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临床试验/NCT05321823
NCT05321823Unknown不适用

Improving Access to Breast Cancer Screening and Treatment in Nigeria: The Triple Mobile Assessment and Patient Navigation Model

Obafemi Awolowo University2 个研究点 分布在 1 个国家目标入组 4,100 人开始时间: 2021年12月8日最近更新:
适应症

试验速览

阶段
不适用
入组人数
4,100
试验地点
2
主要终点
Timeline from presentation to treatment

研究概览

简要总结

The goal of this study is to establish a novel community-based breast cancer program to address delayed presentation and lack of access to diagnostic and treatment facilities in South-West Nigeria. It is aimed at evaluating the impact of a novel breast cancer early detection program using triple mobile assessment (innovative handheld iBreast Exam [iBE] device, mobile ultrasound, and mobile mammography) and patient navigation program in a Nigerian community.

详细描述

This study aims to provide screening to asymptomatic women 40-70 years and to provide diagnostic evaluation to women 30-70 years presenting with breast symptoms in a community in South-West Nigeria.

The project will use a cluster randomized design with 1 community serving as the intervention arm and another community serving as the control arm. Both communities will receive breast cancer awareness and education but only the intervention community will receive screening, mobile imaging and navigation. Screening with targeted clinical history, Clinical Breast Exam (CBE), and iBE will be performed by trained Community Health Nurses in the intervention community. Women with positive CBE or iBE findings will undergo breast imaging with mobile mammography and portable ultrasound, as well as biopsy when indicated by the Radiologist who visits the community once a month, and receive navigation by the nurses to the point of care. The control population will receive breast cancer awareness without an organized screening, imaging or navigation program. Women presenting to the Primary Health Care Centers in the control community will be referred to the Teaching Hospital as per current standard of care. Record of all breast cancer cases seen in the 2 communities during the study period will be obtained.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
30 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Asymptomatic women 40 - 70 years
  • Symptomatic women (with breast-related symptoms) 30 - 70 years

排除标准

  • Male subjects
  • Women living outside the study locations (Ife East and Ife North districts)

结局指标

主要结局

Timeline from presentation to treatment

时间窗: After year 1 of the 2-year study period

Time interval between presentation for screening in the community and treatment in the tertiary hospital

Participation rate

时间窗: After year 1 of the 2-year study period

Percentage of women screened of the total number of eligible women in each community.

Abnormal call rate

时间窗: After year 1 of the 2-year study period

Number of women with abnormalities detected on iBE and/or CBE requiring further evaluation either by imaging or biopsy out of the total number of women screened.

Breast cancer detection rate

时间窗: After year 1 of the 2-year study period

Number of histologically diagnosed cases of breast cancer per 1,000 screened populations.

Stage at presentation

时间窗: After year 1 of the 2-year study period

The tumour, node and metastasis (TNM) stage among those with histologically confirmed breast cancer.

Retention rate

时间窗: After year 2 of the 2-year study period

Number of women who return for repeat annual screening of the total initial number of women screened.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adeleye Omisore

Dr.

Obafemi Awolowo University

研究点 (2)

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