- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05834933
Nigerian Breast Cancer Risk-Reduction Study (NBCRS)
Effects of Risk Assessment and Counselling on Adherence to Risk Reduction Recommendations Among Female Relatives of Breast Cancer Patients in Southwestern Nigeria
The study will be a randomized controlled trial. The aim of the study is to determine the Breast Cancer (BC) risk and to evaluate the effect of BC risk counseling on lifestyle changes and adherence to risk-reduction practices among first-degree female relatives of BC patients in South-West Nigeria. This study's research questions are:
- What are the Nigeria Breast Cancer Study (NBCS) and Gail models estimates of the BC risk of first-degree female relatives of BC patients in South-West, Nigeria?
- What are the effects of BC risk assessment and counseling on adherence to breast screening recommendations among first-degree female relatives of BC patients in South-West, Nigeria?
- What are the effects of BC risk assessment and counseling on adherence to lifestyle risk reduction recommendations among first-degree female relatives of BC patients in South-West, Nigeria?
- What is the knowledge, attitudes, and perception of first-degree female relatives of BC patients in South-West Nigeria towards genetic testing and BC etiology?
- What factors predict breast screening among first-degree female relatives of BC patients in South-West Nigeria?
- What factors predict the time to first BC screening (post-intervention) among first-degree female relatives of BC patients in South-West Nigeria?
Participants will be randomized into the control arm (standard care) and intervention arms of the study. The intervention arm of the study will have a BC risk assessment followed by individualized BC risk counseling. In addition, the intervention arm will receive BC awareness and MammaCare® BSE training. The control arm will receive only standard care comprising BC awareness and MammaCare® BSE training. Both study arms will receive BC screening recommendations and lifestyle modification recommendations.
We hope that the BC risk counseling will improve BC screening practices and modification of risk behaviors and this hypothesis will be tested.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Lagos, Nigeria, 101233
- Lagos State University Teaching Hospital (LASUTH)
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Lagos, Nigeria, 102215
- Lagos University Teaching Hospital (LUTH)
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Osun
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Ile-Ife, Osun, Nigeria, 5538
- Obafemi Awolowo University Teaching Hospital Complex (OAUTHC)
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Oyo
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Ibadan, Oyo, Nigeria, 200285
- University College Hospital (UCH)
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- First-degree female relatives of histologically diagnosed BC patients in the study sites
- Women aged 20 to 75 years of age
- Willingness to be contacted after six months for follow-up
Exclusion Criteria:
- Personal history of BC
- Previous exposure to breast cancer risk assessment and counselling
- Absence of intact breasts
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Standard care (SC)
Participants received one-on-one breast cancer awareness education; one-on-one monthly Breast Self-Examination (BSE) training; general breast cancer screening recommendations; and general lifestyle modification recommendations
|
|
Experimental: SC + Risk assessment and counselling
Participants received Standard care as described in the SC arm above in addition to individualized breast cancer risk assessment, individualized breast cancer risk counseling, and lifestyle risk reduction recommendations
|
Individualized breast cancer risk assessment: The Nigerian Breast Cancer Study (NBCS) absolute risk prediction model was used to predict the 5-year and lifetime breast cancer risks of the participants.
The model utilized individual breast cancer risk factors.
Other Names:
Individualized breast cancer risk counselling: The Principal Investigator (PI) and other trained risk counsellors discussed the results of the NBCS risk prediction model with participants and counselled them about the risk of developing breast cancer.
The
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effects of BC risk assessment and counselling on adherence to breast screening recommendations among first-degree female relatives of BC patients in South-West Nigeria
Time Frame: 6 months
|
Questionnaire will be administered to the participants to determine the effects of the intervention on adherence to breast screening practices
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6 months
|
Effects of BC risk assessment and counselling on adherence to lifestyle risk reduction recommendations among first-degree female relatives of BC patients in South-West, Nigeria
Time Frame: 6 months
|
Questionnaire will be administered to the participants to determine the effects of the intervention on adherence to lifestyle risk reduction practices
|
6 months
|
Predictors of BSE among first-degree female relatives of BC patients in South-West Nigeria
Time Frame: 6 months
|
Statistical analysis will be carried out to determined the independent variables predicting BSE
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6 months
|
Predictors of time to first BC screening post-intervention among first-degree female relatives of BC patients in South-West Nigeria
Time Frame: Baseline
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Statistical analysis will be carried out to determined the independent variables predicting first time to BC screening
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine the perception of familial BC risk among first-degree female relatives of BC patients in South-West Nigeria.
Time Frame: Baseline
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Semi-structured questionnaires will be used to determine the perception of familial BC risk among participants
|
Baseline
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Determine the knowledge of familiar BC risk among first-degree female relatives of BC patients in South-West Nigeria.
Time Frame: Baseline
|
Semi-structured questionnaires will be used to determine the knowledge of familiar BC risk among participants
|
Baseline
|
Determine the knowledge, attitude, and perception towards genetic testing and BC aetiology among first-degree female relatives of BC patients in South-West Nigeria
Time Frame: Baseline
|
Semi-structured questionnaires will be used to determine the knowledge, attitude, and perception towards genetic testing and BC aetiology among participants
|
Baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: OLADOSUN A OJENGBEDE, FMCOG, FWACS, FICS, M.B.B.S, CENTER FOR POPULATION AND REPRODUCTIVE HEALTH (CPRH), UNIVERSITY COLLEGE HOSPITAL, IBADAN
- Principal Investigator: OLADELE O.O KALE, B.A, M.B, B.Ch, B.A.O, University of Ibadan
- Principal Investigator: IKEOLUWAPO O. AJAYI, MBBS; PhD, University of Ibadan
- Principal Investigator: CELIA IMARIA AGWAI, M.P.H; Ph.D., University of Ibadan
- Study Director: DEZHENG HUO, PhD, University Of Chicago
- Study Chair: OLUFUNMILAYO OLOPADE, M.D., F.A.C.P, University Of Chicago
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NHREC/05/01/2008a (UI/UCH ETHICS COMMITTEE)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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