Risk Reduction BehaviorNBCRSNCT05834933
Nigerian Breast Cancer Risk-Reduction Study
A study testing Individualized breast cancer risk assessment and Individualized breast cancer risk counselling in people with Risk Reduction Behavior and Breast Cancer, run by University of Ibadan at 4 sites in Nigeria.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Risk Reduction Behavior, Breast Cancer, Health Behavior
- What is being tested?
- Individualized breast cancer risk assessment and Individualized breast cancer risk counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 719 participants
- Where
- 4 sitesNigeria
- Study dates
- 13 Feb 2017to 29 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Personal history of BC
- Previous exposure to breast cancer risk assessment and counselling
- Absence of intact breasts
Trial locations and contacts
4 sites in 1 country.
Nigeria4 sites
University College Hospital (UCH)
Ibadan, Oyo State, 200285
Obafemi Awolowo University Teaching Hospital Complex (OAUTHC)
Ile-Ife, Osun State, 5538
Lagos State University Teaching Hospital (LASUTH)
Lagos, 101233
Lagos University Teaching Hospital (LUTH)
Lagos, 102215
About this 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
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?
Read more
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.
- Conditions
- Risk Reduction Behavior, Breast Cancer, Health Behavior, Health Care Utilization, Health Knowledge, Attitudes, Practice
- Being tested
- Individualized breast cancer risk assessment, Individualized breast cancer risk counselling
- Keywords
- Breast cancer, First-degree relatives, Breast cancer prevention, Risk assessment, Risk counselling, Southwest Nigeria
- Medical subject headings
- Risk Reduction Behavior, Breast Neoplasms, Health Behavior, Patient Acceptance of Health Care, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized breast cancer risk assessmentBehavioural
Also called 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.
Individualized breast cancer risk counsellingBehavioural
Also called Counseling
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
| Study group | Role | What they receive |
|---|---|---|
| Standard care (SC) | No intervention | 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 | 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 Receives: Behavioral: Individualized breast cancer risk assessment; Behavioral: Individualized breast cancer risk counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Questionnaire will be administered to the participants to determine the effects of the intervention on adherence to breast screening practices
Measured: 6 months
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
Questionnaire will be administered to the participants to determine the effects of the intervention on adherence to lifestyle risk reduction practices
Measured: 6 months
Predictors of BSE among first-degree female relatives of BC patients in South-West Nigeria
Statistical analysis will be carried out to determined the independent variables predicting BSE
Measured: 6 months
Predictors of time to first BC screening post-intervention among first-degree female relatives of BC patients in South-West Nigeria
Statistical analysis will be carried out to determined the independent variables predicting first time to BC screening
Measured: Baseline
Secondary outcomes (3)
Determine the perception of familial BC risk among first-degree female relatives of BC patients in South-West Nigeria.
Semi-structured questionnaires will be used to determine the perception of familial BC risk among participants
Measured: Baseline
Determine the knowledge of familiar BC risk among first-degree female relatives of BC patients in South-West Nigeria.
Semi-structured questionnaires will be used to determine the knowledge of familiar BC risk among participants
Measured: Baseline
Determine the knowledge, attitude, and perception towards genetic testing and BC aetiology among first-degree female relatives of BC patients in South-West Nigeria
Semi-structured questionnaires will be used to determine the knowledge, attitude, and perception towards genetic testing and BC aetiology among participants
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start13 Feb 2017
- Primary completion29 Oct 2021
- Study completion29 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk Reduction BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 719 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ibadan
- Sponsor type
- University, hospital or other
- Collaborators
- Lagos State University, Obafemi Awolowo University Teaching Hospital, Lagos University Teaching Hospital (LUTH), University College Hospital, Ibadan
- Responsible party
- Principal investigator, Agwai Celia Imaria, University of Ibadan
- Investigators
- OLADOSUN A OJENGBEDE, FMCOG, FWACS, FICS, M.B.B.S, Principal investigator, CENTER FOR POPULATION AND REPRODUCTIVE HEALTH (CPRH), UNIVERSITY COLLEGE HOSPITAL, IBADANOLADELE O.O KALE, B.A, M.B, B.Ch, B.A.O, Principal investigator, University of IbadanIKEOLUWAPO O. AJAYI, MBBS; PhD, Principal investigator, University of IbadanCELIA IMARIA AGWAI, M.P.H; Ph.D., Principal investigator, University of IbadanDEZHENG HUO, PhD, Study director, University of ChicagoOLUFUNMILAYO OLOPADE, M.D., F.A.C.P, Study chair, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834933
- Sponsor's protocol ID
- NHREC/05/01/2008a
- Acronym
- NBCRS
- Status last verified
- Aug 2023
- First submitted
- 5 Mar 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Risk Assessment and Counselling on Adherence to Risk Reduction Recommendations Among Female Relatives of Breast Cancer Patients in Southwestern Nigeria
- ClinicalTrials.gov ID
- NCT05834933
- Acronym / sponsor ID
- NBCRS / NHREC/05/01/2008a
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 719 participants (actual)
- Lead sponsor
- University of IbadanUniversity, hospital or other
- Collaborators
- Lagos State University, Obafemi Awolowo University Teaching Hospital, Lagos University Teaching Hospital (LUTH), University College Hospital, Ibadan
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 29 Oct 2021 (actual)
- Study completion
- 29 Oct 2021 (actual)
- First posted
- 28 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care (SC) | No intervention | –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 | Behavioral: Individualized breast cancer risk assessment, Behavioral: Individualized breast cancer risk counsellingParticipants 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 |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Personal history of BC
- Previous exposure to breast cancer risk assessment and counselling
- Absence of intact breasts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized breast cancer risk assessmentAlso: Risk assessmentIndividualized 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. | Behavioural | SC + Risk assessment and counselling |
| Individualized breast cancer risk counsellingAlso: CounselingIndividualized 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 | Behavioural | SC + Risk assessment and counselling |
Primary outcome
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
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
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
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
3 secondary outcomes
Determine the perception of familial BC risk among first-degree female relatives of BC patients in South-West Nigeria.
Time frame: Baseline
Determine the knowledge of familiar BC risk among first-degree female relatives of BC patients in South-West Nigeria.
Time frame: Baseline
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
OLADOSUN A OJENGBEDE, FMCOG, FWACS, FICS, M.B.B.S principal investigator
CENTER FOR POPULATION AND REPRODUCTIVE HEALTH (CPRH), UNIVERSITY COLLEGE HOSPITAL, IBADAN
OLADELE O.O KALE, B.A, M.B, B.Ch, B.A.O principal investigator
University of Ibadan
IKEOLUWAPO O. AJAYI, MBBS; PhD principal investigator
University of Ibadan
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized breast cancer risk assessment and Individualized breast cancer risk counselling in people with Risk Reduction Behavior and Breast Cancer, run by University of Ibadan at 4 sites in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023; AzTrials last refreshed its copy on 31 Oct 2026.