Partnership for Healthy Seniors
Cancer Prevention and Treatment Among African American Older Adults: Screening Trial
The Centers for Medicare and Medicaid Services (CMS) has awarded cooperative agreements to 6 sites from across the country (Salt Lake City, UT, Molokai, HI, Houston, TX, Newark, NJ, Detroit, MI, and Baltimore City) to participate in a national 4-year demonstration (September 15, 2006 to September 30, 2010). One goal of the demonstration is to reduce disparities in cancer screening among seniors from U.S. racial and ethnic minority populations. Each site will focus on a specific racial/ethnic minority group, and collaborate with CMS in project implementation. A Core questionnaire, the Cancer Screening Assessment (CSA) will be administered at baseline to all participants in the demonstration. Participant identification, randomization, and intervention implementation will be standardized across sites.
Goal: The proposal developed by the Johns Hopkins Bloomberg School of Public Health in collaboration with the Baltimore City Community Health Coalition is designed to address persistent disparities in screening for breast, cervix, colon/rectum and prostate cancer among Baltimore City's seniors.
Primary Objective: Conduct a randomized controlled trial (target N = 2,874) within a project, to compare the efficacy of 2 interventions that differ in intensity to improve continuity and outcomes of care among African Americans seniors.
Among African American seniors, compared to a less intensive intervention (general information and educational materials), does the addition of facilitation services delivered by a health coordinator result in a greater improvement in adherence to cancer screening recommendations among those who are not known to have cancer?
Study Population: We will recruit African American residents of Baltimore, age 65 years or older, and currently enrolled in Medicare Parts A and B. (Baltimore City's 82,202 seniors represent 13% of its population, and account for 68% of the City's cancer deaths. Among these seniors, 96% have Medicare Parts A and B, 54.5% have income levels at less than 250% of the federal poverty guideline, and 55.6% are African American.)
Eligible participants will respond to a baseline questionnaire, Cancer Screening Assessment (CSA). They will then be randomized to receive a less intensive or more intensive intervention. The less intensive group will receive general information about cancer and Medicare covered services, and instructions to discuss the information with their primary care doctor. The more intensive group will receive the same information as the less intensive group receives, plus tailored facilitation services delivered by a nurse-supervised community health worker. The primary outcome variable will be the difference between randomized groups in adherence to screening for breast, cervix, colon/rectum and prostate cancer.
A community advisory committee will guide all aspects of the study and will include important stake holders (both public and private sectors), representatives from the Baltimore City Community Health Coalition, the Baltimore City Department of Health, the Maryland Department of Health and Mental Hygiene, community leaders, consumers, health care providers (physicians, oncologists, nurse practitioners, physician assistants, nurses, social workers, pathologists) and academicians.
調査の概要
状態
詳細な説明
Among African American seniors, compared to a less intensive intervention (general information and educational materials), does the addition of facilitation services delivered by a health coordinator result in a greater improvement in adherence to cancer screening recommendations among those who are not known to have cancer?
Background
The Centers for Medicare and Medicaid Services (CMS) received congressional authorization to launch a nationwide demonstration project to address persistent disparities in cancer prevention among racial and ethnic minority populations. Hopkins was selected as one of six national sites to conduct a demonstration project designed to test an intervention strategy to promote adherence to cancer screening among African American seniors residing in Baltimore.
Aim
This demonstration project will evaluate the efficacy of a health coordinator model in cancer screening for older African American adults in Baltimore, Maryland.
We will conduct A RANDOMIZED CONTROLLED TRIAL testing the efficacy of the model intervention in facilitating screening services for individuals who are not known to have cancer. The duration of follow-up post-randomization will be from date of randomization and September 30th, 2010, the end date for the demonstration.
We will 1) implement a population-based recruitment strategy in tandem with convenience sampling, targeting African American Medicare enrollees who reside in Baltimore, and are not known to have cancer; and 2) conduct a randomized controlled trial comparing the efficacy of a less intensive intervention (general information and educational materials in the context of "usual care") to that of a more intensive intervention, the addition of a health coordinator (HC), in promoting adherence to cancer screening.
The null hypothesis to be tested in this trial is that "the proportion of participants in the more intensive intervention group who complete at least one of the recommended screenings is equal to that of participants in the less intensive intervention group."
The primary outcome variable for the trial will be the difference between the two intervention groups in the proportion of participants who complete at least one of the recommended screenings.
Population: A total of 2874 study participants will be accrued from the Medicare enrollment database, which will be stratified by gender and age (65-74 year olds and 75 plus years).
The study population will consist of older African American Medicare beneficiaries who reside in Baltimore. The sampling frame will be restricted to African American Medicare beneficiaries, age 65 and older, Baltimore residents enrolled in Medicare Parts A and B, but not enrolled in managed care (Medicare Part C), hospice, or some other extended care facility. With a population of 651,154, African Americans constitute 64% of Baltimore City's total population44. Additionally, 13.2% of Baltimoreans are age 65 or older, and this accounts for 68% of the City's cancer deaths.
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
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Maryland
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Baltimore、Maryland、アメリカ、21205
- Bloomberg School of Public Health
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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:
- Age 65 or older;
- Residence in Baltimore;
- Enrolled in Medicare Part A;
- Enrolled in Medicare Part B of Title XVIII of the Social Security Act;
- Provided informed consent;
- Must be free from cancer or in remission for 5 years or more
Exclusion Criteria:
- Age less than 65;
- Residence outside of Baltimore;
- Enrollment in Medicare managed care (Part C);
- Residence in a chronic care facility or otherwise institutionalized;
- Planning to move within the next year;
- Unable or unwilling to give informed consent;
- Diagnosed with cancer within 5 years or less;
- Diagnosed with cancer more than 5 years ago, but cancer in remission for less than 5 years
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 |
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アクティブコンパレータ：2
Individuals randomized to this arm receive the following interventions: 1) educational materials on recommended cancer-preventive services, plus 2) a health coordinator (patient navigator) who helps the participant schedule and keep appointments for cancer screening and/or treatment.
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Individuals randomized to receive the less intensive intervention receive educational materials only.
Those randomized to the more intensive intervention are assigned a health coordinator (patient navigator) who delivers an enhanced, tailored educational intervention after review of the participant's screening history and knowledge gaps about cancer.
The health coordinator also facilitate adherence to cancer screening and/or treatment services, by assisting in scheduling and keeping of appointments for cancer-related screening and/or treatment services.
A brochure is provided to the participant with information about preventive services covered by Medicare, and the frequency with which those services should be obtained.
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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 |
時間枠 |
|---|---|
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Difference between the two intervention groups in the proportion of participants who complete at least one of the recommended screenings.
時間枠：Number of days from date of randomization to date of completion of participation in the study
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Number of days from date of randomization to date of completion of participation in the study
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Adherence to maintenance screening.
時間枠：Number of days beyond extended window for completion of a specific screening test
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Number of days beyond extended window for completion of a specific screening test
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Timely notification of abnormal screening results.
時間枠：Number of days between detection of an abnormal screening result and participant notification about the results
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Number of days between detection of an abnormal screening result and participant notification about the results
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Timely follow up with specialist following abnormal screening result.
時間枠：From date of detection of an abnormal screening result to date of visit with specialist
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From date of detection of an abnormal screening result to date of visit with specialist
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Timely diagnosis following abnormal result.
時間枠：From date of detection of an abnormal screening result to date of diagnosis
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From date of detection of an abnormal screening result to date of diagnosis
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Timely treatment start-up.
時間枠：Number of days from the date of diagnosis to date of initiation of therapy
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Number of days from the date of diagnosis to date of initiation of therapy
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Improved utilization of Medicare-covered preventive services.
時間枠：From date of randomization to date of completion of participation in the study
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From date of randomization to date of completion of participation in the study
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Stage at diagnosis.
時間枠：At the time of diagnosis
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At the time of diagnosis
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協力者と研究者
捜査官
- 主任研究者：Adrian Dobs, MD、Johns Hopkins University
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
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 (見積もり)
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。
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