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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.
Age
20 - 75 years
Sex
FEMALE
Healthy Volunteers
Yes
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
Start Date
February 13, 2017
Primary Completion Date
October 29, 2021
Completion Date
October 29, 2021
Last Updated
August 3, 2023
719
ACTUAL participants
Individualized breast cancer risk assessment
BEHAVIORAL
Individualized breast cancer risk counselling
BEHAVIORAL
Lead Sponsor
University of Ibadan
Collaborators
NCT05372640
NCT05673200
Data Source & Attribution
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