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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Enrollment
719
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.
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
Obafemi Awolowo University Teaching Hospital Complex (OAUTHC)
Ile-Ife, Osun State, Nigeria
University College Hospital (UCH)
Ibadan, Oyo State, Nigeria
Lagos State University Teaching Hospital (LASUTH)
Lagos, Nigeria
Lagos University Teaching Hospital (LUTH)
Lagos, Nigeria
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
Questionnaire will be administered to the participants to determine the effects of the intervention on adherence to breast screening practices
Time frame: 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
Questionnaire will be administered to the participants to determine the effects of the intervention on adherence to lifestyle risk reduction practices
Time frame: 6 months
Predictors of BSE among first-degree female relatives of BC patients in South-West Nigeria
Statistical analysis will be carried out to determined the independent variables predicting BSE
Time frame: 6 months
Predictors of time to first BC screening post-intervention among first-degree female relatives of BC patients in South-West Nigeria
Statistical analysis will be carried out to determined the independent variables predicting first time to BC screening
Time frame: Baseline
Determine the perception of familial BC risk among first-degree female relatives of BC patients in South-West Nigeria.
Semi-structured questionnaires will be used to determine the perception of familial BC risk among participants
Time frame: Baseline
Determine the knowledge of familiar BC risk among first-degree female relatives of BC patients in South-West Nigeria.
Semi-structured questionnaires will be used to determine the knowledge of familiar BC risk among participants
Time frame: 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
Semi-structured questionnaires will be used to determine the knowledge, attitude, and perception towards genetic testing and BC aetiology among participants
Time frame: Baseline
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