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非洲乳腺癌——结局差异(ABC-DO):撒哈拉以南非洲地区乳腺癌生存情况的多国家移动健康前瞻性研究方案

African Breast Cancer-Disparities in Outcomes (ABC-DO): protocol of a multicountry mobile health prospective study of breast cancer survival in sub-Saharan Africa.

作者信息

McKenzie Fiona, Zietsman Annelle, Galukande Moses, Anele Angelica, Adisa Charles, Cubasch Herbert, Parham Groesbeck, Anderson Benjamin O, Abedi-Ardekani Behnoush, Schuz Joachim, Dos Santos Silva Isabel, McCormack Valerie

机构信息

Section of Environment and Radiation, International Agency for Research on Cancer, Lyon, France.

Windhoek Central Hospital, Windhoek, Namibia.

出版信息

BMJ Open. 2016 Aug 23;6(8):e011390. doi: 10.1136/bmjopen-2016-011390.

Abstract

INTRODUCTION

Sub-Saharan African (SSA) women with breast cancer (BC) have low survival rates from this potentially treatable disease. An understanding of context-specific societal, health-systems and woman-level barriers to BC early detection, diagnosis and treatment are needed.

METHODS

The African Breast Cancer-Disparities in Outcomes (ABC-DO) is a prospective hospital-based study of overall survival, impact on quality of life (QOL) and delays along the journey to diagnosis and treatment of BC in SSA. ABC-DO is currently recruiting in Namibia, Nigeria, South Africa, Uganda and Zambia. Women aged 18 years or older who present at participating secondary and tertiary hospitals with a new clinical or histocytological diagnosis of primary BC are invited to participate. For consented women, tumour characteristics, specimen and treatment data are obtained. Over a 2-year enrolment period, we aim to recruit 2000 women who, in the first instance, will be followed for between 1 and 3 years. A face-to-face baseline interview obtains information on socioeconomic, cultural and demographic factors, QOL, health and BC attitudes/knowledge, and timing of all prediagnostic contacts with caregivers in orthodox health, traditional and spiritual systems. Responses are immediately captured on mobile devices that are fed into a tailored mobile health (mHealth) study management system. This system implements the study protocol, by prompting study researchers to phone women on her mobile phone every 3 months and, failing to reach her, prompts contact with her next-of-kin. At follow-up calls, women provide updated information on QOL, care received and disease impacts on family and working life; date of death is asked of her next-of-kin when relevant.

ETHICS AND DISSEMINATION

The study was approved by ethics committees of all involved institutions. All participants provide written informed consent. The findings from the study will be published in peer-reviewed scientific journals, presented to funders and relevant local organisations and at scientific conferences.

摘要

引言

撒哈拉以南非洲(SSA)地区的乳腺癌(BC)女性患者,对于这种本可治疗的疾病,其生存率较低。需要了解针对特定背景下影响乳腺癌早期检测、诊断和治疗的社会、卫生系统及女性层面的障碍。

方法

“非洲乳腺癌结局差异研究(ABC-DO)”是一项基于医院的前瞻性研究,旨在研究SSA地区乳腺癌患者的总生存率、对生活质量(QOL)的影响以及诊断和治疗过程中的延误情况。ABC-DO目前正在纳米比亚、尼日利亚、南非、乌干达和赞比亚招募患者。邀请年龄在18岁及以上、在参与研究的二级和三级医院初诊为原发性乳腺癌的新临床或组织细胞学诊断患者参与。对于同意参与的女性,获取肿瘤特征、标本和治疗数据。在为期2年的招募期内,我们的目标是招募2000名女性,首先对她们进行1至3年的随访。通过面对面的基线访谈,获取有关社会经济、文化和人口因素、生活质量、健康状况以及对乳腺癌的态度/知识,以及在正统医疗、传统和精神系统中与护理人员进行所有诊断前接触的时间等信息。这些回答会立即通过移动设备记录下来,并输入到定制的移动健康(mHealth)研究管理系统中。该系统通过每3个月提示研究人员给女性患者打电话来实施研究方案,如果未能联系到患者,则提示联系其近亲。在随访电话中,女性提供有关生活质量、所接受护理以及疾病对家庭和工作生活影响的最新信息;在相关情况下,向其近亲询问死亡日期。

伦理与传播

该研究已获得所有参与机构伦理委员会的批准。所有参与者均提供书面知情同意书。研究结果将发表在同行评审的科学期刊上,向资助者和相关当地组织汇报,并在科学会议上展示。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2839/5013398/53aeeff265cc/bmjopen2016011390f01.jpg

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