Mobile Health Patient Navigation for the Improvement of Screening and the Early Detection of Breast Cancer in Women Accessing Primary Care Clinics in Kenya
A Multi-Level Strategy for Integrating Information Technology and Mobile Health to Strengthen Linkages to Breast Cancer Screening and Early Detection Among Women Utilizing Primary Care in Kenya (MATITI YANGU)
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
- 他の:Discussion
- 他の:Interview - Stakeholder
- 他の:Survey Administration
- 他の:Interview - Key Informant
- 他の:Best Practice
- 他の:Interview - Ancillary studies
- 他の:Survey Administration - Ancillary studies
- 行動:Patient Navigation - C Components
- 行動:Patient Navigation - B components
- 行動:Patient Navigation - A components
詳細な説明
PRIMARY OBJECTIVES:
I. To design and evaluate a multi-component, multi-level, evidence-informed, m-Health-supported package of interventions and delivery strategies to promote uptake and access to resource stratified and guideline-informed breast cancer screening and early detection services in Kenya.
II. To identify and select candidate interventions that are effective in promoting uptake and access to breast cancer screening and early detection.
III. To implement a package and strategies of m-Health supported evidence-based interventions for screening and early detection of breast cancer.
IV. To evaluate feasibility (recruitment, retention, implementation) of each strategy, and identify the most effective strategy (or combination of strategies), for the lowest cost.
OUTLINE:
AIM 1: Participants complete a focus group over 60-90 minutes in support of the identification and selection of evidence-based interventions (EBIs) on study.
AIM 2: Participants are assigned to 1 of 2 groups.
GROUP I: Participants complete a stakeholder interview and complete surveys to further inform EBI adaptation and implementation on study.
GROUP II: Participants complete a key informant interview and complete surveys to further inform EBI adaptation and implementation on study.
AIM 3: Patients are randomized to 1 of 8 arms.
ARM 1: Patients receive enhanced usual care (EUC) which may consist of viewing a motivational and educational peer testimonial video, motivational interviewing regarding breast health and cancer screening, and/or being offered clinical breast examination (CBE) access followed by standardized follow-up counseling about screening MMG or guideline-based recommendations on the need for further diagnostic testing on study.
ARM 2: Patients receive EUC as in arm I and adapted m-Health PN strategy C components on study.
ARM 3: Patients receive EUC as in arm I and adapted m-Health PN strategy B components on study.
ARM 4: Patients receive EUC as in arm I and adapted m-Health PN strategy B and C components on study.
ARM 5: Patients receive EUC as in arm I and adapted m-Health PN strategy A components on study.
ARM 6: Patients receive EUC as in arm I and adapted m-Health PN strategy A and C components on study.
ARM 7: Patients receive EUC as in arm I and adapted m-Health PN strategy A and B components on study.
ARM 8: Patients receive EUC as in arm I and adapted m-Health PN strategy A, B, and C components on study.
After completion of study intervention, patients are followed up at 3 and 6 months and at study completion.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究場所
-
-
Georgia
-
Atlanta、Georgia、アメリカ、30322
- 募集
- Emory University Hospital/Winship Cancer Institute
-
主任研究者:
- Michael Chung
-
コンタクト:
- Michael Chung
- 電話番号:404-251-4012
- メール:michael.h.chung@emory.edu
-
-
参加基準
適格基準
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:
- AIM 1: All members of BREAKTHROUGH's Stakeholder Advisory Board (SAB) breast cancer working group
- AIM 1: Participants (patients and health providers) from primary health care clinics in Nairobi County
- AIM 1: Will include women (patients) aged over 35 years and speak either Kiswahili or English
AIM 1: Include women who:
- Have never undergone MMG screening
- Previously undergone MMG screening
- Experienced breast abnormalities and have been referred for or undergone diagnostic investigations
- Are currently undergoing or have received breast cancer treatment
- AIM 1: Health care providers and breast screening facility staff (i.e. primary care clinic nurses, MMG clinic staff and technicians) will also be recruited
- AIM 2: Will engage with a diverse group of local and national interagency stakeholders, Nairobi County health leadership, and health providers across different levels of the health system
- AIM 3: Women aged 35 years and older who are able to provide informed consent who are attending the outpatient clinics for primary health care
- AIM 4: Members of SAB breast cancer group, health facilities leadership (all health facility levels)
Exclusion Criteria:
- AIM 1: Those who will be unwilling to consent and those who are unable to consent will be excluded from the study
- AIM 2: Those who will be unwilling to consent and those who are unable to consent will be excluded from the study
- AIM 3: Women undergoing breast cancer treatment and women aged 70 years and above will be excluded
- AIM 4: Members of SAB breast cancer group, and health facilities leadership who will be unwilling and unable to consent will be excluded
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:順次割り当て
- マスキング:独身
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的:Aim 1 (focus group)
Participants complete a focus group over 60-90 minutes in support of the identification and selection of EBIs on study.
|
Complete a focus group
他の名前:
|
|
実験的:Aim 2 group I (stakeholder interview, surveys)
Participants complete a stakeholder interview and complete surveys to further inform EBI adaptation and implementation on study.
|
Complete stakeholder interview
Complete EBI adaptation and implementation surveys
|
|
実験的:Aim 2 group II (key informant interview, surveys)
Participants complete a key informant interview and complete surveys to further inform EBI adaptation and implementation on study.
|
Complete EBI adaptation and implementation surveys
Complete key informant interview
|
|
アクティブコンパレータ:Aim 3 arm 1 (EUC)
Patients receive EUC which may consist of viewing a motivational and educational peer testimonial video, motivational interviewing regarding breast health and cancer screening, and/or being offered CBE access followed by standardized follow-up counseling about screening MMG or guideline-based recommendations on the need for further diagnostic testing on study.
|
Receive EUC
他の名前:
Ancillary studies
Ancillary studies
|
|
実験的:Aim 3 arm 2 (EUC, PN strategy C)
Patients receive EUC as in arm I and adapted m-Health PN strategy C components on study.
|
Receive EUC
他の名前:
Ancillary studies
Ancillary studies
Receive adapted m-Health PN strategy C components
他の名前:
|
|
実験的:Aim 3 arm 3 (EUC, PN strategy B)
Patients receive EUC as in arm I and adapted m-Health PN strategy B components on study.
|
Receive EUC
他の名前:
Ancillary studies
Ancillary studies
Receive adapted m-Health PN strategy B components
他の名前:
|
|
実験的:Aim 3 arm 4 (EUC, PN strategy B and C)
Patients receive EUC as in arm I and adapted m-Health PN strategy B and C components on study.
|
Receive EUC
他の名前:
Ancillary studies
Ancillary studies
Receive adapted m-Health PN strategy C components
他の名前:
Receive adapted m-Health PN strategy B components
他の名前:
|
|
実験的:Aim 3 arm 5 (EUC, PN strategy A)
Patients receive EUC as in arm I and adapted m-Health PN strategy A components on study.
|
Receive EUC
他の名前:
Ancillary studies
Ancillary studies
Receive adapted m-Health PN strategy A components
他の名前:
|
|
実験的:Aim 3 arm 6 (EUC, PN strategy A and C)
Patients receive EUC as in arm I and adapted m-Health PN strategy A and C components on study.
|
Receive EUC
他の名前:
Ancillary studies
Ancillary studies
Receive adapted m-Health PN strategy C components
他の名前:
Receive adapted m-Health PN strategy A components
他の名前:
|
|
実験的:Aim 3 arm 7 (EUC, PN strategy A and B)
Patients receive EUC as in arm I and adapted m-Health PN strategy A and B components on study.
|
Receive EUC
他の名前:
Ancillary studies
Ancillary studies
Receive adapted m-Health PN strategy B components
他の名前:
Receive adapted m-Health PN strategy A components
他の名前:
|
|
実験的:Aim 3 arm 8 (EUC, PN strategy A, B, and C)
Patients receive EUC as in arm I and adapted m-Health PN strategy A, B, and C components on study.
|
Receive EUC
他の名前:
Ancillary studies
Ancillary studies
Receive adapted m-Health PN strategy C components
他の名前:
Receive adapted m-Health PN strategy B components
他の名前:
Receive adapted m-Health PN strategy A components
他の名前:
|
この研究は何を測定していますか?
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Adapted evidence-based intervention (EBI) delivery strategies (Aim 1)
時間枠:Up to 2 years
|
The research team will have two independent members who will translate and code the transcripts of the focus group discussions (FGDs).
They will be using the Capability, Opportunity, and Motivation-based Behavior model to categorize and code the barriers and opportunities associated with the implementation of candidate evidence-based intervention.
Topic prompts related to factors that facilitate EBI implementation will be thematically coded to inform selection and adaptation of EBI delivery (implementation) strategies.
|
Up to 2 years
|
|
Health system resources, training, and requirements for EBI implementation (Aim 2)
時間枠:Up to 4 years
|
Will use descriptive statistics to analyze quantitative data from the Service Availability and Readiness Assessment survey, service mapping, Technology Acceptance Model, and Organizational Readiness for Implementing Change.
FGDs and key informant interviews will be digitally recorded, transcribed, then translated into English by an experienced study translator.
Experienced study team members, supported by trainees, will develop codebooks using an iterative, abductive technique, which allows coders to reference the Consolidated Framework for Implementation Research (CFIR), the process will involve remaining receptive to informative deviations.
The coding process will start with reading the transcripts individually to detect initial themes, patterns, and questions that can generate ideas.
Then, focused coding will be conducted to identify concepts that cluster together, organize thoughts, identify major themes that emerge, and connect them to relevant CFIR constructs.
|
Up to 4 years
|
|
Access to screening mammography (MMG) for eligible asymptomatic women (Aim 3)
時間枠:Up to 6 months
|
The primary method of data collection will be through verification of completion of navigation points in the care pathway of each participant.
The data will also be verified by a trained research assistant at 3 and 6 months and study completion through review of medical records in the health facilities and phone communication audits with the participants.
Will utilize blinded outcome assessors to check for fidelity and other outcomes that require data collection for verification through manual review of facility medical records (paper-based patient registers).
|
Up to 6 months
|
|
Access to diagnostic MMG or breast ultrasound for women who have a breast abnormality identified on clinical breast examination offered at the clinic (Aim 3)
時間枠:Up to 6 months
|
The primary method of data collection will be through verification of completion of navigation points in the care pathway of each participant.
The data will also be verified by a trained research assistant at 3 and 6 months and study completion through review of medical records in the health facilities and phone communication audits with the participants.
Will utilize blinded outcome assessors to check for fidelity and other outcomes that require data collection for verification through manual review of facility medical records (paper-based patient registers).
|
Up to 6 months
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to MMG screening (Aim 3)
時間枠:Up to 2 years
|
The primary method of data collection will be through verification of completion of navigation points in the care pathway of each participant.
The data will also be verified by a trained research assistant at 3 and 6 months and study completion through review of medical records in the health facilities and phone communication audits with the participants.
Will utilize blinded outcome assessors to check for fidelity and other outcomes that require data collection for verification through manual review of facility medical records (paper-based patient registers).
|
Up to 2 years
|
|
Time to diagnostic MMG (Aim 3)
時間枠:Up to 2 years
|
The primary method of data collection will be through verification of completion of navigation points in the care pathway of each participant.
The data will also be verified by a trained research assistant at 3 and 6 months and study completion through review of medical records in the health facilities and phone communication audits with the participants.
Will utilize blinded outcome assessors to check for fidelity and other outcomes that require data collection for verification through manual review of facility medical records (paper-based patient registers).
|
Up to 2 years
|
|
Time to breast ultrasound (Aim 3)
時間枠:Up to 2 years
|
The primary method of data collection will be through verification of completion of navigation points in the care pathway of each participant.
The data will also be verified by a trained research assistant at 3 and 6 months and study completion through review of medical records in the health facilities and phone communication audits with the participants.
Will utilize blinded outcome assessors to check for fidelity and other outcomes that require data collection for verification through manual review of facility medical records (paper-based patient registers).
|
Up to 2 years
|
|
Time to breast biopsy (if required) (Aim 3)
時間枠:Up to 2 years
|
The primary method of data collection will be through verification of completion of navigation points in the care pathway of each participant.
The data will also be verified by a trained research assistant at 3 and 6 months and study completion through review of medical records in the health facilities and phone communication audits with the participants.
Will utilize blinded outcome assessors to check for fidelity and other outcomes that require data collection for verification through manual review of facility medical records (paper-based patient registers).
|
Up to 2 years
|
|
Time to participant receipt of screening MMG result (Aim 3)
時間枠:Up to 2 years
|
The primary method of data collection will be through verification of completion of navigation points in the care pathway of each participant.
The data will also be verified by a trained research assistant at 3 and 6 months and study completion through review of medical records in the health facilities and phone communication audits with the participants.
Will utilize blinded outcome assessors to check for fidelity and other outcomes that require data collection for verification through manual review of facility medical records (paper-based patient registers).
|
Up to 2 years
|
|
Time to receipt of ultrasound and/or biopsy result (Aim 3)
時間枠:Up to 2 years
|
The primary method of data collection will be through verification of completion of navigation points in the care pathway of each participant.
The data will also be verified by a trained research assistant at 3 and 6 months and study completion through review of medical records in the health facilities and phone communication audits with the participants.
Will utilize blinded outcome assessors to check for fidelity and other outcomes that require data collection for verification through manual review of facility medical records (paper-based patient registers).
|
Up to 2 years
|
|
Proportion of participants who receive access to the entire (or partial) screening and diagnosis care pathway (Aim 3)
時間枠:Up to 2 years
|
The primary method of data collection will be through verification of completion of navigation points in the care pathway of each participant.
The data will also be verified by a trained research assistant at 3 and 6 months and study completion through review of medical records in the health facilities and phone communication audits with the participants.
Will utilize blinded outcome assessors to check for fidelity and other outcomes that require data collection for verification through manual review of facility medical records (paper-based patient registers).
|
Up to 2 years
|
協力者と研究者
協力者
協力者
捜査官
捜査官
- 主任研究者:Michael Chung、Emory University Hospital/Winship Cancer Institute
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- STUDY00008713 (その他の識別子:Emory University Hospital/Winship Cancer Institute)
- P30CA138292 (米国 NIH グラント/契約)
- U54CA284036 (米国 NIH グラント/契約)
- NCI-2025-05473 (レジストリ識別子:CTRP (Clinical Trial Reporting Program))
- EU6635-25 (その他の識別子:Emory University Hospital/Winship Cancer Institute)
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
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