Diferencias entre los cánceres de mama diagnosticados clínicamente y los detectados en un programa de cribado

OBJETIVOS: El objetivo principal fue determinar si los cánceres de mamadiagnosticados clínicamente tenían características histológicas y biológicasdiferentes a los que se diagnostican en un programa de cribado. Los objetivossecundarios fueron comparar los factores de riesgo y el tratamiento recibido porlas pacientes diagnosticadas a partir de un programa de cribado y lasdiagnosticadas clínicamente.METODOLOGÍA: Estudio de casos y controles. Se incluyeron 311 pacientescon diagnóstico histológico de cáncer de mama y edad entre 45 y 65 años que setrataron en el Servicio de Oncología Médica del Hospital Universitario La Fe deValencia entre 1999 y 2003. En función del método de diagnóstico (cribado oclínico) se establecieron 2 grupos: grupo de diagnóstico precoz donde seincluyeron 158 pacientes (DP) y grupo de diagnóstico clínico (DC) donde seincluyeron 153 pacientes.RESULTADOS: Las pacientes diagnosticadas en el grupo de cribado teníanmayor porcentaje de carcinomas in situ (DP 9.5%, DC 2.62), tumores invasivosmenores de 10 mm (DP 25.9%, DC 8.1%), menor porcentaje de afectaciónganglionar axilar (DP 75.9%, DC 55.6%) y tumores más diferenciados (DP38%, DC 24.8%). Las pacientes del grupo de diagnóstico precoz tenían mayorporcentaje de receptores de estrógeno (DP 87.3%, DC 79.1%), progesterona (DP84.3%, DC 76.7%) y de expresión de bcl2 (DP 75.3%, DC 62.9%). Laspacientes procedentes del cribado se trataron más con cirugía conservadora (DP83.2%, 62.5%) y hormonoterapia (DP 92.3%, DC 82.9%) y menosquimioterapia (DP 44.3%, DC 78.4%).CONCLUSIONES: Las pacientes de DP tienen mayor porcentaje de carcinomasno invasores Los carcinomas invasores en este grupo son de menor tamaño ytienen menos afectación de los ganglios axilares. Los tumores diagnosticados enel grupo de DP tienen menor agresividad que los tumores diagnosticados en elde DC (grado histológico, receptor de estrógeno y progesterona, expresión debcl2). El cribado mamográfico permite utilizar tratamientos quirúrgicos menosagresivos y menos tratamiento adyuvante con quimioterapia sistémica, no asícon hormonoterapia.OBJECTIVES: The aim of the study was to compare the histological andbiological features of breast cancers diagnosed with screening and clinically.METHODS: The study considers 311 patients with breast cancers between 45and 65 treated in the Oncology Department of Hospital Universitario La Fe inValencia (Spain) between 1999 and 2003. They were divided in two groups onthe basis of the diagnosis method: screening group (DP) with 158 patients andclinical group (DC) with 153 patients.RESULTS: The patients in group of DP had many carcinomas in situ (DP 9.5%,DC 2.62), invasive tumours less than 10 mm (DP 25.9%, DC 8.1%), lesspositive nodes (DP 75.9%, DC 55.6%) and lower histological grades (DP 38%,DC 24.8%). The patients in group of DP had higher percentaje of estrogenreceptors (DP 87.3%, DC 79.1%), progesteron receptors (DP 84.3%, DC 76.7%)and bcl2 expresion (DP 75.3%, DC 62.9%). The patients in group of DP weretreated with conservative surgery in many cases (DP 83.2%, 62.5%) andadjuvant hormonal treatment (DP 92.3%, DC 82.9%) but they received lesschemotherapy (DP 44.3%, DC 78.4%).CONCLUSIONS: patients with breast cancer in the DP goup have morecarcinoma in situ, smaller invasive tumours and less positive nodes.Screeningtumours have higher expression of estrogen and progesteron receptors and bcl 2.Patients in the DP group have been treated with more conservative surgery andadjuvant hormonal therapy but less chemotherapy

Mujeres con cáncer de mama: evaluación del afecto positivo y negativo y valoración de un programa de Intervención psicológica en el ámbito hospitalario

[email protected] la actualidad hay numerosos estudios que demuestran que la intervención psicológica es benefi ciosa para los pacientes con cáncer. Nuestro objetivo es investigar el efecto intra- sujetos de la intervención psicológica sobre el afecto positivo y negativo durante los ciclos de tratamiento de quimioterapia adyuvante en mujeres con cáncer de mama. Además estudiamos el efecto de la interacción entre la psicoterapia y la resistencia/vulnerabilidad psicológica de las pacientes en las mismas variables dependientes. Método: La muestra está formada por 119 pacientes diagnosticadas de un cáncer de mama localizado que recibieron tratamiento adyuvante con quimioterapia. Todas las pacientes fueron evaluadas y recibieron intervención psicológica a lo largo del tratamiento. Las variables dependientes: el afecto positivo y negativo fueron evaluadas en cinco intervalos: previamente al tratamiento quimioterápico, 2º, 4º, 6º ciclo de quimioterapia y a los dos meses post-tratamiento. El factor entresujetos resistencia/vulnerabilidad psicológica se derivó de un Análisis de Cluster a partir de cuatro medidas, pre y post, de ansiedad y depresión. Los instrumentos de evaluación utilizados fueron la Escala de Afecto Positivo y Negativo (Sánchez-Cánovas, 1994), y la Escala Hospitalaria de Ansiedad y Depresión (HADS) de Zigmond y Snaith (1983). Se realizó análisis descriptivo de los datos, Análisis Múltiple de la Varianza (MANOVA) de medias repetidas para la comparación intra-sujetos y el diseño factorial mixto para la comparación entre-sujetos (resistentes /vulnerables) Resultados: muestran el efecto principal intra-sujetos de la intervención psicológica en el afecto positivo (p<0.05), no existiendo efecto de la interacción entre la intervención psicológica y la resistencia/vulnerabilidad psicológica. Respecto del afecto negativo, el efecto de la intervención psicológica intra-sujetos y la interacción de ésta con los grupos de pacientes resistentes/vulnerables es signifi cativo en ambos casos (p<0.05). Los contrastes intrasujetos entre los 5 intervalos muestran diferencias signifi cativas entre el intervalo del pretratamiento (1ª evaluación) y el 2º ciclo de quimioterapia (2ª evaluación) en el afecto positivo y negativo. Conclusiones: La ganancia más importante se obtiene en la primera intervención psicológica y ésta es crucial para el mantenimiento del estado de ánimo positivo y la disminución del afecto negativo de las pacientes. Hay ganancia en los dos grupos, las pacientes vulnerables son las que más mejoría experimentan. Es importante señalar la importancia de esta primera intervención y la repercusión que tiene frente a las contingencias aversivas que supone los sucesivos ciclos de quimioterapia.Currently there are numerous publications demonstrating that psychological intervention in patients with cancer is benefi cial. Our objective is to study the within-subjects effect of the psychological intervention on the positive and negative affect during adjuvant chemotherapy cycles in women with breast cancer. In addition, we study the effect of the interaction between psychotherapy and psychological resistance/ vulnerability of patients on the same dependent variables. Method: The sample consists of 119 patients diagnosed with a localized breast cancer that received adjuvant chemotherapy treatment. All the patients were evaluated and received psychological intervention throughout the treatment. Dependent variables: positive and negative affect were evaluated in fi ve intervals: chemotherapy pre-treatment, second, fourth, sixth cycle of chemotherapy and two month post-treatment. The two groups of resistant and vulnerable patients were divided by Cluster Analysis of two measures of anxiety and depression before and after of chemotherapy. Measures used were the Positive and Negative Affect Scale (Sánchez- Cánovas, 1994) and the Hospital Anxiety and Depression Scale (HADS) of Zigmond and Snaith (1983). Descriptive analysis of data and a multivariate analysis of variance with repeated-measures (MANOVA-RM) were performed to compare within-subjects and the mixed factorial design to compare betweensubjects (resistant/vulnerable). Results: demonstrate the main within-subjects effect of the psychological intervention in the positive affect (p<0.05), existing no effect between psychological intervention and psychological resistance /vulnerability interaction. In relation to the negative affect, the effect of the within-subjects psychological intervention and its interaction with the resistant/vulnerable group of patients is signifi cant in both cases (p<0.05). Within-subjects contrasts among the fi ve intervals show signifi cant differences between the pre-treatment interval (fi rst evaluation) and the second cycle of chemotherapy (second evaluation) in the negative and positive affect. Conclusions: The most important benefi t is obtained in the fi rst psychological intervention which is crucial to maintain a positive mood state and diminish the negative affect of patients. There is benefi t in both groups; however, the vulnerable patients present more improvement. Moreover, it is worth mentioning the importance of this fi rst intervention and its repercussion in response to aversive contingencies of chemotherapy cycles

Women with breast cancer: positive and negative affect assessment and psychological intervention program in the hospital area

En la actualidad hay numerosos estudios que demuestran que la intervención psicológica es beneficiosa para los pacientes con cáncer. Nuestro objetivo es investigar el efecto intra-sujetos de la intervención psicológica sobre el afecto positivo y negativo durante los ciclos de tratamiento de quimioterapia adyuvante en mujeres con cáncer de mama. Además estudiamos el efecto de la interacción entre la psicoterapia y la resistencia/vulnerabilidad psicológica de las pacientes en las mismas variables dependientes. Método: La muestra está formada por 119 pacientes diagnosticadas de un cáncer de mama localizado que recibieron tratamiento adyuvante con quimioterapia. Todas las pacientes fueron evaluadas y recibieron intervención psicológica a lo largo del tratamiento. Las variables dependientes: el afecto positivo y negativo fueron evaluadas en cinco intervalos: previamente al tratamiento quimioterápico, 2º, 4º, 6º ciclo de quimioterapia y a los dos meses post-tratamiento. El factor entresujetos resistencia/vulnerabilidad psicológica se derivó de un Análisis de Cluster a partir de cuatro medidas, pre y post, de ansiedad y depresión. Los instrumentos de evaluación utilizados fueron la Escala de Afecto Positivo y Negativo (Sánchez-Cánovas, 1994), y la Escala Hospitalaria de Ansiedad y Depresión (HADS) de Zigmond y Snaith (1983). Se realizó análisis descriptivo de los datos, Análisis Múltiple de la Varianza (MANOVA) de medias repetidas para la comparación intra-sujetos y el diseño factorial mixto para la comparación entre-sujetos (resistentes /vulnerables) Resultados: muestran el efecto principal intra-sujetos de la intervención psicológica en el afecto positivo (p&lt;0.05), no existiendo efecto de la interacción entre la intervención psicológica y la resistencia/vulnerabilidad psicológica. Respecto del afecto negativo, el efecto de la intervención psicológica intra-sujetos y la interacción de ésta con los grupos de pacientes resistentes/vulnerables es significativo en ambos casos (p&lt;0.05). Los contrastes intra-sujetos entre los 5 intervalos muestran diferencias significativas entre el intervalo del pre-tratamiento (1ª evaluación) y el 2º ciclo de quimioterapia (2ª evaluación) en el afecto positivo y negativo. Conclusiones: La ganancia más importante se obtiene en la primera intervención psicológica y ésta es crucial para el mantenimiento del estado de ánimo positivo y la disminución del afecto negativo de las pacientes. Hay ganancia en los dos grupos, las pacientes vulnerables son las que más mejoría experimentan. Es importante señalar la importancia de esta primera intervención y la repercusión que tiene frente a las contingencias aversivas que supone los sucesivos ciclos de quimioterapia.Currently there are numerous publications demonstrating that psychological intervention in patients with cancer is beneficial. Our objective is to study the within-subjects effect of the psychological intervention on the positive and negative affect during adjuvant chemotherapy cycles in women with breast cancer. In addition, we study the effect of the interaction between psychotherapy and psychological resistance/ vulnerability of patients on the same dependent variables. Method: The sample consists of 119 patients diagnosed with a localized breast cancer that received adjuvant chemotherapy treatment. All the patients were evaluated and received psychological intervention throughout the treatment. Dependent variables: positive and negative affect were evaluated in five intervals: chemotherapy pre-treatment, second, fourth, sixth cycle of chemotherapy and two-month post-treatment. The two groups of resistant and vulnerable patients were divided by Cluster Analysis of two measures of anxiety and depression before and after of chemotherapy. Measures used were the Positive and Negative Affect Scale (Sánchez-Cánovas, 1994) and the Hospital Anxiety and Depression Scale (HADS) of Zigmond and Snaith (1983). Descriptive analysis of data and a multivariate analysis of variance with repeated-measures (MANOVA-RM) were performed to compare within-subjects and the mixed factorial design to compare betweensubjects (resistant/vulnerable). Results: demonstrate the main within-subjects effect of the psychological intervention in the positive affect (p&lt;0.05), existing no effect between psychological intervention and psychological resistance /vulnerability interaction. In relation to the negative affect, the effect of the within-subjects psychological intervention and its interaction with the resistant/vulnerable group of patients is significant in both cases (p&lt;0.05). Within-subjects contrasts among the five intervals show significant differences between the pre-treatment interval (first evaluation) and the second cycle of chemotherapy (second evaluation) in the negative and positive affect. Conclusions: The most important benefit is obtained in the first psychological intervention which is crucial to maintain a positive mood state and diminish the negative affect of patients. There is benefit in both groups; however, the vulnerable patients present more improvement. Moreover, it is worth mentioning the importance of this first intervention and its repercussion in response to aversive contingencies of chemotherapy cycles

The prognostic significance of tumor-infiltrating lymphocytes, PD-L1, BRCA mutation status and tumor mutational burden in early-stage high-grade serous ovarian carcinoma. A study by the Spanish Group for Ovarian Cancer Research (GEICO)

Early stages are under-represented in studies on the molecular and immune features of high-grade serous ovarian carcinoma (HGSOC), and specific studies focused on early-stage HGSOC are required for a better prognostic stratification and to personalize chemotherapy. The aim of this study was to determine the prognostic significance of CD8+ and CD4+ tumor-infiltrating lymphocytes (TILs), tumoral cell PD-L1 expression, BRCA mutational status and tumor mutation burden (TMB) in early-stage HGSOC. A retrospective study was performed on stage I and II HGSOC from the Molecular Reclassification of Early Stages of Ovarian Cancer (RECLAMO) cohort from the Spanish Group of Ovarian Cancer Research (GEICO). Centralized histological typing was performed based on morphological and immunohistochemical features. Intraepithelial (i) and stromal (s) CD8+ and CD4+ T cells and PD-L1 were evaluated on tissue microarrays by immunohistochemistry. BRCA1 and BRCA2 mutation status and TMB were analyzed in tumor DNA using next-generation sequencing. The study included 124 tumors. High iCD8+ (>20 TILs/core), low/intermediate CD4+ (35/core) were associated with favorable outcomes. Tumor cell PD-L1 expression (TPS ≥ 1) was present in only 8% of tumors. In total, 11 (16%) and 6 (9%) out of 69 HGSOC tested carried pathogenic or likely pathogenic BRCA1 or BRCA2 mutations, respectively. Median TMB of 40 tumors analyzed was 5.04 mutations/Mb and only 6 tumors had 10 or more mutations/Mb. BRCA status and TMB were not associated with TILs or prognosis. When compared with studies on advanced HGSOC, our results suggested that prognostic variables differed according to stage and that more studies focused on early stages of HGSOC are needed to better stratify these tumors: This work was supported by Instituto de Salud Carlos III (ISCIII) (grants PI19/01331, PI22/01892 and PMP22/00054); CIBERONC (grant CB16/12/00316); European Development Re gional Fund ‘A way to achieve Europe’ (FEDER), Spanish Group of Research in Ovarian Cancer (GEICO group); and by the Spanish Association Against Cancer Scientific Foundation (AECC)

Efficacy and safety of trabectedin in metastatic uterine leiomyosarcoma: A retrospective multicenter study of the Spanish ovarian cancer research group (GEICO)

Objective: We assessed trabectedin in patients with advanced uterine leiomyosarcoma (uLMS) in real-life clinical practice given according to the marketing authorization. Methods: Thirty-six women from 11 tertiary hospitals across Spain who received trabectedin after anthracyclinecontaining regimen/s were retrospectively analyzed. The primary endpoint was progression-free survival (PFS). Results: Median PFS and overall survival (OS) since starting trabectedin treatment were 5.4 (95%CI: 3.5–7.3) and 18.5 months (95%CI: 11.5–25.6), respectively. Median OS was significantly higher (P = 0.028) in patients receiving trabectedin in ≤ 2nd line (25.3 months) than in ≥ 3rd (15.1 months) and with ECOG performance status ≤ 1 at trabectedin start (19.8 months) than ECOG 2–3 (6.0 months, P = 0.013). When calculating OS since diagnosis, patients had longer OS with localized disease at diagnosis (87.4 months) vs. locally advanced (30.0 months) or metastatic (44.0 months, P = 0.041); and patients who received adjuvant therapy (87.4 months) compared with those who did not (30.0 months, P = 0.003), especially when receiving radiochemotherapy (106.7 months, P = 0.027). One patient (2.8%) had a complete response (CR) and nine patients (25.0%) achieved a partial response (PR) for an objective response rate of 27.8% with median response duration of 11 months (range: 4–93). Eighteen patients (50.0%) had disease stabilization for a disease control rate (DCR) of 77.8%. More patients receiving trabectedin in 1st-line of advanced disease achieved CR (16.7%) and PR (50.0%) than those in ≥ 2nd line/s (0.0% and 20.0%), whereas the DCR was similar across treatment lines. Reversible neutropenia was the most common grade 3/4 laboratory abnormality (19.4%). Conclusions: Trabectedin confers clinical benefit in patients with recurrent/metastatic uLMS, given after failure to an anthracycline-based regimen being comparable to those reported in clinical trials and with a manageable safety profile

Long-term outcomes of high-risk HR-positive and HER2-negative early breast cancer patients from GEICAM adjuvant studies and El Álamo IV registry

Purpose The monarchE trial showed that the addition of abemaciclib improves efficacy in patients with high-risk early breast cancer (EBC). We analyzed the long-term outcomes of a population similar to the monarchE trial to put into context the potential benefit of abemaciclib. Methods HR-positive/HER2-negative EBC patients eligible for the monarchE study were selected from 3 adjuvant clinical trials and a breast cancer registry. Patients with ≥ 4 positive axillary lymph nodes (N +) or 1–3 N + with tumor size ≥ 5 cm and/or histologic grade 3 and/or Ki67 ≥ 20%, who had undergone surgery with curative intent and had received anthracyclines ± taxanes and endocrine therapy in the neoadjuvant and /or adjuvant setting were included. We performed analysis of Invasive Disease-Free Survival (iDFS), Distant Disease-Free Survival (dDFS) and Overall Survival (OS) at 5 and 10 years, as well as yearly (up to 10) of Invasive Relapse Rate (IRR), Distant Relapse Rate (DRR) and Death Rate (DR). Results A total of 1,617 patients were analyzed from the GEICAM-9906 (312), GEICAM-2003–10 (210), and GEICAM-2006–10 (160) trials plus 935 from El Álamo IV. With a median follow-up of 10.1 years, the 5 and 10 years iDFS rates were 75.2% and 57.0%, respectively. The dDFS and OS rates at 5 years were 77.4% and 88.8% and the respective figures at 10 years were 59.7% and 70.9%. Conclusions This data points out the need for new therapies for those patients. A longer follow-up of the monarchE study to see the real final benefit with abemaciclib is warranted

Quality of life with palbociclib plus fulvestrant versus placebo plus fulvestrant in postmenopausal women with endocrine-sensitive hormone receptor-positive and HER2-negative advanced breast cancer : patient-reported outcomes from the FLIPPER trial

In the FLIPPER trial, palbociclib/fulvestrant significantly improved progression-free survival (PFS) compared with placebo/fulvestrant in postmenopausal women with HR+/HER2− advanced breast cancer (ABC). We assessed health-related quality of life (QoL) using patient-reported outcomes (PROs). In this phase II double-blinded study, PROs were assessed at baseline after every three cycles and at the end of the treatment using the European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-BR23. Time to deterioration (TTD) in global health status (GHS)/QoL was defined as a decrease of ⩾10 points. Changes from baseline (CFB) and TTD were analysed using linear mixed-effect and Cox regression models, respectively. Of the 189 randomised (1:1) patients, 178 (94%) completed ⩾1 post-baseline assessment; 50% received ⩾22 cycles of study treatment, with a questionnaire compliance >90%. Mean baseline scores were comparable between arms. GHS/QoL scores were maintained throughout the palbociclib/fulvestrant treatment. CFB showed significant differences for GHS/QoL, appetite loss, constipation and systemic therapy side effect scores favouring placebo/fulvestrant. TTD in GHS/QoL was delayed in placebo/fulvestrant versus palbociclib/fulvestrant [30.3 versus 11.1 months; adjusted hazard ratio (aHR): 1.57, 95% CI: 1.03-2.39, p = 0.036]; this difference was not significant in patients with progressive disease (aHR: 1.2, 95% CI: 0.6-2.2, p = 0.658). No statistically significant differences in TTD were found for the other QLQ-C30 and QLQ-BR23 scales. Although TTD in GHS/QoL was prolonged with placebo/fulvestrant, no differences were observed on other functional or symptom scales. This finding and the improvement in PFS support the combination of palbociclib/fulvestrant as a beneficial therapeutic option for HR+/HER2− ABC. Sponsor Study Code: GEICAM/2014-12 EudraCT Number: 2015-002437-21 ClinTrials.gov reference: NCT0269048

Palbociclib Rechallenge for Hormone Receptor–Positive/HER-Negative Advanced Breast Cancer: Findings from the Phase II BioPER Trial

Purpose: To assess the efficacy and exploratory biomarkers of continuing palbociclib plus endocrine therapy (ET) beyond pro-gression on prior palbociclib-based regimen in patients with hor-mone receptor-positive/HER2-negative (HR+/HER2-) advanced breast cancer (ABC).Patients and Methods: The multicenter, open-label, phase II BioPER trial included women who had experienced a progressive disease (PD) after having achieved clinical benefit on the immedi-ately prior palbociclib plus ET regimen. Palbociclib (125 mg, 100 mg, or 75 mg daily orally for 3 weeks and 1 week off as per prior palbociclib-based regimen) plus ET of physician's choice were administered in 4-week cycles until PD or unacceptable toxicity. Coprimary endpoints were clinical benefit rate (CBR) and percent-age of tumors with baseline loss of retinoblastoma (Rb) protein expression. Additional endpoints included safety and biomarker analysis.Results: Among 33 patients enrolled, CBR was 34.4% [95% confidence interval (CI), 18.6-53.2; P < 0.001] and 13.0% of tumors (95% CI, 5.2-27.5) showed loss of Rb protein expression, meeting both coprimary endpoints. Median progression-free survival was 2.6 months (95% CI, 1.8-6.7). No new safety signals were reported. A signature that included baseline mediators of therapeutic resistance to palbociclib and ET (low Rb score, high cyclin E1 score, ESR1 mutation) was independently associated with shorter median progression-free survival (HR, 22.0; 95% CI, 1.71-282.9; P = 0.018). Conclusions: Maintaining palbociclib after progression on prior palbociclib-based regimen seems to be a reasonable, investigational approach for selected patients. A composite biomarker signature predicts a subset of patients who may not derive a greater benefit from palbociclib rechallenge, warranting further validation in larger randomized controlled trials

Eligibility criteria for Menopausal Hormone Therapy (MHT): a position statement from a consortium of scientific societies for the use of MHT in women with medical conditions. MHT Eligibility Criteria Group

This project aims to develop eligibility criteria for menopausal hormone therapy (MHT). The tool should be similar to those already established for contraception A consortium of scientific societies coordinated by the Spanish Menopause Society met to formulate recommendations for the use of MHT by women with medical conditions based on the best available evidence. The project was developed in two phases. As a first step, we conducted 14 systematic reviews and 32 metanalyses on the safety of MHT (in nine areas: age, time of menopause onset, treatment duration, women with thrombotic risk, women with a personal history of cardiovascular disease, women with metabolic syndrome, women with gastrointestinal diseases, survivors of breast cancer or of other cancers, and women who smoke) and on the most relevant pharmacological interactions with MHT. These systematic reviews and metanalyses helped inform a structured process in which a panel of experts defined the eligibility criteria according to a specific framework, which facilitated the discussion and development process. To unify the proposal, the following eligibility criteria have been defined in accordance with the WHO international nomenclature for the different alternatives for MHT (category 1, no restriction on the use of MHT; category 2, the benefits outweigh the risks; category 3, the risks generally outweigh the benefits; category 4, MHT should not be used). Quality was classified as high, moderate, low or very low, based on several factors (including risk of bias, inaccuracy, inconsistency, lack of directionality and publication bias). When no direct evidence was identified, but plausibility, clinical experience or indirect evidence were available, "Expert opinion" was categorized. For the first time, a set of eligibility criteria, based on clinical evidence and developed according to the most rigorous methodological tools, has been defined. This will provide health professionals with a powerful decision-making tool that can be used to manage menopausal symptoms

A smart digital health platform to enable monitoring of quality of life and frailty in older patients with cancer: a mixed-methods, feasibility study protocol

Objectives: LifeChamps is an EU Horizon 2020 project that aims to create a digital platform to enable monitoring of health-related quality of life and frailty in patients with cancer over the age of 65. Our primary objective is to assess feasibility, usability, acceptability, fidelity, adherence, and safety parameters when implementing LifeChamps in routine cancer care. Secondary objectives involve evaluating preliminary signals of efficacy and cost-effectiveness indicators. Data Sources: This will be a mixed-methods exploratory project, involving four study sites in Greece, Spain, Sweden, and the United Kingdom. The quantitative component of LifeChamps (single-group, pre-post feasibility study) will integrate digital technologies, home-based motion sensors, self-administered questionnaires, and the electronic health record to (1) enable multimodal, real-world data collection, (2) provide patients with a coaching mobile app interface, and (3) equip healthcare professionals with an interactive, patient-monitoring dashboard. The qualitative component will determine end-user usability and acceptability via end-of-study surveys and interviews. Conclusion: The first patient was enrolled in the study in January 2023. Recruitment will be ongoing until the project finishes before the end of 2023. Implications for Nursing Practice: LifeChamps provides a comprehensive digital health platform to enable continuous monitoring of frailty indicators and health-related quality of life determinants in geriatric cancer care. Real-world data collection will generate “big data” sets to enable development of predictive algorithms to enable patient risk classification, identification of patients in need for a comprehensive geriatric assessment, and subsequently personalized care