Dataset Information

Access to systemic anti-cancer therapies for women with secondary breast cancer-protocol for a mixed methods systematic review.

ABSTRACT:

Background

It is well recognised that access and receipt of appropriate guideline recommended treatment with systemic anti-cancer therapies for secondary breast cancer is a key determinant in overall survival. Where there is disparity in access this may result in unwarranted variation and disparity in outcomes. Individual, clinical and wider contextual factors have been associated with these disparities, however this remains poorly understood for women with secondary breast cancer. The purpose of the review is to examine individual, clinical and contextual factors which influence access to evidence-based systemic anti-cancer therapies for women with secondary breast cancer. This will include barriers and facilitators for access and receipt of treatment and an exploration of women and clinicians experience and perspectives on access.

Methods

A mixed methods approach with a segregated design will be used to examine and explore factors which influence access to systemic anti-cancer therapies for women with secondary breast cancer. Electronic databases to be searched from January 2000 onwards will be EBSCO CINAHL Plus, Ovid MEDLINE, Ovid EMBASE, PsychINFO and the Cochrane Library and JBI database. This will include NHS Evidence which will be searched for unpublished studies and gray literature. Title and abstract citations and full-text articles will be screened by the author and second reviewer. Data will be extracted by the author and validated by the second reviewer. An overarching synthesis will be produced which brings together quantitative and qualitative findings. Methodological quality and risk of bias will be assessed using the Mixed Methods Appraisal Tool.

Discussion

Understanding individual, clinical and wider contextual factors associated with access and receipt of systemic anti-cancer therapies for secondary breast cancer is a complex phenomenon. These will be examined to determine any association with access. Review findings will be used to guide future research in this area and the development of an evidence-based service level intervention designed to address unwarranted variation in access based upon the Medical Research Council (MRC) approach to the development, implementation and evaluation of complex interventions.

Systematic review registration

The review protocol has been registered in PROSPERO CRD42020196490 .

SUBMITTER: Pearson SA

PROVIDER: S-EPMC8299679 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BACKGROUND:Community-based health and social resources can help individuals with complex health and social needs achieve their health goals. However, there is often inadequate access to these resources due to a lack of physician and patient awareness of available resources and the presence of social barriers that limit an individual's ability to reach these services. Navigation services, where a person is tasked with helping connect patients to community resources, embedded within primary care may facilitate access and strengthen the continuity of care for patients. OBJECTIVE:This study aims to describe the protocol to assess whether the implementation of the Access to Resources in the Community (ARC) navigation model (an innovative approach to navigation services) is feasible, including its potential to achieve its intended outcomes, and to assess the viability of the evaluation approach. METHODS:The study consists of a single-arm, prospective, explanatory, mixed-methods, pre-post design feasibility study focusing on primary care practice settings with vulnerable populations. Participants include primary care providers and patients. RESULTS:Enrollment is closed with 82 patients. Navigation services have ended for 69 patients. CONCLUSIONS:The study of an innovative complex intervention requires an adequate assessment of the feasibility of the intended approach during which the potential challenges of the planned intervention and need for its adaptation may be uncovered. Undertaking a feasibility study of the ARC navigation model from a conceptually clear and methodologically solid protocol will inform on the practicality and acceptability of the approach, demand for the services, ease of implementation, quality of integration of the new services within primary care, and practicality and potential for efficacy prior to initiating a randomized controlled trial. TRIAL REGISTRATION:ClinicalTrials.gov NCT03105635; https://clinicaltrials.gov/ct2/show/NCT03105635 (Archived by WebCite at hhttp://www.webcitation.org/75FrwXORl). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):RR1-10.2196/11022.

Project description:BackgroundThe increasing emphasis to share patient data from clinical research has resulted in substantial investments in data repositories and infrastructure. However, it is unclear how shared data are used and whether anticipated benefits are being realized.ObjectiveThe purpose of our study is to examine the current utilization of shared clinical research data sets and assess the effects on both scientific research and public health outcomes. Additionally, the study seeks to identify the factors that hinder or facilitate the ethical and efficient use of existing data based on the perspectives of data users.MethodsThe study will utilize a mixed methods design, incorporating a cross-sectional survey and in-depth interviews. The survey will involve at least 400 clinical researchers, while the in-depth interviews will include 20 to 40 participants who have utilized data from repositories or institutional data access committees. The survey will target a global sample, while the in-depth interviews will focus on individuals who have used data collected from low- and middle-income countries. Quantitative data will be summarized by using descriptive statistics, while multivariable analyses will be used to assess the relationships between variables. Qualitative data will be analyzed through thematic analysis, and the findings will be reported in accordance with the COREQ (Consolidated Criteria for Reporting Qualitative Research) guidelines. The study received ethical approval from the Oxford Tropical Research Ethics Committee in 2020 (reference number: 568-20).ResultsThe results of the analysis, including both quantitative data and qualitative data, will be available in 2023.ConclusionsThe outcomes of our study will offer crucial understanding into the current status of data reuse in clinical research, serving as a basis for guiding future endeavors to enhance the utilization of shared data for the betterment of public health outcomes and for scientific progress.Trial registrationThai Clinical Trials Registry TCTR20210301006; https://tinyurl.com/2p9atzhr.International registered report identifier (irrid)DERR1-10.2196/44875.

Project description:IntroductionViolence against women is a public health problem that poses serious consequences for victims and their environments. The healthcare system struggles to assess this phenomenon during prenatal and postpartum care because of pregnant and postpartum women's potential vulnerabilities. The research protocol presents the aims to evaluate the prevalence of violence, the period(s) in which it occurs, aggressors and forms it takes as well as to explore how violence against women is perceived among pregnant and postpartum women.Methods and analysisThis mixed methods study protocol uses an explanatory sequential design and is based on the establishment of meta-inferences that result from the combination of quantitative and qualitative approaches. Probabilistic sampling will be used to select the study participants: 584 women attending prenatal and/or postpartum care outpatient services at the University of Campinas Women's Hospital, Brazil. The quantitative approach will consist of four validated questionnaires, and the qualitative approach will use focus groups that serve to deepen the understanding of participants' views about the study topic. To create the focus groups, 72 study participants will be invited and divided into 6 groups (3 adolescents and 3 adults) based on age and pregnancy/postpartum condition. Descriptive analysis of sociodemographic characteristics and questionnaire results will be used to identify the prevalence and forms of violence experienced by women during the pregnancy-puerperal cycle, the relationships between women and their aggressors, and the existence of a history of violence. A bivariate and multivariate analysis will be performed to identify the association between sociodemographic factors and violence as an outcome. Qualitative data will be analysed through Grounded Theory to understand women's perceptions of the phenomenon studied.Ethics and disseminationThe research protocol was approved by the Research Ethics Committee of the University of Campinas, Brazil number CAAE: 13426819.1.0000.5404. The results will be disseminated to the health science community.

Project description:BackgroundDeaf American Sign Language (ASL) users often struggle with limited health literacy compared with their hearing peers. However, the mechanisms driving limited health literacy and how this may impact access to and understanding of health information for Deaf individuals have not been determined. Deaf individuals are more likely than hearing individuals to use the internet, yet they continue to report significant barriers to health information. This study presents an opportunity to identify key targets that impact information access for a largely marginalized population.ObjectiveThis study aims to elucidate the role of information marginalization on health literacy in Deaf ASL users and to better understand the mechanisms of health literacy in this population for the purpose of identifying viable targets for future health literacy interventions.MethodsThis is an exploratory mixed methods study to identify predictors and moderators of health literacy in the Deaf population. These predictors of health literacy will be used to inform the second step that qualitatively explains the findings, including how Deaf individuals access and understand Web-based health information. Multiple interviewer- and computer-based instruments underwent translation and adaptation, from English to ASL, to make them accessible for the Deaf participants in our study. A planned sample of 450 Deaf ASL users and 450 hearing native English speakers, aged 18 to 70 years, will be recruited from 3 partnering sites: Rochester, NY; Flint, MI; and Chicago, IL. These individuals will participate in a single data collection visit. A subset of participants (approximately 30) with key characteristics of interest will be invited for a second data collection visit to observe and inquire more about their ability to directly access, navigate, and comprehend Web-based health information. The study will help assess how the ways health literacy and information are visualized may differ between Deaf individuals and hearing individuals. The study will also survey participants' ownership and use of computer and mobile devices and their level of Web-based information use, including health information.ResultsAdaptation and translation of protocols and instruments have been completed and are now in use for the study. Recruitment is underway and will continue until late 2020. Results from this study will be used to provide a guide on how to structure Web-based health information in a way that maximizes accessibility and improves health literacy for Deaf individuals.ConclusionsThe results from this mixed methods proposal will advance what is known about health literacy and health information accessibility for Deaf individuals. This innovative study will generate rich data on how to formulate health information and health literacy interventions more accurately to take advantage of visual learning skills.International registered report identifier (irrid)PRR1-10.2196/14889.

Project description:IntroductionBiological and precision therapies are increasingly used in cancer treatment. Although they may improve survival, they are also associated with various-and unique-adverse effects, which can be long lasting. Little is known about the experiences of people treated with these therapies. Moreover, their supportive care needs have not been fully explored. Consequently, it is unclear whether existing instruments adequately capture the unmet needs of these patients. The TARGET study seeks to address these evidence gaps by exploring the needs of people treated with these therapies with the aim of developing an unmet needs assessment instrument for patients on biological and precision therapies.Methods and analysisThe TARGET study will adopt a multi-methods design involving four Workstreams (1) a systematic review to identify, describe and assess existing unmet needs instruments in advanced cancer; (2) qualitative interviews with patients on biological and precision therapies, and their healthcare professionals, to explore experiences and care needs; (3) development and piloting of a new (or adapted) unmet needs questionnaire (based on the findings of Workstream 1 and Workstream 2) designed to capture the supportive care needs of these patients; and finally, (4) a large-scale patient survey using the new (or modified) questionnaire to determine (a) the psychometric properties of the questionnaire, and (b) the prevalence of unmet needs in these patients. Based on the broad activity of biological and precision therapies, the following cancers will be included: breast, lung, ovarian, colorectal, renal and malignant melanoma.Ethics and disseminationThis study was approved by National Health Service (NHS) Heath Research Authority Northeast Tyne and Wear South Research Ethics Committee (REC ref: 21/NE/0028). Dissemination of the research findings will take several formats to reach different audiences, including patients, healthcare professionals and researchers.

Project description:IntroductionIn January 2017, mifepristone-induced medical abortion was made available in Canada. In this study, we will seek to (1) understand facilitators and barriers to the implementation of mifepristone across Canada, (2) assess the impact of a 'community of practice' clinical and health service support platform and (3) engage in and assess the impact of integrated knowledge translation (iKT) activities aimed to improve health policy, systems and service delivery issues to enhance patient access to mifepristone.Methods and analysisThis prospective mixed-methods implementation study will involve a national sample of physicians and pharmacists recruited via an online training programme, professional networks and a purpose-built community of practice website. Surveys that explore constructs related to diffusion of innovation and Godin's behaviour change frameworks will be conducted at baseline and at 6 months, and qualitative data will be collected from electronic interactions on the website. Survey participants and a purposeful sample of decision-makers will be invited to participate in in-depth interviews. Descriptive analyses will be conducted for quantitative data. Thematic analysis guided by the theoretical frameworks will guide interpretation of qualitative data. We will conduct and assess iKT activities involving Canada's leading health system and health professional leaders, including evidence briefs, Geographical Information System (GIS)maps, face-to-face meetings and regular electronic exchanges. Findings will contribute to understanding the mechanisms of iKT relationships and activities that have a meaningful effect on uptake of evidence into policy and practice.Ethics and disseminationEthical approval was received from the University of British Columbia Children's and Women's Hospital Ethics Review Board (H16-01006). Full publication of the work will be sought in an international peer-reviewed journal. Findings will be disseminated to research participants through newsletters and media interviews, and to policy-makers through invited evidence briefs and face-to-face presentations.

Project description:IntroductionAfrican American women (AA), particularly those living in the Southeastern USA, experience disproportionately high rates of HIV infection. Pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention tool that may circumvent barriers to traditional HIV prevention tools, such as condom use; however, very little is known about how to improve PrEP access and uptake among AA women who may benefit from PrEP use. This project aims to understand how to increase PrEP access among AA women in the rural Southern USA, which may ultimately affect HIV incidence in this population.Methods and analysisThe goal of the current study is to systematically adapt a patient-provider communication tool to increase PrEP uptake among AA women receiving care at a federally qualified health centre in Alabama. We will use an iterative implementation process, by assessing the feasibility, acceptability and preliminary impact of the tool on PrEP uptake, using a pilot preintervention/postintervention design (N=125). We will evaluate women's reasons for declining a referral to a PrEP provider, reasons for incomplete referrals, reasons for not initiating PrEP after a successful referral and ongoing PrEP use at 3 and 12 months after PrEP initiation among our sample. The proposed work will significantly contribute to our understanding of factors impacting PrEP uptake and use among AA women, particularly in underserved areas in the Deep South that are heavily impacted by the HIV epidemic and experience worse HIV-related health outcomes relative to other areas in the USA.Ethics and disseminationThis protocol has been approved by the Institutional Review Board (IRB) at University of Alabama at Birmingham (Birmingham, AL; protocol 300004276). All participants will review a detailed informed consent form approved by the IRB and will provide written or verbal informed consent prior to enrolment. Results will be disseminated through peer-reviewed manuscripts, reports, and local, national and international presentations.Trial registration numberNCT04373551.