Spots Global Cancer Trial Database for Nigerian Breast Cancer Risk-Reduction Study
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Trial Identification
Brief Title: Nigerian Breast Cancer Risk-Reduction Study
Official Title: Effects of Risk Assessment and Counselling on Adherence to Risk Reduction Recommendations Among Female Relatives of Breast Cancer Patients in Southwestern Nigeria
Study ID: NCT05834933
Study Description
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.
Detailed Description:
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: Yes
Locations
Obafemi Awolowo University Teaching Hospital Complex (OAUTHC), Ile-Ife, Osun, Nigeria
University College Hospital (UCH), Ibadan, Oyo, Nigeria
Lagos State University Teaching Hospital (LASUTH), Lagos, , Nigeria
Lagos University Teaching Hospital (LUTH), Lagos, , Nigeria
Contact Details
Name: OLADOSUN A OJENGBEDE, FMCOG, FWACS, FICS, M.B.B.S
Affiliation: CENTER FOR POPULATION AND REPRODUCTIVE HEALTH (CPRH), UNIVERSITY COLLEGE HOSPITAL, IBADAN
Role: PRINCIPAL_INVESTIGATOR
Name: OLADELE O.O KALE, B.A, M.B, B.Ch, B.A.O
Affiliation: University of Ibadan
Role: PRINCIPAL_INVESTIGATOR
Name: IKEOLUWAPO O. AJAYI, MBBS; PhD
Affiliation: University of Ibadan
Role: PRINCIPAL_INVESTIGATOR
Name: CELIA IMARIA AGWAI, M.P.H; Ph.D.
Affiliation: University of Ibadan
Role: PRINCIPAL_INVESTIGATOR
Name: DEZHENG HUO, PhD
Affiliation: University of Chicago
Role: STUDY_DIRECTOR
Name: OLUFUNMILAYO OLOPADE, M.D., F.A.C.P
Affiliation: University of Chicago
Role: STUDY_CHAIR
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