NCT05834933

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
719

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 13, 2017

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2021

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 28, 2023

Completed
Last Updated

August 3, 2023

Status Verified

August 1, 2023

Enrollment Period

4.7 years

First QC Date

March 5, 2023

Last Update Submit

August 2, 2023

Conditions

Risk Reduction BehaviorBreast CancerHealth BehaviorHealth Care UtilizationHealth Knowledge, Attitudes, Practice

Keywords

Breast cancerFirst-degree relativesBreast cancer preventionRisk assessmentRisk counsellingSouthwest Nigeria

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (3)

  • Determine the perception of familial BC risk among first-degree female relatives of BC patients in South-West Nigeria.

    Baseline

  • Determine the knowledge of familiar BC risk among first-degree female relatives of BC patients in South-West Nigeria.

    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

    Baseline

Study Arms (2)

Standard care (SC)

NO INTERVENTION

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

SC + Risk assessment and counselling

EXPERIMENTAL

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 assessmentBehavioral: Individualized breast cancer risk counselling

Interventions

Individualized breast cancer risk assessmentBEHAVIORAL

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.

Also known as: Risk assessment
SC + Risk assessment and counselling
Individualized breast cancer risk counsellingBEHAVIORAL

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

Also known as: Counseling
SC + Risk assessment and counselling

Eligibility Criteria

Age20 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFor this study, first-degree female relatives are mothers, sisters, and daughters of BC patients
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Personal history of BC
  • Previous exposure to breast cancer risk assessment and counselling
  • Absence of intact breasts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Obafemi Awolowo University Teaching Hospital Complex (OAUTHC)

Ile-Ife, Osun State, 5538, Nigeria

Location

University College Hospital (UCH)

Ibadan, Oyo State, 200285, Nigeria

Location

Lagos State University Teaching Hospital (LASUTH)

Lagos, 101233, Nigeria

Location

Lagos University Teaching Hospital (LUTH)

Lagos, 102215, Nigeria

Location

MeSH Terms

Conditions

Risk Reduction BehaviorBreast NeoplasmsHealth BehaviorPatient Acceptance of Health CareBehavior

Interventions

Risk AssessmentCounseling

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesTreatment Adherence and Compliance

Intervention Hierarchy (Ancestors)

RiskProbabilityStatistics as TopicEpidemiologic MethodsInvestigative TechniquesRisk ManagementOrganization and AdministrationHealth Services AdministrationHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public HealthMental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

  • DEZHENG HUO, PhD

    University of Chicago

    STUDY DIRECTOR

  • OLUFUNMILAYO OLOPADE, M.D., F.A.C.P

    University of Chicago

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Participants, Data collectors
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Epidemiologist

Study Record Dates

First Submitted

March 5, 2023

First Posted

April 28, 2023

Study Start

February 13, 2017

Primary Completion

October 29, 2021

Study Completion

October 29, 2021

Last Updated

August 3, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

NG(4)