Effects of Risk Assessment and Counselling on Adherence to Risk Reduction Recommendations Among Female Relatives of Breast Cancer Patients in Southwestern Nigeria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 719
- 试验地点
- 8
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Care Provider)
盲法说明
Participants, Data collectors
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Personal history of BC
- •Previous exposure to breast cancer risk assessment and counselling
- •Absence of intact breasts
结局指标
主要结局
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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Baseline
Statistical analysis will be carried out to determined the independent variables predicting first time to BC screening
次要结局
- 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)
研究者
Agwai Celia Imaria
Epidemiologist
University of Ibadan