Approximately 53 million family caregivers (FCGs) support and provide home-based care for patients with chronic and life-limiting conditions. Caregiving at the end of life is an emotionally, cognitively and physically demanding role, and FCGs are often unpaid and receive little training. FCGs in remote, rural areas experience adverse social determinants of health (SDOHs), such as limited access to healthcare services and are often financially vulnerable, affecting their healthcare coverage, placing them at higher risk for poor emotional health. Adequate health literacy, a key SDOH, may be a protective factor. The purpose is to present the protocol of an explanatory sequential mixed-method study aiming to examine rural-dwelling FCGs’ emotional health, relationships among FCG characteristics (demographics, co-morbidities) and SDOH and health literacy as a potential mediator.
With 80% power to detect a mediation effect of at least 0.11 when the two-sided alpha is 0.05, an anticipated 108 adult rural FCGs who are providing palliative end-of-life care (PEOLC) will be recruited. Rigorous remote, digital- and community-based recruitment strategies will be employed to increase access to FCGs from under-represented rural communities. Self-report surveys include demographic and health characteristics, SDOH (health literacy, education level, employment status, annual income level, healthcare access and insurance) and anxiety/depressive symptoms. Descriptive statistics will be used to characterise the sample. Correlation analysis and one-way Analysis of variance (ANOVA) will be used to study the relationships between FCG characteristics, SDOH and anxiety/depressive symptoms. Hayes’ PROCESS Macro for IBM SPSS Statistics will be used to test mediation effects of health literacy between FCG characteristics/SDOH and anxiety/depressive symptoms. Indirect effects will be tested using bootstrapped CIs. Semistructured interviews will be conducted with a representative sample to elicit FCG perceptions relative to how SDOH affect their care provision and emotional health, then analysed using content analysis. Quantitative and qualitative strands will be examined and compared for convergence and divergence, then integrated for final interpretations.
Michigan State University’s Institutional Review Board has reviewed and approved the study. Written informed consent will be obtained from each participant. Study findings will be disseminated through publications in peer-reviewed journals and presentations at academic conferences.
Study outcomes will inform the role of SDOHs, particularly health literacy, for the development of interventions to emotionally support rural FCGs.
Despite the known haemostatic action of emicizumab (Hemlibra) in haemophilia A patients, its role in the prevention and control of bleeding in high-demand haemostatic situations, such as major surgery, remains to be determined. Patients receiving regular emicizumab prophylaxis often require concomitant factor VIII (FVIII) therapy during major surgery to prevent uncontrolled bleeding and to promote postoperative healing. However, there are limited prospective surgical data relating to concomitant FVIII and emicizumab use. Simoctocog alfa (Nuwiq) is a B-domain deleted recombinant FVIII produced in a human cell line without chemical modification or protein fusion with proven efficacy as surgical prophylaxis in adult and paediatric patients. The Nuwiq for Perioperative management Of patients With haemophilia A on Emicizumab Regular prophylaxis (NuPOWER) study aims to examine perioperative efficacy and safety of simoctocog alfa in haemophilia A patients on emicizumab prophylaxis undergoing major surgery.
NuPOWER is a prospective, open-label, single-arm, multicentre study that will be conducted at approximately 15 centres worldwide. Up to 28 male patients ≥12 years with severe haemophilia A and no FVIII inhibitors will be recruited. All patients must be receiving regular emicizumab prophylaxis and scheduled to undergo a major surgical procedure during which concomitant simoctocog alfa will be administered. The primary endpoint is the overall haemostatic efficacy of simoctocog alfa, adjudicated by an independent data monitoring committee using a pre-defined algorithm, and will consider intraoperative and postoperative efficacy assessments by the surgeon and investigator, respectively. Secondary endpoints include intraoperative haemostatic efficacy, postoperative haemostatic efficacy, number of allogeneic blood products transfused, perioperative FVIII plasma levels (as measured by FVIII activity) and thrombin generation, and safety parameters. In the era of non-factor therapy, NuPOWER will generate valuable prospective data on concomitant use of simoctocog alfa and emicizumab prophylaxis in patients with severe haemophilia A undergoing major surgery.
Ethical approval has been received from institutional review boards/independent ethics committees, and the study will be conducted in compliance with the Declaration of Helsinki. This work will be disseminated by publication of peer-reviewed manuscripts and presentations at scientific meetings.
CT EU 2022-502060-21-00; NCT05935358.
Timely diagnosis of breast cancer plays a vital role in improving treatment outcomes and increasing patient survival. However, contextual factors such as cultural beliefs, healthcare system structural limitations, and socioeconomic challenges can contribute to diagnostic delays. The qualitative study explores the barriers to timely diagnosis from the perspectives of Iranian women diagnosed with advanced breast cancer.
A qualitative study was conducted using in-depth, semistructured interviews to explore perceived barriers to timely diagnosis among Iranian women with advanced breast cancer. Data analysis were performed using MAXQDA software, V.20.
15 Iranian women [mean age 50.6±9.4 (range 38–72)] years with breast cancer diagnosed at an advanced stage.
Seven participants reported diagnostic delays that exceeded 7 months. Key factors contributing to perceived delays included poorly managed appointments and medical care, care not meeting patient expectations, deceptive marketing practices, cost of diagnostic procedures, lack of knowledge, fears, transcendent beliefs, competing priorities, insufficient support and diagnostic errors.
Understanding perceived barriers to timely diagnosis in women with advanced breast cancer is key to creating effective strategies that reduce preventable negative outcomes. Study findings have implications for patient education, healthcare quality, and enhancement of communication between providers and patients for delayed diagnosis prevention in respective treatment settings.