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NBCRS: Nigerian Breast Cancer Risk-Reduction Study

Sponsor
University of Ibadan (Other)
Overall Status
Completed
CT.gov ID
NCT05834933
Collaborator
Lagos State University Teaching Hospital (LASUTH) (Other), Obafemi Awolowo University Teaching Hospital (Other), Lagos University Teaching Hospital (LUTH) (Other), University College Hospital, Ibadan (Other)
719
Enrollment
4
Locations
2
Arms
56.5
Actual Duration (Months)
179.8
Patients Per Site
3.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Individualized breast cancer risk assessment
  • Behavioral: Individualized breast cancer risk counselling
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
719 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Masking Description:
Participants, Data collectors
Primary Purpose:
Screening
Official Title:
Effects of Risk Assessment and Counselling on Adherence to Risk Reduction Recommendations Among Female Relatives of Breast Cancer Patients in Southwestern Nigeria
Actual Study Start Date :
Feb 13, 2017
Actual Primary Completion Date :
Oct 29, 2021
Actual Study Completion Date :
Oct 29, 2021

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Standard care (SC)

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
Experimental: SC + Risk assessment and counselling

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
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.
Other Names:
  • Risk assessment

    • Behavioral: Individualized breast cancer risk counselling
    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
    Other Names:
  • Counseling

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 [6 months]

      Questionnaire will be administered to the participants to determine the effects of the intervention on adherence to breast screening practices

    2. 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 [6 months]

      Questionnaire will be administered to the participants to determine the effects of the intervention on adherence to lifestyle risk reduction practices

    3. Predictors of BSE among first-degree female relatives of BC patients in South-West Nigeria [6 months]

      Statistical analysis will be carried out to determined the independent variables predicting BSE

    4. Predictors of time to first BC screening post-intervention among first-degree female relatives of BC patients in South-West Nigeria [Baseline]

      Statistical analysis will be carried out to determined the independent variables predicting first time to BC screening

    Secondary Outcome Measures

    1. Determine the perception of familial BC risk among first-degree female relatives of BC patients in South-West Nigeria. [Baseline]

      Semi-structured questionnaires will be used to determine the perception of familial BC risk among participants

    2. Determine the knowledge of familiar BC risk among first-degree female relatives of BC patients in South-West Nigeria. [Baseline]

      Semi-structured questionnaires will be used to determine the knowledge of familiar BC risk among participants

    3. 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]

      Semi-structured questionnaires will be used to determine the knowledge, attitude, and perception towards genetic testing and BC aetiology among participants

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 75 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Obafemi Awolowo University Teaching Hospital Complex (OAUTHC) Ile-Ife Osun Nigeria 5538
    2 University College Hospital (UCH) Ibadan Oyo Nigeria 200285
    3 Lagos State University Teaching Hospital (LASUTH) Lagos Nigeria 101233
    4 Lagos University Teaching Hospital (LUTH) Lagos Nigeria 102215

    Sponsors and Collaborators

    • University of Ibadan
    • Lagos State University Teaching Hospital (LASUTH)
    • Obafemi Awolowo University Teaching Hospital
    • Lagos University Teaching Hospital (LUTH)
    • University College Hospital, Ibadan

    Investigators

    • Principal Investigator: CELIA I AGWAI, MPH;PhD, University of Ibadan
    • Study Chair: Oladele O.O Kale, B.A (Dublin), M.B, B.Ch, B.A.O, University of Ibadan
    • Study Director: IkeOluwapo O. Ajayi, MBBS; PhD, University of Ibadan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Agwai Celia Imaria, Epidemiologist, University of Ibadan
    ClinicalTrials.gov Identifier:
    NCT05834933
    Other Study ID Numbers:
    • NHREC/05/01/2008a
    First Posted:
    Apr 28, 2023
    Last Update Posted:
    Apr 28, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Agwai Celia Imaria, Epidemiologist, University of Ibadan
    Breast cancer
    First-degree relatives
    Breast cancer prevention
    Risk assessment
    Risk counselling
    Southwest Nigeria
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Apr 28, 2023