Nigerian Breast Cancer Risk-Reduction Study

Breast Cancer Clinical Trial

— NBCRS  

Official title:

Effects of Risk Assessment and Counselling on Adherence to Risk Reduction Recommendations Among Female Relatives of Breast Cancer Patients in Southwestern Nigeria

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05834933
• Other study ID #: NHREC/05/01/2008a
• Status: Completed
• Phase: N/A
• Start date: February 13, 2017
• Est. completion date: October 29, 2021

Study information

• Verified date: August 2023
• Source: University of Ibadan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 719
• Est. completion date: October 29, 2021
• Est. primary completion date: October 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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

Locations

Country	Name	City	State
Nigeria	University College Hospital (UCH)	Ibadan	Oyo
Nigeria	Obafemi Awolowo University Teaching Hospital Complex (OAUTHC)	Ile-Ife	Osun
Nigeria	Lagos State University Teaching Hospital (LASUTH)	Lagos
Nigeria	Lagos University Teaching Hospital (LUTH)	Lagos

Sponsors (5)

Lead Sponsor	Collaborator
University of Ibadan	Lagos State University Teaching Hospital (LASUTH), Lagos University Teaching Hospital (LUTH), Obafemi Awolowo University Teaching Hospital, University College Hospital, Ibadan

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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