Patient deemed clinically appropriate for adjuvant breast or chest wall radiation following surgery
- Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during radiation therapy
- Patient must provide study specific informed consent prior to study entry
- Breast implants allowed
Exclusion Criteria
- Stage 4 breast cancer
- Ductal carcinoma in situ
- Patients treated with radiation for palliative intent
- Prior treatment with radiation therapy to the ipsilateral breast or chest wall
- Prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 5 years prior to study entry
- Prior invasive or in-situ carcinoma of the breast (-prior LCIS is eligible)
- Diagnosis of DCIS
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：ケースコントロール
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
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In-Depth Education
A. Standard radiotherapy discussion including rationale, number of fractions, side effects, +/- beam arrangements, potential and likely short and long-term toxicity, status checks, skin care, nursing and physician accessibility B. Radiotherapy plan review to include, but not limited to: beam arrangement, total dose, dose per fraction, target area(s), description of isodose lines, DVH review and discussion of prescription constraints for OARs
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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 |
|---|---|---|
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Satisfaction measure
時間枠：3 months
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Questions on the survey will be analyzed to see if patients are more satisfied with the in-depth education compared to the standard education.
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3 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Time measure
時間枠：3 Months
|
The amount of time in the clinic office will be analyzed for the in-depth education plan as compared to the standard education plan.
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3 Months
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Change in satisfaction over time
時間枠：3 months
|
Questions on the survey will be analyzed from baseline to the end of treatment to see if there are differences over time between the in-depth education group and the standard education group.
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3 months
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協力者と研究者
捜査官
- 主任研究者：Megan Daly, MD、UC Davis
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
本研究に関する用語
その他の研究ID番号
- 587842
- CCRO035 (その他の識別子：UC Davis)
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。