Precision Navigation to Improve Community Cancer Screening Participation
Effectiveness and Mechanisms of a Precision Navigation Intervention to Improve Community Cancer Screening Participation: A Dual-Cohort Cluster Randomized Controlled Trial
This study will evaluate whether a precision navigation intervention can help community residents at high risk for cancer complete recommended cancer screening. The study will be conducted in communities participating in an urban cancer screening program in China.
Eligible participants will be adults aged 45 to 74 years who are permanent residents of participating communities and have been identified as being at high risk for at least one of five cancers: lung cancer, breast cancer, colorectal cancer, upper gastrointestinal cancer, or liver cancer. Participants must not have completed the corresponding free clinical screening before enrollment.
This is a dual-cohort, cluster randomized controlled trial. Communities, rather than individual participants, will be assigned to one of three groups: a precision navigation group, a usual health education group, or a waiting control group. Participants will be classified into two cohorts according to the number of cancers for which they are assessed as high risk. Cohort A will include participants at high risk for three or more cancers, and Cohort B will include participants at high risk for one or two cancers.
Participants in the precision navigation group will receive a personalized navigation report matched to their risk profile. The report will explain the screening tests most relevant to them, help them understand screening choices, and provide practical steps to support screening completion. Participants in the usual health education group will receive general cancer screening education materials. Participants in the waiting control group will not receive active screening promotion during the main intervention period, but will receive general education materials after the primary assessment.
The main outcome is whether participants complete the recommended cancer screening during follow-up. The study will also assess changes in screening-related decision conflict, anxiety, self-efficacy, and behavioral intention.
The results may help improve community-based cancer screening programs and provide evidence for using personalized navigation strategies to increase screening participation among high-risk populations.
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：Haifan Xiao
- 電話番号：8615580869827
- メール：xiaohaifan@hnca.org.cn
研究場所
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Hunan
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Huaihua、Hunan、中国
- 募集
- Huaihua Central Hospital (Huaihua Cancer Hospital)
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コンタクト：
- Qiang Yan
- 電話番号：8615111549588
- メール：383114173@qq.com
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Shaoyang、Hunan、中国
- 募集
- Shaoyang Hospital of Traditional Chinese Medicine
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コンタクト：
- Liping Deng
- 電話番号：8618473926876
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Yongzhou、Hunan、中国
- 募集
- Yongzhou Central Hospital
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コンタクト：
- Suzhen He
- 電話番号：8613974618396
- メール：25187557@qq.com
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-
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
Inclusion Criteria:
- Aged 45 to 74 years.
- Permanent resident of a participating community, defined as having lived in the community for at least 6 months during the past 12 months.
- Participating in the urban cancer screening program.
- Identified by the program risk assessment questionnaire as being at high risk for at least one of the following cancers: lung cancer, breast cancer, colorectal cancer, upper gastrointestinal cancer, or liver cancer.
- Has not yet completed the corresponding free clinical screening test for the high-risk cancer type or types.
- Able to complete electronic questionnaires and read intervention materials independently or with assistance. Paper materials and staff explanation will be provided for participants who do not use smartphones.
- Able and willing to provide written informed consent.
Exclusion Criteria:
- Previously diagnosed with any of the target cancers, including lung cancer, breast cancer, colorectal cancer, upper gastrointestinal cancer, or liver cancer.
- Severe cognitive impairment, severe mental illness, or other conditions that prevent the participant from receiving the intervention or completing study questionnaires.
- Planning to be away from the community for a long period during the next 6 months, defined as cumulative absence of more than 3 months.
- Currently participating in another interventional study that may affect cancer screening behavior.
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：Usual Health Education Group
Participants in communities assigned to this group will receive general cancer screening health education materials, including information about cancer prevention, early detection, and recommended screening tests.
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Participants in the usual health education group will receive general cancer screening education materials.
The materials will provide basic information about cancer prevention, early detection, and screening for lung cancer, breast cancer, colorectal cancer, upper gastrointestinal cancer, and liver cancer.
The content is not personalized according to the participant's individual risk profile.
|
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介入なし：Waiting Control Group
Participants in communities assigned to this group will not receive active screening promotion during the main intervention period.
They will continue to have access to the free cancer screening services provided by the urban cancer screening program.
General health education materials will be provided after the primary assessment.
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|
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実験的：Precision Navigation Group
Participants in communities assigned to this group will receive a personalized electronic precision navigation report based on their cancer risk profile.
The report will explain the recommended screening tests, support screening decision-making, and provide practical steps to facilitate screening completion.
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Participants in the precision navigation group will receive a personalized navigation report based on their cancer risk profile from the urban cancer screening program.
The report will be tailored according to whether the participant is at high risk for three or more cancers or for one or two cancers.
It will provide individualized information on high-risk cancer types, recommended screening tests, screening procedures, common barriers to screening, and practical action steps.
Trained staff will provide a brief standardized explanation of the report and support participants in making a screening action plan.
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Proportion of Participants Completing Recommended Cancer Screening
時間枠：From enrollment to 6 months after enrollment
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The proportion of enrolled high-risk participants who complete at least one recommended clinical screening test for their corresponding high-risk cancer type or types during follow-up.
Screening completion will be determined using records from the urban cancer screening program information system and participating screening institutions.
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From enrollment to 6 months after enrollment
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Proportion of Participants Completing All Recommended Cancer Screening Tests
時間枠：From enrollment to 3 months after enrollment
|
This outcome is defined as the proportion of participants who complete all cancer screening tests recommended for their individual high-risk cancer profile during follow-up.
Screening completion will be determined using records from the urban cancer screening program information system and participating screening institutions.
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From enrollment to 3 months after enrollment
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協力者と研究者
スポンサー
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
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。