ハイリスク前立腺がんの黒人患者における遺伝子検査の完了における教育的介入の利用
This is a pilot study to improve rates of germline genetic testing for black patients with aggressive prostate cancer as recommended by the updated guidelines by the National Cancer Comprehensive Network (NCCN) in 2018.
In this study, consented patients will undergo a low-risk intervention of an educational session with a trained staff member on germline testing in prostate cancer and, if agreeable, subsequent germline cancer genetic testing via a commercial lab test.
調査の概要
詳細な説明
This is a prospective, single-arm, quality improvement initiative for the use of a standardized educational intervention on germline testing in black patients with prostate cancer to improve the rates of germline genetic testing among those recommended for testing. Patients who consent to the study will undergo a one-on-one in-person education session regarding the rationale and the benefits/risks of germline testing.
The educational intervention will occur with a clinical research coordinator who will be trained to educate on germline testing in prostate cancer. At the start of the session, the patient will be given a short questionnaire to assess their understanding about germline and genetic testing, along with a Family History questionnaire.
Following the educational intervention, the patient will be asked to complete a short patient education and satisfaction questionnaire.
If a patient wishes to proceed with testing, they will sign the standard consent to proceed with germline testing via a commercial assay. Upon a patient deciding to pursue testing, testing will consist of a prostate cancer germline panel with a commercially available blood or saliva-based assay. Upon receipt of the results, the coordinator will alert the patient's clinician, who will then share the results with the patient either in clinic or by phone. If the results show a pathogenic germline mutation, the patient will be referred to see Henry Ford Health genetics clinic for consultation with a genetics counselor.
If a patient pursues genetic testing, following receipt of results, the patient's clinicians will be asked to complete a short survey on to assess how the results of germline testing affected the patient's current and future management.
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
-
-
Michigan
-
Detroit、Michigan、アメリカ、48202
- Henry Ford Cancer Pavilion
-
-
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
Inclusion Criteria:
-
Men, age greater than or equal to 18 years of age.
-
Men who racially identify as black or multiracial including black
-
Diagnosis of prostate cancer of any histology.
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Must meet NCCN guidelines for germline testing
-
Men with very low, low or intermediate risk prostate per NCCN guidelines with a positive family history or intraductal histology. Family history here is considered significant if the patient has:
- a first degree relative with prostate cancer or more than one first/second degree relative with prostate cancer, or
- ≥3 cancers on same side of family, especially diagnoses ≤50 years of age: bile duct, breast, colorectal, endometrial, gastric, kidney, melanoma, ovarian, pancreatic, prostate (but not clinically localized Grade Group 1), small bowel, or urothelial cancer
-
Men with high-risk, very-high risk (per NCCN definitions of risk groups), lymph node positive, or metastatic prostate cancer independent of family history of histology.
-
Exclusion Criteria:
- Have had prior germline testing.
- Have somatic genetic testing that is positive for a possible germline variant.
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：ヘルスサービス研究
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Educational intervention
Patients will be asked questions about genetic testing for prostate cancer before and after an educational intervention. |
The educational intervention will occur with a clinical research coordinator who will be trained to educate on germline testing in prostate cancer. |
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 |
|---|---|---|
|
Testing rate
時間枠：24 months
|
percentage of patients who undergo genetic testing after completing the education session |
24 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Baseline knowledge per "Patient Survey on Germline Testing in Prostate Cancer" questionnaire
時間枠：Day 1, before intervention
|
Pre-Intervention Patient Questionnaire: The pre-intervention patient questionnaire is a brief 16-item investigator-developed knowledge and attitude scale applicable to this population. It was developed through an expert panel to determine if participants are able to recall key core components about multigene panel testing and capture attitudes about genetic testing. This survey is estimated to take 10 minutes to complete. |
Day 1, before intervention
|
|
Post-intervention knowledge per "Patient Post-Education Patient Survey" questionnaire
時間枠：Day 1, after intervention
|
Post-Intervention Patient Questionnaire: The post-intervention patient questionnaire is a brief 24-item investigator-developed knowledge and attitude scale applicable to this population. It includes the same 14 knowledge and attitude items from the pre-intervention survey to assess impact of the educational intervention. It was developed through an expert panel to determine if participants are able to recall key core components about multi-gene panel testing and capture attitudes about genetic testing. There is also a 10-item scale to capture satisfaction with educational intervention. This survey is estimated to take 10 minutes to complete. |
Day 1, after intervention
|
|
Clinician attitudes per "Post Results Clinician Questionnaire"
時間枠：24 months
|
Post-Results Clinician Questionnaire: The post-result clinician questionnaire is a brief 6-item investigator-developed scale to assess whether the genetic testing results altered clinical practice for any given patient including change in disease monitoring, change in recommended treatment, referral to genetic counseling and other parameters. This survey is estimated to take 5 minutes to complete. |
24 months
|
協力者と研究者
スポンサー
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 (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
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。