Breast Cancer, Health Behavior, Health Care Utilization, Health Knowledge, Attitudes, Practice, Risk Reduction Behavior
Conditions
Keywords
Breast cancer, First-degree relatives, Breast cancer prevention, Risk assessment, Risk counselling, Southwest Nigeria
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.
Interventions
BEHAVIORALIndividualized 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.
BEHAVIORALIndividualized 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
Lagos State University Teaching Hospital (LASUTH)
Obafemi Awolowo University Teaching Hospital
Lagos University Teaching Hospital (LUTH)
University College Hospital, Ibadan
University of Ibadan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Caregiver)
Masking description
Participants, Data collectors
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 6 months | Questionnaire will be administered to the participants to determine the effects of the intervention on adherence to breast screening practices |
| 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 | 6 months | Questionnaire will be administered to the participants to determine the effects of the intervention on adherence to lifestyle risk reduction practices |
| Predictors of BSE among first-degree female relatives of BC patients in South-West Nigeria | 6 months | Statistical analysis will be carried out to determined the independent variables predicting BSE |
| Predictors of time to first BC screening post-intervention among first-degree female relatives of BC patients in South-West Nigeria | Baseline | Statistical analysis will be carried out to determined the independent variables predicting first time to BC screening |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine the knowledge of familiar BC risk among first-degree female relatives of BC patients in South-West Nigeria. | Baseline | Semi-structured questionnaires will be used to determine the knowledge of familiar BC risk among participants |
| 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 | Semi-structured questionnaires will be used to determine the knowledge, attitude, and perception towards genetic testing and BC aetiology among participants |
| Determine the perception of familial BC risk among first-degree female relatives of BC patients in South-West Nigeria. | Baseline | Semi-structured questionnaires will be used to determine the perception of familial BC risk among participants |
Countries
Nigeria
Outcome results
None listed