Cluster Randomized Trial Comparing Interventions to Enhance Genetic Counseling Among Breast Cancer Patients (SCUSF 1102)
A Cluster Randomized Controlled Trial Comparing Interventions to Enhance Utilization of Genetics Services Among Breast Cancer Patients
RATIONALE: Multi-faceted provider education and decision support intervention will increase the rate of appropriate referral of breast cancer patients at increased risk for hereditary breast and ovarian cancer (HBOC) to genetic counseling.
PURPOSE: This cluster randomized controlled trial will compare active and passive interventions to increase the rate of appropriate genetic counseling referrals of newly diagnosed breast cancer patients at increased risk for HBOC to genetic counseling in the community oncology setting.
調査の概要
詳細な説明
Approximately 5-10% of all breast cancer patients have hereditary breast cancer, the majority due to an inherited mutation in the BRCA1 or BRCA2 genes (BRCA mutation carriers). Breast cancer patients who are BRCA mutation carriers have up to a 65% risk for a new primary breast cancer in the future. Additionally, BRCA mutation carriers have a 10-45% lifetime risk for ovarian cancer.
Effective options to decrease these high future cancer risks are available to breast cancer patients who learn they carry a BRCA mutation - including prophylactic mastectomy and oophorectomy. Prophylactic mastectomy and oophorectomy reduce the risks for future primary breast cancer and ovarian cancer, respectively, by more than 90%. Because of the high risks for future cancer and the opportunity for effective risk reduction among mutation carriers, national guidelines consistently recommend referral of breast cancer patients at increased risk for hereditary breast cancer and ovarian cancer (HBOC) to genetic counseling by a qualified genetics professional. Lack of implementation of this standard of care constitutes an error of omission and jeopardizes patient outcomes.
We propose a cluster randomized controlled trial to compare a "passive intervention" - dissemination of professional guidelines - with an "active intervention" - a multi-faceted provider education and decision support intervention to improve 1) appropriate referral of breast cancer patients at risk for HBOC to genetic counseling in the community cancer center setting and 2) pre-surgical referral among newly diagnosed patients. Ultimately, these results will lead to decreased breast and ovarian cancer incidence and mortality among breast cancer patients and their family members, as well as improved outcomes of and satisfaction with surgical decision-making.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Florida
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Tampa、Florida、アメリカ、33612
- SunCoast CCOP Research Base
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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
説明
Participant Inclusion Criteria:
- Females 18 years of age or greater
- Newly diagnosed primary breast cancer prior to initial definitive surgical treatment, including In situ and Invasive cancer, Stages 0 - III. Pathologic confirmation of diagnosis is required.
- Able to read and write in English or Spanish
Participant Exclusion Criteria:
- Any previous diagnosis of cancer except for non-melanoma skin cancer
- Stage IV breast cancer
- Received HBOC genetic counseling or mutation testing prior to diagnosis. If the patient was previously tested only for a variant of uncertain clinical significance (i.e., not for known familial mutation, Jewish ethnicity panel/Multisite 3 or comprehensive sequencing) and documentation is provided, they remain eligible.
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
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Active Provider Intervention
Participating Sites assigned to the active intervention cluster will receive a multi-faceted provider education and decision support intervention to improve 1) appropriate referral of breast cancer patients at risk for HBOC to genetic counseling in the community cancer center setting and 2) pre-surgical referral among newly diagnosed patients.
They will also receive the National Comprehensive Cancer Network (NCCN) guidelines and Commission on Cancer definition of qualified genetics professional.
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Participating Sites assigned to the active intervention cluster will receive a multi-faceted provider education and decision support intervention to improve appropriate referral of breast cancer patients at risk for HBOC to genetic counseling and pre-surgical referral among newly diagnosed patients.
他の名前：
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介入なし：Passive Provider Intervention
Participating Sites assigned to the passive intervention cluster will only receive the National Comprehensive Cancer Network (NCCN) guidelines and Commission on Cancer definition of qualified genetics professional.
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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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Rate of appropriate referral of newly diagnosed breast cancer patients at increased risk for HBOC to genetic counseling in Active vs. Passive Intervention Clusters
時間枠：1 year post diagnosis
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Site providers will be randomized and receive either the active or passive genetic counseling intervention.
Post intervention, site providers will maintain a database of all newly diagnosed breast cancer patients that meet the study eligibility criteria.
One year post diagnosis, subjects will be mailed an informed consent form including questionnaires from their providers.
Returned patient questionnaire data along with information provided directly from site providers will be utilized to determine the rate of appropriate referral for genetic counseling.
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1 year post diagnosis
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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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Rate of appropriate referral of newly diagnosed breast cancer patients at increased risk for HBOC to genetic counseling in Active vs. Passive Intervention Clusters
時間枠：12-15 months post diagnosis
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Secondary outcomes will be assessed by patient questionnaire and medical record documentation, where appropriate, and include evaluation of:
Psychosocial outcomes:
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12-15 months post diagnosis
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協力者と研究者
捜査官
- スタディチェア：Rebecca Sutphen, MD、University of South Florida
研究記録日
主要日程の研究
研究開始
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
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