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Multicenter randomized effectiveness/implementation trial of a digital self-management support tool to improve the quality of life during adjuvant hormonal therapy for patients with early breast cancer: The HOPE trial.

BACKGROUND: For patients with hormone receptor (HR) positive early breast cancer (BC), adjuvant endocrine therapy (ET) represents the cornerstone of treatment. However, 75% of patients experience ET-related symptoms that negatively affect their quality of life (QOL). Despite their high prevalence, these symptoms are often underestimated and under-addressed during consultations. As a result, non-adherence to ET is common and remains a major barrier for optimal disease and survival outcomes. METHODS: National, prospective, randomized, open-label hybrid type 1 effectiveness/implementation trial conducted in France comparing a personalized digital health pathway plus standard of care (SoC) vs. SoC alone in patients with HR+ early BC reporting ET-related symptoms. 180 patients will be randomized 1:1 to receive either 12 weeks of the digital health pathway or 12 weeks of SoC. The intervention is anchored by the Resilience© digital companion including remote symptom and needs assessment, an introductory nurse-navigator phone call, and access to personalized, symptom-specific online educational and self-management programs (physical activity, yoga, meditation or cognitive behavioral therapy). In both arms, patients will be invited to wear a wearable device to objectively monitor behavioral parameters. The primary endpoint is the ET symptoms scale of the European Organization for Research and Treatment of Cancer (EORTC) QLQ-BR45 over 12-weeks. Secondary endpoints include other QOL domains, self-reported ET adherence, eHealth literacy, self-efficacy, and evaluation of the implementation process. DISCUSSION: This study should provide evidence on the effectiveness and real-world implementation of a personalized digital health pathway to improve QOL in patients experiencing ET-related symptoms. TRIAL REGISTRATION: ClinicalTrials.gov NCT06781996; Protocol version 3.0.

Humans↗

[Undergraduate and graduate education in surgery].

In the world as well as in our country various branches of surgery have been developing at an unexpected rate over the past decades. Training and education of staff have been lagging behind, however, and there has been no parallel development of regulations concerning this field of education. This is partly due to inadequate cooperation and support od the part of professional organizations for surgery. As the highest professional and public body the Congress of Yugoslav Surgeons should take over the responsibility of analysing at each of its future conventions the state of education in the field of surgery in our country. These problems are not only local, regional and republic in nature but concern Yugoslavia as a whole. Under selfmanagement socialism the possibilities of self-management agreements and social compacts should therefore be employed to the utmost extent.

Education, Medical, Graduate↗

Differences in self-management behaviors and use of preventive services among diabetes management enrollees by race and ethnicity.

We assessed the degree that managed care organization (MCO) enrollees used preventive services and engaged in diabetes self-management behaviors by race/ethnicity. A 40-item selfadministered survey was mailed to 19,483 diabetic MCO enrollees. The survey measured use of eight preventive services and engagement in four self-management behaviors among enrollees who self-identified as black, white, or Hispanic. Of the 6,035 surveys analyzed, 4,623 respondents (76.6%) were white, 984 (16.3%) were black, and 428 (7.0%) were Hispanic. Black and Hispanic respondents reported more healthcare visits (mean of 7.0 and 6.5, respectively) in the past year compared to whites (mean, 5.7; p < 0.0001). However, compared to whites, blacks had significantly lower utilization of five of the eight preventive services measured, and Hispanics had significantly lower utilization of seven of the eight preventive services (p < 0.005). With regard to self-management behaviors, blacks were significantly less likely than whites to monitor their diet (65.9% vs. 73.7%, p < 0.0001), exercise (46.4% vs. 52.8%; p = 0.0004) and not smoke (85.1% vs. 89.3%; p = 0.0002); while Hispanics were less likely to monitor their diet (67.3% vs. 73.7%, p = 0.0051). All racial/ethnic groups had low levels of selfmanagement behaviors. Further research is warranted to identify why disparities remain in settings where services are universally available, and to find practical ways to eliminate disparities in a group with routine healthcare encounters.

Black or African American↗

Experience with INR self-management: patient selection and complication rates.

BACKGROUND: INR self-management can reduce the risk of complications for patients with indication of long-term oral anticoagulation therapy. However, little is known about early indicators of complication risk. METHODS: In a prospective study on 330 consecutive patients all participants were informed about oral anticoagulation by a structured teaching program. The two groups were divided as to whether they received usual medical care provided by a family physician (n=220) or self-management (n=110) on a portable coagulation monitor (CoaguChek System). After a mean follow up of 13.3+/-4.4 months, the participants of the study were interviewed by a structured questionnaire to obtain information about hemorrhagic and thromboembolic complications as well as survival. RESULTS: In comparison to patients under usual care, patients with INR selfmanagement were significantly younger (58 vs 64 years) and had fewer comorbidities (diabetes and hypertension) as well as a higher ejection fraction (53.6 vs 51.1%). Indication for anticoagulation, age and heart rhythm explained 58% of the differences between the management groups. There was no significant difference in the overall complication rates between the two groups (usual care vs selfmanagement): major bleeding 0.5 vs 0.9%, cerebral embolism (TIA or stroke) 1.9 vs 0.9%, hospital admission 2.3 vs 1.8%. A high BMI (OR=1.5; 95% CI 1.06-1.25; p=0.001) or a high therapeutic INR range (OR=2.42; 95% CI 1.16-5.1; p=0.019) is associated with a higher complication rate. CONCLUSIONS: Complication rates for patients with long-term oral anticoagulant therapy did not differ significantly between usual care and self-management. Rather, the patient's body weight and the requirement of high anticoagulation intensity drive the complication risk under both management systems.

Adult↗