Nigerian Breast Cancer Risk-Reduction Study (NBCRS)

University of Ibadan

Status: Completed

Conditions: Breast Cancer; Risk Reduction Behavior; Health Behavior; Health Knowledge, Attitudes, Practice; Health Care Utilization

Treatments: Behavioral: Individualized breast cancer risk counselling; Behavioral: Individualized breast cancer risk assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT05834933

NHREC/05/01/2008a (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 719 patients

Sex: Female

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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719 participants in 2 patient groups

Standard care (SC)

No Intervention group

Description:

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

SC + Risk assessment and counselling

Experimental group

Description:

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

Treatment:

Behavioral: Individualized breast cancer risk assessment

Behavioral: Individualized breast cancer risk counselling