Effects of Risk Assessment and Counselling on Adherence to Risk Reduction Recommendations Among Female Relatives of Breast Cancer Patients in Southwestern Nigeria
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Ibadan
- Enrollment
- 719
- Locations
- 8
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- Double (Participant, Care Provider)
Masking Description
Participants, Data collectors
Eligibility Criteria
- Ages
- 20 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •Personal history of BC
- •Previous exposure to breast cancer risk assessment and counselling
- •Absence of intact breasts
Outcomes
Primary Outcomes
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Baseline
Statistical analysis will be carried out to determined the independent variables predicting first time to BC screening
Secondary Outcomes
- 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)
Investigators
Agwai Celia Imaria
Epidemiologist
University of Ibadan