Nigerian Breast Cancer Risk-Reduction Study

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.

Conditions

• Risk Reduction Behavior
• Breast Cancer
• Health Behavior
• Health Care Utilization
• Health Knowledge, Attitudes, Practice

Interventions

BEHAVIORAL

Individualized breast cancer risk assessment

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.

BEHAVIORAL

Individualized breast cancer risk counselling

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

Sponsors & Collaborators

• Lagos State University Teaching Hospital (LASUTH)

  collaborator UNKNOWN

• Obafemi Awolowo University Teaching Hospital

  collaborator OTHER

• Lagos University Teaching Hospital (LUTH)

  collaborator UNKNOWN

• University College Hospital, Ibadan

  collaborator OTHER

• University of Ibadan

  lead OTHER

Principal Investigators

• OLADOSUN A OJENGBEDE, FMCOG, FWACS, FICS, M.B.B.S · CENTER FOR POPULATION AND REPRODUCTIVE HEALTH (CPRH), UNIVERSITY COLLEGE HOSPITAL, IBADAN

• OLADELE O.O KALE, B.A, M.B, B.Ch, B.A.O · University of Ibadan

• IKEOLUWAPO O. AJAYI, MBBS; PhD · University of Ibadan

• CELIA IMARIA AGWAI, M.P.H; Ph.D. · University of Ibadan

• DEZHENG HUO, PhD · University of Chicago

• OLUFUNMILAYO OLOPADE, M.D., F.A.C.P · University of Chicago

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

75 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-02-13

Primary Completion

2021-10-29

Completion

2021-10-29

Countries

• Nigeria

Study Locations