Awareness Enhancing Interventions (AWEI)
2021年10月19日 更新者：MICHELLE Y MARTIN、University of Tennessee
Increasing Recruitment of Underrepresented Cancer Survivors With Awareness Enhancing Interventions
The purpose of this study is to determine if increasing awareness and, thus, enhancing positive attitudes about research, prior to recruitment attempts, will increase participation in cancer clinical research among African American (AA) cancer survivors so that recruitment efforts can focus on the most optimal and cost- effective approaches
調査の概要
状態
募集
介入・治療
- 他の：Navigation - Study Specific - Researcher Voice
- 他の：Navigation - Study Specific - Cancer Survivor Voice
- 他の：Navigation - Research General - Researcher Voice
- 他の：Navigation - Research General - Cancer Survivor Voice
- 他の：Brochure - Study Specific - Researcher Voice
- 他の：Brochure - Study Specific - Cancer Survivor Voice
- 他の：Brochure - Research General - Researcher Voice
- 他の：Brochure - Research General - Cancer Survivor Voice
詳細な説明
In this project, 2000 AA potential AMPLIFI project participants will be randomized to the awareness-enhancing intervention (AWEI) or to the comparison condition in which they do not receive AWEI intervention but only the Adapting Multiple Behavior Interventions that Effectively Improve Cancer Survivor Health (AMPLIFI) basic recruitment strategy (No AWEI).
Randomization for the AWEI Randomized Controlled Trial (RCT) will occur soon after the AMPLIFI recruitment letter is sent, and AWEI interventions will be delivered over a two-week period between the AMPLIFI recruitment invitation letter and the AMPLIFI recruitment call.
Survivors randomized to AWEI intervention will be exposed to 8 different combinations of the AWEI components according to different types of strategies and type of information reflecting the survivor voice or not.
Subsequent to the AMPLIFI recruitment call, a 20% random sample of cancer survivors will be surveyed over the phone to assess intervention fidelity.
研究の種類
介入
入学 (予想される)
2000
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Michelle Y Martin, PhD
- 電話番号：901.448.2383
- メール：mmart126@uthsc.edu
研究連絡先のバックアップ
- 名前：Catherine E womack, BA
- 電話番号：9014481189
- メール：ewomack5@uthsc.edu
研究場所
-
-
Alabama
-
Birmingham、Alabama、アメリカ、35294
- 募集
- University of Alabama at Birmingham
-
コンタクト：
- Maria Pisu, PhD
- メール：mpisu@uabmc.edu
-
コンタクト：
- Aquila Brown Galvan, MPH
- メール：abgalvan@uabmc.edu
-
-
Tennessee
-
Memphis、Tennessee、アメリカ、38105
- 募集
- University of Tennessee Health Science Center
-
コンタクト：
- Catherine E womack, BA
- 電話番号：9014481189
- メール：ewomack5@uthsc.edu
-
コンタクト：
- Michelle Y Martin
- 電話番号：901-448-2383
- メール：mmart126@uthsc.edu
-
主任研究者：
- Michelle Y Martin, PhD
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
50年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- African American/Black
- adults (age ≥50 years old)
- diagnosed with obesity/physical activity associated cancers that have a 70% or greater 5-year relative cancer-free survival rate multiple myeloma, localized kidney cancer and loco- regional cancers of the colorectum, female breast, prostate, endometrium, and ovary).
- 1-5 years post diagnosis
- reside in an area with wireless coverage
- In the AMPLIFI recruitment pool
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：他の
- 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 |
|---|---|
|
介入なし：Control Group
This group will receive no intervention before receiving the AMPLIFI Recruitment Call
|
|
|
他の：Navigation
After receiving recruitment letter from AMPLIFI, participant randomized to this arm will receive a phone call from a Research Specialist who will discuss the importance of research participation for cancer survivors to increase research awareness and aid in recruitment.
The information will focus on the importance of research and will be delivered from the perspective of either a researcher or a cancer survivor.
|
The intervention is delivered over the telephone
The intervention is delivered over the telephone
The intervention is delivered over the telephone
The intervention is delivered over the telephone
|
|
他の：Brochure
After receiving recruitment letter from AMPLIFI, participant randomized to this arm will receive a brochure which will focus on the importance of research participation for cancer survivors in order to increase research awareness and aid in recruitment.
|
The invention is mailed to the participant in a brochure.
The invention is mailed to the participant in a brochure.
The invention is mailed to the participant in a brochure.
The invention is mailed to the participant in a 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 |
|---|---|---|
|
recruitment yield
時間枠：within 3 months of receiving intervention
|
measured by the proportion of targeted survivors who, at the time of the recruitment call, after the screening process is complete, decide to participate in AMPLIFI.
|
within 3 months of receiving intervention
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Interest in Participating in the AMPLIFI Study
時間枠：within 3 months of receiving intervention
|
proportion of survivors who express interest in participating and return the consent form to the AMPLIFI team.
|
within 3 months of receiving intervention
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Michelle Y Marttin, PhD、University of Tennessee
- 主任研究者：Maria Pisu, PhD、University of Alabama at Birmingham
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2021年4月12日
一次修了 (予想される)
2022年8月1日
研究の完了 (予想される)
2023年3月30日
試験登録日
最初に提出
2020年12月19日
QC基準を満たした最初の提出物
2020年12月19日
最初の投稿 (実際)
2020年12月24日
学習記録の更新
投稿された最後の更新 (実際)
2021年10月25日
QC基準を満たした最後の更新が送信されました
2021年10月19日
最終確認日
2021年10月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 300002068-B
- R01CA242737-01A1 (米国 NIH グラント/契約)
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?
はい
IPD プランの説明
We will share data which will include the AMPLIFI final disposition code (recruited versus not recruited), the impact of the AWEI interventions versus the standard recruitment approach.
IPD 共有時間枠
All data will be shared once all primary outcomes papers have been published (consonant with the NIH definition of "timely fashion") but no later than within one year of the completion of the funded study.
IPD 共有アクセス基準
The access to the data will be granted to investigators working in an organization with a Federal Wide Assurance (FWA).
Before access is granted, individuals must provide a copy of their Institutional Review Board (IRB) approval to use the data to answer their specific study questions.
Individuals in receipt of data must produce proof of human subjects and HIPAA training.
All datasets will conform to the "Standards for Privacy of Individually Identifiable Health Information" rule of HIPAA.
In order to maintain HIPAA compliance, we will provide a limited-use dataset (i.e., stripped of identifying information).
Requesting users will be required to sign a data-use sharing agreement.
Although not immediately precluded, data deemed to be "sensitive" will be added to limited use datasets only after careful consideration.
Resulting publications must credit the funding for this grant.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
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
いいえ
米国FDA規制機器製品の研究
いいえ
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。