Trials / Completed
CompletedNCT05834933
Nigerian Breast Cancer Risk-Reduction Study
Effects of Risk Assessment and Counselling on Adherence to Risk Reduction Recommendations Among Female Relatives of Breast Cancer Patients in Southwestern Nigeria
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 719 (actual)
- Sponsor
- University of Ibadan · Academic / Other
- Sex
- Female
- Age
- 20 Years – 75 Years
- Healthy volunteers
- Accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2017-02-13
- Primary completion
- 2021-10-29
- Completion
- 2021-10-29
- First posted
- 2023-04-28
- Last updated
- 2023-08-03
Locations
4 sites across 1 country: Nigeria
Source: ClinicalTrials.gov record NCT05834933. Inclusion in this directory is not an endorsement.