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Completed

NCT Number: NCT05834933

Nigerian Breast Cancer Risk-Reduction Study

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.

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Key information

Age range

20 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Obafemi Awolowo University Teaching Hospital Complex (OAUTHC), Ile-Ife, Osun State, Nigeria

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Personal history of BC
  • Previous exposure to breast cancer risk assessment and counselling
  • Absence of intact breasts

Treatment and study plan

Individualized breast cancer risk assessment

Behavioral

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

Individualized breast cancer risk counselling

Behavioral

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

Primary outcomes

  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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Baseline

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

Secondary outcomes

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

    Time frame: 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.

    Time frame: 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

    Time frame: Baseline

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

Sponsors and collaborators

Lead sponsor

University of Ibadan

Other

Collaborators

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

Registry information

Official study title

Effects of Risk Assessment and Counselling on Adherence to Risk Reduction Recommendations Among Female Relatives of Breast Cancer Patients in Southwestern Nigeria

Acronym: NBCRS

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Apr 28, 2023
Registry last updated
Aug 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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