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: Completed
• Conditions: Breast Cancer; Health Behavior; Health Knowledge, Attitudes, Practice; Health Care Utilization; Risk Reduction Behavior
• Intervention / Treatment: Behavioral: Individualized breast cancer risk assessment; Behavioral: Individualized breast cancer risk counselling

• Study Type: Interventional
• Enrollment (Actual): 719
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nigeria
  • Lagos, Nigeria, 101233
    • Lagos State University Teaching Hospital (LASUTH)
  • Lagos, Nigeria, 102215
    • Lagos University Teaching Hospital (LUTH)
  • Osun
    • Ile-Ife, Osun, Nigeria, 5538
      • Obafemi Awolowo University Teaching Hospital Complex (OAUTHC)
  • Oyo
    • Ibadan, Oyo, Nigeria, 200285
      • University College Hospital (UCH)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. First-degree female relatives of histologically diagnosed BC patients in the study sites
2. Women aged 20 to 75 years of age
3. Willingness to be contacted after six months for follow-up

Exclusion Criteria:

1. Personal history of BC
2. Previous exposure to breast cancer risk assessment and counselling
3. Absence of intact breasts

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

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	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.; Other Names: Risk assessment; 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; Other Names: Counseling

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	Questionnaire will be administered to the participants to determine the effects of the intervention on adherence to breast screening practices	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	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	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	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.	Semi-structured questionnaires will be used to determine the perception of familial BC risk among participants	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	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	Baseline

Collaborators and Investigators

• Sponsor: University of Ibadan
• Collaborators: University College Hospital, Ibadan; Obafemi Awolowo University Teaching Hospital; Lagos University Teaching Hospital (LUTH); Lagos State University Teaching Hospital (LASUTH)
• 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): February 13, 2017
• Primary Completion (Actual): October 29, 2021
• Study Completion (Actual): October 29, 2021

Study Registration Dates

• First Submitted: March 5, 2023
• First Submitted That Met QC Criteria: April 17, 2023
• First Posted (Actual): April 28, 2023

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Breast cancer; Risk assessment; Risk counselling; Breast cancer prevention; First-degree relatives; Southwest Nigeria
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• 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)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No