Clinical trial NCT05834933: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risk Reduction Behavior
Breast Cancer
Health Behavior
Health Care Utilization
Health Knowledge, Attitudes, Practice
Keywords: Breast cancer
First-degree relatives
Breast cancer prevention
Risk assessment
Risk counselling
Southwest Nigeria
Lead sponsor: University of Ibadan
Sponsor class: OTHER
Collaborators: name: Lagos State University Teaching Hospital (LASUTH)
name: Obafemi Awolowo University Teaching Hospital
name: Lagos University Teaching Hospital (LUTH)
name: University College Hospital, Ibadan
First posted: 2023-04-28
Enrollment: 719
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


Eligibility criteria: Inclusion Criteria:

1. First-degree female relatives of histologically diagnosed BC patients in the study sites
2. Women aged 20 to 75 years of age
3. Willingness to be contacted after six months for follow-up

Exclusion Criteria:

1. Personal history of BC
2. Previous exposure to breast cancer risk assessment and counselling
3. Absence of intact breasts

Primary outcomes:
measure: 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
timeFrame: 6 months
measure: 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
timeFrame: 6 months
measure: Predictors of BSE among first-degree female relatives of BC patients in South-West Nigeria
timeFrame: 6 months
measure: Predictors of time to first BC screening post-intervention among first-degree female relatives of BC patients in South-West Nigeria
timeFrame: Baseline
Secondary outcomes:
measure: Determine the perception of familial BC risk among first-degree female relatives of BC patients in South-West Nigeria.
timeFrame: Baseline
measure: Determine the knowledge of familiar BC risk among first-degree female relatives of BC patients in South-West Nigeria.
timeFrame: Baseline
measure: Determine the knowledge, attitude, and perception towards genetic testing and BC aetiology among first-degree female relatives of BC patients in South-West Nigeria
timeFrame: Baseline
Other outcomes:
Locations:
city: Ile-Ife
country: Nigeria
facility: Obafemi Awolowo University Teaching Hospital Complex (OAUTHC)
state: Osun
city: Ibadan
country: Nigeria
facility: University College Hospital (UCH)
state: Oyo
city: Lagos
country: Nigeria
facility: Lagos State University Teaching Hospital (LASUTH)
city: Lagos
country: Nigeria
facility: Lagos University Teaching Hospital (LUTH)
Study officials:
affiliation: CENTER FOR POPULATION AND REPRODUCTIVE HEALTH (CPRH), UNIVERSITY COLLEGE HOSPITAL, IBADAN
name: OLADOSUN A OJENGBEDE, FMCOG, FWACS, FICS, M.B.B.S
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ibadan
name: OLADELE O.O KALE, B.A, M.B, B.Ch, B.A.O
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ibadan
name: IKEOLUWAPO O. AJAYI, MBBS; PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ibadan
name: CELIA IMARIA AGWAI, M.P.H; Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: DEZHENG HUO, PhD
role: STUDY_DIRECTOR
affiliation: University of Chicago
name: OLUFUNMILAYO OLOPADE, M.D., F.A.C.P
role: STUDY_CHAIR
References: