Improving Colorectal Cancer Screening Uptake Through Education and Stool-Based Testing Outreach
Improving Colorectal Cancer Screening Uptake Through Patient-Centered Education and Mailed Stool-Based Testing Outreach in the Primary Care Medicine Clinic
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Darren Nix
- 電話番号：314-362-3201
- メール：nixd@wustl.edu
研究連絡先のバックアップ
- 名前：Cassandra Fritz, MD, MPHS
- 電話番号：314-454-8165
- メール：cfritz@wustl.edu
研究場所
-
-
Missouri
-
St Louis、Missouri、アメリカ、63110
- Washington University School of Medicine
-
コンタクト：
- Darren Nix
- 電話番号：314-362-3201
- メール：nixd@wustl.edu
-
コンタクト：
- Cassandra Fritz, MD, MPHS
- 電話番号：314-454-8165
- メール：cfritz@wustl.edu
-
副調査官：
- Kamilah Scales, MD
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Phase 1 Education Arm Inclusion Criteria:
- Previously enrolled in prior study IRB #202202059 who agreed to participate in future research
Phase 1 Education Arm Exclusion Criteria:
- Not enrolled in prior study IRB #202202059
Phase 2 (All Other Arms) Inclusion Criteria:
- Primary Care Medicine Clinic patient (PRMC)
- Eligible for CRC screening
- Between age 45-75 years old
- Have eligible health insurance
Phase 2 (All Other Arms) Exclusion Criteria:
- Prior history of colorectal cancer
- Diagnosis of inflammatory bowel disease
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：ふるい分け
- 割り当て：ランダム化
- 介入モデル：並列代入
- 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：Education
Participants will complete the Assessment of Colon Cancer Literacy (ACCL) as a pre-test prior to receiving education materials.
After the pre-test, participants will be provided with ACCL education materials.
Three months after being provided education materials, participants will repeat ACCL testing.
|
Education materials are compiled from the American College of Gastroenterology (ACG) and the City of Hope.
The education materials are at a 6th grade reading level.
Materials detail digestive system and polyp background, colorectal cancer (CRC) risk factors, warning signs, screening options, recommended initial screening age, and stool-based screening and colonoscopy processes.
|
|
実験的：Mailed FIT
Participants will receive a mailed package including 1 FIT test, step-by-step written and pictorial instructions, a prepaid, trackable return envelope, a brief explanation of how the testing works and how results will be communicated, and education materials about CRC. Participants who return kits will complete the Client Satisfaction Questionnaire (CSQ-3) by phone or via MyChart. Participants will be contacted three times by phone as reminders to complete the kit. After three reminders, the team will stop attempting to contact the patient. |
The Fecal immunochemical test (FIT) will be mailed to the participants.
Participants will complete the test via the step-by-step written and pictorial instructions provided and mail the complete test with the pre-paid return label provided.
|
|
実験的：Mailed Cologuard
Participants will receive a mailed package including 1 Cologuard test, step-by-step written and pictorial instructions, a prepaid, trackable return envelope, a brief explanation of how the testing works and how results will be communicated, and education materials about CRC. Participants will have 3 months to return the kit. Participants who return kits will complete the Client Satisfaction Questionnaire (CSQ-3) by phone or via MyChart. Participants will be contacted three times by phone as reminders to complete the kit. After three reminders, the team will stop attempting to contact the patient. |
The Cologuard test will be mailed to the participants.
Participants will complete the test via the step-by-step written and pictorial instructions provided and mail the complete test with the pre-paid return label provided.
|
|
アクティブコンパレータ：Usual Care
Participants will receive usual care from provider after enrollment with no intervention.
Usual care includes providers offering standard screening options including FIT, Cologuard, and colonoscopy at the initial visit with no default option or structured follow-up.
|
Usual care for patients eligible for colorectal cancer screening will be provided by the Barnes-Jewish Hospital Primary Care Medicine Clinic.
|
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 |
|---|---|---|
|
Change in CRC knowledge (Education Arm only)
時間枠：At enrollment and 3 months after educational intervention (total estimated time is 3 months)
|
Change in CRC knowledge will be measured by changes in the score of the Assessment of Colon Cancer Literacy (ACCL) test.
The ACCL consists of 10-items with True/False/Unsure.
The ACCL score ranges from 0 to 10 with a score of 7-10 indicating adequate literacy and scores of 0-6 indicating limited literacy.
|
At enrollment and 3 months after educational intervention (total estimated time is 3 months)
|
|
Feasibility as measured by the percentage of kits returned (Mailed FIT and Mailed Cologuard Arms only)
時間枠：At 3 months after receiving kit (total estimated time 3 months)
|
At 3 months after receiving kit (total estimated time 3 months)
|
|
|
Acceptability of stool based testing (Mailed FIT and Mailed Cologuard Arms only)
時間枠：At completion of testing or at 3 months after receiving test kit (total estimated time 3 months)
|
Acceptability will be assessed using the 3-item Customer Service Questionnaire (CSQ-3).
The 3-items are rated on a 4-point Likert scale as follows: 1=Poor, 2=Fair, 3=Good, and 4=Excellent.
Generally, the higher the score indicates greater customer satisfaction.
|
At completion of testing or at 3 months after receiving test kit (total estimated time 3 months)
|
|
CRC screening completion rate (All arms)
時間枠：From time of receiving CRC kit to 6 months after receiving kit (total estimated time 6 months)
|
CRC screening completion rate will be assessed through electronic health record (EHR) verification of screening completion.
|
From time of receiving CRC kit to 6 months after receiving kit (total estimated time 6 months)
|
協力者と研究者
捜査官
- 主任研究者：Cassandra Fritz, MD, MPHS、Washington University School of Medicine
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 (推定)
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
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。