Lay Health Worker Outreach in Increasing Colorectal Cancer Screening in Asian Americans
The National Center for Reducing Asian American Cancer Health Disparities Research Project on Lay Health Workers and Asian Americans (AANCART)
調査の概要
状態
詳細な説明
PRIMARY OBJECTIVES:
I. Evaluate the efficacy of lay health worker (LHWs) outreach on colorectal cancer (CRC) screening among 3 Asian American groups (Filipinos, Hmong, and Koreans) in a cluster randomized controlled trial (RCT) comparing CRC education delivered by LHWs (intervention) to a CRC brochure and nutrition education (control).
II. Examine the processes through which LHWs communicate with, connect to, and convince community members from 3 Asian American cultures of the importance of CRC screening using mixed methods.
OUTLINE: Lay health workers (LHWs) are randomized to 1 of 2 groups.
GROUP I (CRC EDUCATION): LHWs undergo training over 3 days and recruit 15 participants from their social network. Participants attend a CRC educational session conducted by an LHW over 90 minutes at month 1 and 3. Participants receive phone calls from the LHW at months 2 and 4 reminding them about CRC screening.
GROUP II (CRC BROCHURE): LHWs undergo training over 3 days and recruit 15 participants from their social network. Participants attend a lecture on healthy nutrition for cardiovascular health presented by a professional health educator at months 1 and 3. After the first meeting, participants receive a brochure on CRC screening. Participants receive phone calls from the LHW at months 2 and 4 regarding changes in their nutritional behavior. Participants may attend an optional post-intervention LHW outreach session on CRC screening.
After completion of the study, patients are followed up at 2 months.
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
-
-
California
-
Los Angeles、California、アメリカ、90095
- UCLA / Jonsson Comprehensive Cancer Center
-
Sacramento、California、アメリカ、95817
- University of California Davis Comprehensive Cancer Center
-
San Francisco、California、アメリカ、94115
- University of California, San Francisco
-
-
Hawaii
-
Honolulu、Hawaii、アメリカ、96813
- University of Hawaii Cancer Center
-
-
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:
- LHW: self-identified as Filipino, Hmong, or Korean Americans
- LHW: age 18 or older
- LHW: are fluent in a Filipino language (Tagalog or Ilocano), Hmong, Korean, or English
- LHW: Live in the relevant area and intend to stay there for the next 12 months
- PARTICIPANTS: Self-identified as Filipino, Hmong, or Korean Americans
- PARTICIPANTS: speak a language that the LHW can speak such as Tagalog, Ilocano, Hmong, Korean, or English
- PARTICIPANTS: live in relevant area and intend to stay there for at least 12 months
- PARTICIPANTS: Are willing to participate in a study about health behaviors involving nutrition or CRC screening
Exclusion Criteria:
- Personal history of CRC
- Medical problems which may prevent them from attending 2 educational sessions
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：防止
- 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：Group I (CRC education)
LHWs undergo training over 3 days and recruit 15 participants from their social network.
Participants attend a CRC educational session conducted by an LHW over 90 minutes at month 1 and 3. Participants receive phone calls from the LHW at months 2 and 4 reminding them about CRC screening.
|
補助研究
Attend CRC education session
他の名前：
Attend healthy nutrition session
他の名前：
Receive telephone reminder about CRC screening
Receive telephone reminder about healthy nutrition
|
|
アクティブコンパレータ：Group II (CRC brochure)
LHWs undergo training over 3 days and recruit 15 participants from their social network.
Participants attend a lecture on healthy nutrition for cardiovascular health presented by a professional health educator at months 1 and 3.
After the first meeting, participants receive a brochure on CRC screening.
Participants receive phone calls from the LHW at months 2 and 4 regarding changes in their nutritional behavior.
Participants may attend an optional post-intervention LHW outreach session on CRC screening.
|
補助研究
Attend CRC education session
他の名前：
Attend healthy nutrition session
他の名前：
Receive telephone reminder about CRC screening
Receive telephone reminder about healthy nutrition
Receive CRC screening brochure
|
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 |
|---|---|---|
|
Proportion of participants who report ever having had a CRC screening test
時間枠：Baseline to 6 months
|
Bivariable and multivariable analyses of the binary outcomes (CRC screening ever, up-to-date, and intention) will be conducted using generalized linear models to evaluate the efficacy of the intervention.
A linear model with identity link function will be used with group (intervention or control), time (pre- or post-), and group-by-time interaction to test for a difference in the change from pre- to post-intervention between the 2 groups, thus measuring the efficacy of the intervention.
|
Baseline to 6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of participants who are up-to-date for CRC screening
時間枠：At 6 months
|
Bivariable and multivariable analyses of the binary outcomes (CRC screening ever, up-to-date, and intention) will be conducted using generalized linear models to evaluate the efficacy of the intervention.
|
At 6 months
|
|
Proportion of participants who intend to obtain CRC screening in the next 6 months
時間枠：At 6 months
|
Bivariable and multivariable analyses of the binary outcomes (CRC screening ever, up-to-date, and intention) will be conducted using generalized linear models to evaluate the efficacy of the intervention.
|
At 6 months
|
協力者と研究者
捜査官
- 主任研究者：Tung Nguyen、University of California, San Francisco
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 (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
本研究に関する用語
その他の研究ID番号
- 11056 (DAIDS ES Registry Number)
- U54CA153499 (米国 NIH グラント/契約)
- NCI-2017-00515 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。
結腸直腸癌の臨床試験
-
Taichung Veterans General Hospital完了心毒性 | 非小細胞肺癌（MeSH用語：Carcinoma, Non-Small-Cell Lung） | 薬物関連の副作用および有害反応（MeSH用語） | EGFRチロシンキナーゼ阻害剤台湾
-
Fondazione del Piemonte per l'Oncologia募集乳がん | 卵巣がん | 結腸直腸がん | 黒色腫 (皮膚がん) | 非小細胞肺癌（MeSH用語：Carcinoma, Non-Small-Cell Lung）イタリア
アンケート管理の臨床試験
-
Fondazione Policlinico Universitario Agostino Gemelli...まだ募集していません
-
Fondazione Poliambulanza Istituto Ospedalieroわからない