Nigerian Breast Cancer Risk-Reduction Study
Condition: Risk Reduction Behavior; Breast Cancer; Health Behavior; Health Care Utilization; Health Knowledge, Attitudes, Practice
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      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.
    


Intervention name(s): Individualized breast cancer risk assessment; Individualized breast cancer risk counselling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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
Other intervention name(s): Risk assessment; Counseling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Screening
Keywords: Breast cancer; First-degree relatives; Breast cancer prevention; Risk assessment; Risk counselling; Southwest Nigeria