過小評価された集団を臨床試験に結び付けるマルチレベルのアプローチ
フロリダ全体でがんの健康の公平性を促進するための精密臨床試験の募集
The purpose of this study is to pilot test and evaluate an existing tailored ALEX (Agent Leveraging Empathy for eXams) Research Portal to navigate Black and Hispanic adult cancer patients and their family members through referral to cancer clinical trials.
調査の概要
状態
条件
詳細な説明
Racial and ethnic minorities represent the fastest growing segment of the United States adult population, yet they remain significantly underrepresented in cancer clinical trials (CCTs). Low trust in clinical research and recruitment approaches that fail to address multilevel barriers to CCT participation are key reasons for minority population underrepresentation. Community health educators (CHEs) improve trust in research among underrepresented populations, yet relying on exclusively on CHE availability can limit intervention reach. Virtual CHEs (vCHEs) improve scalability by extending CHE capabilities and capitalizing on remote recruitment techniques. The purpose of the current project is to increase referral of diverse participants to NCI-supported clinical trials via a culturally responsive, multi-level intervention that utilizes vCHEs to reach diverse populations. The investigators will consolidate existing referral channels within the ALEX Research Portal. ALEX offers a custom experience for clinicians, CHEs, and patients to facilitate CCT referrals. Clinicians can utilize the portal to refer to CCTs; CHEs can use the portal to create an avatar that can provide introductory information to patients and schedule video-conference follow-ups; patients, families, and community members can use the portal to easily navigate to key information and make self-and other-referrals. The ability to streamline information to patients and CCT referrals to study coordinators is expected to improve the overall referral to CCTs. The ALEX Research Portal utilizes the adaptive virtual human technology developed at the University of Florida that provides users with culturally and linguistically tailored CCT information. The ALEX Research Portal will be developed and launched across three distinct geographic areas of Florida (Gainesville, Jacksonville, and Miami). This unique collaborative opportunity will provide access to participants representative of the racial and ethnic diversity of the state as well as cancer centers conducting CCTs associated with national networks [Experimental Therapeutics Clinical Trials Network (ETCTN), National Clinical Trials Network (NCTN)]. Guided by the Interactive Systems Framework for dissemination and implementation, our goal is to increase referrals to CCTs by optimizing the ALEX Research Portal for broad use. The outcome will be an evidence-based intervention that can be widely disseminated to quickly increase the referral of diverse patients to CCTs. This project will be conducted in three phases: (Phase I) establish a baseline of referrals and accrual of diverse participants to CCTs across multiple Florida Center Centers, (Phase 2) adapt and pilot the ALEX Research Portal using a randomized controlled clinical trial, and (Phase 3) scale the intervention by dissemination via the OneFlorida network. The proposed study will result in an empirically-tested vCHE Research Portal for increasing trust in CCTs among diverse populations that can easily be adapted and disseminated across the state to overcome challenges associated with recruiting diverse participants to CCTs.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Clinical Trials Referral Office
- 電話番号：855-776-0015
- メール：mayocliniccancerstudies@mayo.edu
研究連絡先のバックアップ
- 名前：ETCH Lab
- 電話番号：904-953-5375
- メール：ETCH@mayo.edu
研究場所
-
-
Florida
-
Gainesville、Florida、アメリカ、32611
- まだ募集していません
- University of Florida
-
コンタクト：
- Benjamin Lok, PhD
- 電話番号：352-214-9829
- メール：LOK@CISE.UFL.EDU
-
主任研究者：
- Benjamin Lok, PhD
-
Jacksonville、Florida、アメリカ、32224
- 募集
- Mayo Clinic in Florida
-
主任研究者：
- Janice Krieger, PhD
-
コンタクト：
- Clinical Trials Referral Office
- 電話番号：855-776-0015
- メール：mayocliniccancerstudies@mayo.edu
-
コンタクト：
- ETCH Lab
- 電話番号：904-953-5375
- メール：ETCH@mayo.edu
-
Miami、Florida、アメリカ、33136
- まだ募集していません
- University of Miami
-
コンタクト：
- Olveen Carrasquillo, MD
- 電話番号：305-243-9765
- メール：OCarrasquillo@med.miami.edu
-
主任研究者：
- Olveen Carrasquillo, MD
-
-
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
Black/African American and Latino/Hispanic participants living in Florida.
説明
Inclusion Criteria:
- An adult 18 to 100 years of age,
- Able to read English or Spanish at least an eighth-grade level,
- From a racial/ethnic background historically underrepresented in cancer clinical trials (e.g. Blacks or African Americans and/or Hispanics or Latinos),
- Have an email account or the ability to receive texts,
- Willingness to be re-contacted,
- Be a resident of the state of Florida.
Exclusion Criteria:
- Unable to read English or Spanish at least at eighth-grade level
- Does not have an email account or the ability to receive texts
- Unwilling to be re-contacted
- Non resident of the state of Florida.
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：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Stand-alone Portal
The standard of care condition will include a portal that provides patients with access to existing online cancer clinical trial resources in one location. This includes links to pages with basic information about cancer clinical trials, ongoing studies, enrollment opportunities for existing institutional research registries, and contact information for study coordinators. |
The standard of care condition will include a portal that provides patients with access to existing online cancer clinical trial resources in one location. This includes links to pages with basic information about cancer clinical trials, ongoing studies, enrollment opportunities for existing institutional research registries, and contact information for study coordinators. |
|
Portal with Virtual Community Health Educator (vCHE)
The virtual community health educator condition will provide all information in standard of care with the addition of a virtual community health educator. Patients will have the opportunity to choose which virtual community health educator will provide digital navigation. The choices will include at least four English-speaking and four Spanish-speaking virtual community health educators representing different genders and racial/ethnic backgrounds. |
The virtual community health educator condition will provide all information in standard of care with the addition of a virtual community health educator. Patients will have the opportunity to choose which virtual community health educator will provide digital navigation. The choices will include at least four English-speaking and four Spanish-speaking virtual community health educators representing different genders and racial/ethnic backgrounds. |
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 patients who self-refer to cancer clinical trials
時間枠：Within two 2 months of consent
|
Patients from underrepresented groups will be recruited in this study and equally randomized into either a) standard-of-care web-based educational portal about clinical trials or a b) a web-based portal that includes a virtual Community Health Educator. Participants in both conditions will have the opportunity to self-refer (operationalized as expressing interest in being contacted) to a cancer clinical trial. The numbers of patients referred to a cancer clinical trial will be collected in both treatment groups and the proportions compared to determine whether adding a virtual Community Health Educator to web-based educational resources about cancer clinical trials will increase referrals of minority patients. Patients are assigned into 2 groups, and the outcome measure is the number of self-referrals after treatment divided by the total number of patients for both groups. |
Within two 2 months of consent
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Virtual Clinical Health Education (vCHE) preferences
時間枠：Within two months of consent
|
Participants assigned to the portal with the virtual Community Health Educator (vCHE) will be able to choose a vCHE among a set with different characteristics. Data on participant preferences for particular vCHE characteristics will be collected. The measure is the count number of the participants that choose the different characteristics of vCHE. |
Within two months of consent
|
|
Change in trust in Cancer Clinical Trials
時間枠：Within two months of consent
|
Participants who access the portal will first complete a Clinical Trials Attitudes questionnaire (pre-test) that assesses trust in cancer clinical trials (CCTs). Participants will complete the Clinical Trials Attitudes questionnaire (post-test) after interacting with the vCHE. The Clinical Trials Attitudes questionnaire consists of 14 questions answered on a 5-point scale (strongly agree, agree, neither agree nor disagree, disagree, or strongly disagree) The change in responses to the Likert-scale items between the pre-intervention questionnaire and the post-intervention questionnaire will be the change in trust in CCTs. |
Within two months of consent
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Janice Krieger, PhD、Mayo Clinic
研究記録日
主要日程の研究
研究開始 (実際)
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
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- IRB202201399
- U01CA274970 (米国 NIH グラント/契約)
- 24-003323 (その他の識別子：Mayo Clinic Institutional Review Board)
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。