An interventional study of Individualized breast cancer risk assessment and Individualized breast cancer risk counselling in Risk Reduction Behavior, Breast Cancer and Health Behavior, sponsored by University of Ibadan. Completed at 4 sites in Nigeria. Open to female participants aged 20 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-03.
Sponsored by University of Ibadan · Not applicable, Interventional, and Screening
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:
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 719 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Ibadan is the lead sponsor of 21 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants received one-on-one breast cancer awareness education; one-on-one monthly Breast Self-Examination (BSE) training; general breast cancer screening recommendations; and general lifestyle modification recommendations
Participants received Standard care as described in the SC arm above in addition to individualized breast cancer risk assessment, individualized breast cancer risk counseling, and lifestyle risk reduction recommendations
Behavioral: Individualized breast cancer risk assessment · Behavioral: Individualized breast cancer risk counselling
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.
Also known as: Risk assessment
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
Also known as: Counseling
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
Time frame: 6 months
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
Time frame: 6 months
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
Time frame: 6 months
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
Time frame: Baseline
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
Time frame: Baseline
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
Time frame: 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
Semi-structured questionnaires will be used to determine the knowledge, attitude, and perception towards genetic testing and BC aetiology among participants
Time frame: Baseline
Plan to share: No
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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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University of Ibadan