Breast CancerNCT05321823
Improving Access to Breast Cancer Screening and Treatment in Nigeria: The Triple Mobile Assessment and Patient Navigation Model
A study testing iBreast device, Clinical Breast Examination and Breast ultrasound in people with Breast Cancer, run by Obafemi Awolowo University at 1 site in Nigeria.
Trial summary
The goal of this study is to establish a novel community-based breast cancer program to address delayed presentation and lack of access to diagnostic and treatment facilities in South-West Nigeria. Read more about this study
- Who is it for?
- Ages 30 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- iBreast device, Clinical Breast Examination and Breast ultrasound
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,100 participants
- Where
- 1 siteNigeria
- Study dates
- 8 Dec 2021to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Asymptomatic women 40 - 70 years
- Symptomatic women (with breast-related symptoms) 30 - 70 years
Who cannot join
- Male subjects
- Women living outside the study locations (Ife East and Ife North districts)
Trial locations and contacts
1 site in 1 country.
Nigeria1 site, 1 recruiting
- Recruiting
Obafemi Awolowo University Teaching Hospitals Complex
Ile-Ife, Osun State, 220213
Adeleye D Omisore, MBBS, M.Sc, FWACS, FMCR, +2348031538004, leyeomisore@oauife.edu.ng
Adeleye D Omisore, MBBS, M.Sc, FWACS, FMCR
About this study
The goal of this study is to establish a novel community-based breast cancer program to address delayed presentation and lack of access to diagnostic and treatment facilities in South-West Nigeria. It is aimed at evaluating the impact of a novel breast cancer early detection program using triple mobile assessment (innovative handheld iBreast Exam [iBE] device, mobile ultrasound, and mobile mammography) and patient navigation program in a Nigerian community.
Read the detailed description
This study aims to provide screening to asymptomatic women 40-70 years and to provide diagnostic evaluation to women 30-70 years presenting with breast symptoms in a community in South-West Nigeria.
The project will use a cluster randomized design with 1 community serving as the intervention arm and another community serving as the control arm. Both communities will receive breast cancer awareness and education but only the intervention community will receive screening, mobile imaging and navigation. Screening with targeted clinical history, Clinical Breast Exam (CBE), and iBE will be performed by trained Community Health Nurses in the intervention community. Women with positive CBE or iBE findings will undergo breast imaging with mobile mammography and portable ultrasound, as well as biopsy when indicated by the Radiologist who visits the community once a month, and receive navigation by the nurses to the point of care. The control population will receive breast cancer awareness without an organized screening, imaging or navigation program. Women presenting to the Primary Health Care Centers in the control community will be referred to the Teaching Hospital as per current standard of care. Record of all breast cancer cases seen in the 2 communities during the study period will be obtained.
- Conditions
- Breast Cancer
- Being tested
- iBreast device, Clinical Breast Examination, Breast ultrasound, Mammography
- Keywords
- Screening, Treatment, Navigation, Triple Mobile assessment
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iBreast deviceDevice
Also called UE Life Sciences Inc.
The iBreast (iBE) device is an automated, battery powered, portable device designed to be used by community health nurses as a screening and triage tool. The iBE is designed to be used by a community health worker or lay person after appropriate training. In resource-limited settings, it potentially provides an easily accessible, low-cost method to assess the breast for findings that warrant further evaluation.
Clinical Breast ExaminationOther
Also called CBE
The standard clinical breast examination (CBE) will be performed by the community health nurses in the selected primary health care centers where patients will present for screening or diagnostic workup in the intervention community
Breast ultrasoundDiagnostic test
Women in the intervention community who have positive iBE and/or CBE findings will be navigated by the community health nurses to have ultrasound with or without ultrasound-guided breast biopsy if indicated by the radiologist using portable ultrasound tablets that will be brought to the intervention community.
MammographyDiagnostic test
Women in the intervention community who have positive iBE and/or CBE findings will be navigated by the community health nurses to have mammography done using a mobile mammography van that will be brought to the intervention community.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Two districts in Ife East Local County with an estimated screening population of 4,500 will be randomly selected to serve as the control community. The control arm will not receive iBE screening and clinical breast examinations by the community health nurses and nor get navigated to have ultrasound, mammography, biopsy and referral for treatment to the tertiary hospital if indicated within their community. All women for screening and diagnostic workup in the control community will be directed to the tertiary hospital to receive breast care. |
| Intervention | Experimental | Three districts in Ife North Local County with an estimated screening population (women 40-70 years) of 5,800 will be randomly selected to serve as the intervention community. Women in the intervention community will receive iBreast and clinical breast examinations by the community health nurses and get navigated to have ultrasound, mammography, biopsy and referral for treatment to the tertiary hospital if indicated within their community. Receives: Device: iBreast device; Other: Clinical Breast Examination; Diagnostic Test: Breast ultrasound; Diagnostic Test: Mammography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation rate
Percentage of women screened of the total number of eligible women in each community.
Measured: After year 1 of the 2-year study period
Abnormal call rate
Number of women with abnormalities detected on iBE and/or CBE requiring further evaluation either by imaging or biopsy out of the total number of women screened.
Measured: After year 1 of the 2-year study period
Breast cancer detection rate
Number of histologically diagnosed cases of breast cancer per 1,000 screened populations.
Measured: After year 1 of the 2-year study period
Stage at presentation
The tumour, node and metastasis (TNM) stage among those with histologically confirmed breast cancer.
Measured: After year 1 of the 2-year study period
Timeline from presentation to treatment
Time interval between presentation for screening in the community and treatment in the tertiary hospital
Measured: After year 1 of the 2-year study period
Retention rate
Number of women who return for repeat annual screening of the total initial number of women screened.
Measured: After year 2 of the 2-year study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start8 Dec 2021
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be carried out in 2 local counties (Local Government Areas) in Osun State, South-West, Nigeria, Ife North Local County and Ife East Local County. Three districts in Ife North Local County with an estimated screening population (women 40-70 years) of 5,800 will be randomly selected to serve as the intervention community, while 2 districts in Ife East Local County with an estimated screening population of 4,500 will be randomly selected to serve as the control community. Both communities will receive awareness and education, but only the intervention community will receive screening and navigation.
- Masking
- None (open label)
- Enrolment
- 4,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Obafemi Awolowo University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Adeleye Omisore, Obafemi Awolowo University
- Investigators
- Adeleye D Omisore, MBBS, M.Sc, FWACS, FMCR, Principal investigator, Obafemi Awolowo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05321823
- Sponsor's protocol ID
- ERC/2020/10/11 (26/10/2020)
- Other IDs
- #60303257
- Status last verified
- Apr 2022
- First submitted
- 24 Mar 2022
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The study protocol, statistical analysis plan, and informed consent form will be made available on clinicaltrials.gov if and when required. With study data being uploaded to redcap hosted by the sponsor organization (Obafemi Awolowo University), de-identified individual participant data can be made available under the terms of a data use agreement 12 moths after publication of study results.
Publications
Omisore AD, Olasehinde O, Wuraola FO, Sutton EJ, Sevilimedu V, Omoyiola OZ, Romanoff A, Owoade IA, Olaitan AF, Kingham TP, Alatise OI, Mango VL. Improving access to breast cancer screening and treatment in Nigeria: The triple mobile assessment and patient navigation model (NCT05321823): A study protocol. PLoS One. 2023 Jun 13;18(6):e0284341. doi: 10.1371/journal.pone.0284341. eCollection 2023.
PubMed 37310983
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Access to Breast Cancer Screening and Treatment in Nigeria: The Triple Mobile Assessment and Patient Navigation Model
- ClinicalTrials.gov ID
- NCT05321823
- Acronym / sponsor ID
- ERC/2020/10/11 (26/10/2020)
- Conditions
- Breast Cancer
- Keywords
- Screening, Treatment, Navigation, Triple Mobile assessment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,100 participants (estimated)
- Lead sponsor
- Obafemi Awolowo UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 8 Dec 2021 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 11 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to establish a novel community-based breast cancer program to address delayed presentation and lack of access to diagnostic and treatment facilities in South-West Nigeria. It is aimed at evaluating the impact of a novel breast cancer early detection program using triple mobile assessment (innovative handheld iBreast Exam [iBE] device, mobile ultrasound, and mobile mammography) and patient navigation program in a Nigerian community.
Detailed description
This study aims to provide screening to asymptomatic women 40-70 years and to provide diagnostic evaluation to women 30-70 years presenting with breast symptoms in a community in South-West Nigeria.
The project will use a cluster randomized design with 1 community serving as the intervention arm and another community serving as the control arm. Both communities will receive breast cancer awareness and education but only the intervention community will receive screening, mobile imaging and navigation. Screening with targeted clinical history, Clinical Breast Exam (CBE), and iBE will be performed by trained Community Health Nurses in the intervention community. Women with positive CBE or iBE findings will undergo breast imaging with mobile mammography and portable ultrasound, as well as biopsy when indicated by the Radiologist who visits the community once a month, and receive navigation by the nurses to the point of care. The control population will receive breast cancer awareness without an organized screening, imaging or navigation program. Women presenting to the Primary Health Care Centers in the control community will be referred to the Teaching Hospital as per current standard of care. Record of all breast cancer cases seen in the 2 communities during the study period will be obtained.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will be carried out in 2 local counties (Local Government Areas) in Osun State, South-West, Nigeria, Ife North Local County and Ife East Local County. Three districts in Ife North Local County with an estimated screening population (women 40-70 years) of 5,800 will be randomly selected to serve as the intervention community, while 2 districts in Ife East Local County with an estimated screening population of 4,500 will be randomly selected to serve as the control community. Both communities will receive awareness and education, but only the intervention community will receive screening and navigation.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Two districts in Ife East Local County with an estimated screening population of 4,500 will be randomly selected to serve as the control community. The control arm will not receive iBE screening and clinical breast examinations by the community health nurses and nor get navigated to have ultrasound, mammography, biopsy and referral for treatment to the tertiary hospital if indicated within their community. All women for screening and diagnostic workup in the control community will be directed to the tertiary hospital to receive breast care. |
| Intervention | Experimental | Device: iBreast device, Other: Clinical Breast Examination, Diagnostic Test: Breast ultrasound, Diagnostic Test: MammographyThree districts in Ife North Local County with an estimated screening population (women 40-70 years) of 5,800 will be randomly selected to serve as the intervention community. Women in the intervention community will receive iBreast and clinical breast examinations by the community health nurses and get navigated to have ultrasound, mammography, biopsy and referral for treatment to the tertiary hospital if indicated within their community. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Asymptomatic women 40 - 70 years
- Symptomatic women (with breast-related symptoms) 30 - 70 years
Key exclusion criteria (2 listed)
- Male subjects
- Women living outside the study locations (Ife East and Ife North districts)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iBreast deviceAlso: UE Life Sciences Inc.The iBreast (iBE) device is an automated, battery powered, portable device designed to be used by community health nurses as a screening and triage tool. The iBE is designed to be used by a community health worker or lay person after appropriate training. In resource-limited settings, it potentially provides an easily accessible, low-cost method to assess the breast for findings that warrant further evaluation. | Device | Intervention |
| Clinical Breast ExaminationAlso: CBEThe standard clinical breast examination (CBE) will be performed by the community health nurses in the selected primary health care centers where patients will present for screening or diagnostic workup in the intervention community | Other | Intervention |
| Breast ultrasoundWomen in the intervention community who have positive iBE and/or CBE findings will be navigated by the community health nurses to have ultrasound with or without ultrasound-guided breast biopsy if indicated by the radiologist using portable ultrasound tablets that will be brought to the intervention community. | Diagnostic test | Intervention |
| MammographyWomen in the intervention community who have positive iBE and/or CBE findings will be navigated by the community health nurses to have mammography done using a mobile mammography van that will be brought to the intervention community. | Diagnostic test | Intervention |
Primary outcome
Participation rate
Time frame: After year 1 of the 2-year study period
Percentage of women screened of the total number of eligible women in each community.
Abnormal call rate
Time frame: After year 1 of the 2-year study period
Number of women with abnormalities detected on iBE and/or CBE requiring further evaluation either by imaging or biopsy out of the total number of women screened.
Breast cancer detection rate
Time frame: After year 1 of the 2-year study period
Number of histologically diagnosed cases of breast cancer per 1,000 screened populations.
Stage at presentation
Time frame: After year 1 of the 2-year study period
The tumour, node and metastasis (TNM) stage among those with histologically confirmed breast cancer.
Timeline from presentation to treatment
Time frame: After year 1 of the 2-year study period
Time interval between presentation for screening in the community and treatment in the tertiary hospital
Retention rate
Time frame: After year 2 of the 2-year study period
Number of women who return for repeat annual screening of the total initial number of women screened.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Derived from this study: PubMed 37310983Omisore AD, Olasehinde O, Wuraola FO, Sutton EJ, Sevilimedu V, Omoyiola OZ, Romanoff A, Owoade IA, Olaitan AF, Kingham TP, Alatise OI, Mango VL. Improving access to breast cancer screening and treatment in Nigeria: The triple mobile assessment and patient navigation model (NCT05321823): A study protocol. PLoS One. 2023 Jun 13;18(6):e0284341. doi: 10.1371/journal.pone.0284341. eCollection 2023.
- Individual participant dataSharing planned: Yes. The study protocol, statistical analysis plan, and informed consent form will be made available on clinicaltrials.gov if and when required. With study data being uploaded to redcap hosted by the sponsor organization (Obafemi Awolowo University), de-identified individual participant data can be made available under the terms of a data use agreement 12 moths after publication of study results.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adeleye D Omisore, MBBS, M.Sc, FWACS, FMCR principal investigator
Obafemi Awolowo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iBreast device, Clinical Breast Examination and Breast ultrasound in people with Breast Cancer, run by Obafemi Awolowo University at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adeleye D Omisore, MBBS, M.Sc, FWACS, FMCR (+234803538004, leyeomisore@oauife.edu.ng), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation rate (time frame: After year 1 of the 2-year study period). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05321823, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.