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BACKGROUND: Cancer patients may experience a decrease in cognitive functioning before, during and after cancer treatment. So far, the Quality of Life Group of the European Organisation for Research and Treatment of Cancer (EORTC QLG) developed an item bank to assess self-reported memory and attention within a single, cognitive functioning scale (CF) using computerized adaptive testing (EORTC CAT Core CF item bank). However, the distinction between different cognitive functions might be important to assess the patients' functional status appropriately and to determine treatment impact. To allow for such assessment, the aim of this study was to develop and psychometrically evaluate separate item banks for memory and attention based on the EORTC CAT Core CF item bank. METHODS: In a multistep process including an expert-based content analysis, we assigned 44 items from the EORTC CAT Core CF item bank to the memory or attention domain. Then, we conducted psychometric analyses based on a sample used within the development of the EORTC CAT Core CF item bank. The sample consisted of 1030 cancer patients from Denmark, France, Poland, and the United Kingdom. We evaluated measurement properties of the newly developed item banks using confirmatory factor analysis (CFA) and item response theory model calibration. RESULTS: Item assignment resulted in 31 memory and 13 attention items. Conducted CFAs suggested good fit to a 1-factor model for each domain and no violations of monotonicity or indications of differential item functioning. Evaluation of CATs for both memory and attention confirmed well-functioning item banks with increased power/reduced sample size requirements (for CATs ≥ 4 items and up to 40% reduction in sample size requirements in comparison to non-CAT format). CONCLUSION: Two well-functioning and psychometrically robust item banks for memory and attention were formed from the existing EORTC CAT Core CF item bank. These findings could support further research on self-reported cognitive functioning in cancer patients in clinical trials as well as for real-word-evidence. A more precise assessment of attention and memory deficits in cancer patients will strengthen the evidence on the effects of cancer treatment for different cancer entities, and therefore contribute to shared and informed clinical decision-making.
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Neoplasias , Calidad de Vida , Humanos , Calidad de Vida/psicología , Psicometría/métodos , Encuestas y Cuestionarios , Reino Unido , Francia , Neoplasias/terapia , Neoplasias/psicologíaRESUMEN
PURPOSE: The European Organisation for Research and Treatment of Cancer (EORTC) quality of life core questionnaire (QLQ-C30) is a validated and widely-used Patient-Reported Outcome Measure for measuring the health-related quality of life (HRQoL) of cancer patients. To facilitate interpretation of results obtained in studies using the EORTC QLQ-C30, we generated normative data for the Dutch general population, stratified by age and sex. METHODS: Dutch participants were selected from a larger cross-sectional online panel research study collecting EORTC QLQ-C30 general population normative data across 15 countries. EORTC QLQ-C30 raw scores based on a 4-point response scale were transformed to linear scores ranging from 0 to 100. Transformed scores were weighted based on the United Nations population distribution statistics and presented by age and sex/age. Differences in scale scores of ≥ 10 points in HRQoL were applied to indicate clinical relevance. RESULTS: One thousand respondents completed the online survey. Stratified by age, clinically meaningful differences were observed, with worse physical functioning scores and better emotional functioning scores with increased age. Symptom scores remained stable across age groups, except for small age differences observed for fatigue, nausea/vomiting, diarrhoea, and financial difficulties. Stratified by sex/age, men generally scored better for both functioning and symptoms. However, these differences were not clinically meaningful. CONCLUSIONS: These updated normative EORTC QLQ-C30 for the Dutch general population can be used to better interpret HRQoL data obtained from Dutch cancer patients. Being part of a larger international study, these data can further be used for inter-country comparisons in multi-national studies.
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Neoplasias , Calidad de Vida , Masculino , Humanos , Calidad de Vida/psicología , Estudios Transversales , Neoplasias/terapia , Encuestas y Cuestionarios , EtnicidadRESUMEN
PURPOSE: Investigating the use of the EORTC bladder cancer (BC) modules by evaluating: (a) study contexts/designs; (b) languages/countries in which the modules were administered; (c) their acceptance by patients/investigators; and (d) their psychometric properties. METHODS: A systematic review was performed with studies from 1998 until 20/10/2021 in five databases. Articles/conference abstracts using the EORTC-QLQBLM30 (muscle invasive BC) and the EORTC-QLQNMIBC24 (previously referred to as QLQ-BLS24; non-muscle invasive BC) were included. Two authors independently screened titles/abstracts/full-texts and performed data extraction. RESULTS: A total of 76 eligible studies were identified. Most studies included the BLM30 (n = 53), were in a urological surgery context (n = 41) and were cross-sectional (n = 35) or prospective (n = 30) in design. The BC modules were administered in 14 languages across 19 countries. Missing data were low-moderate for all non-sex related questions (< 1% to 15%). Sex-related questions had higher rates of missing data (ranging from 6.9% to 84%). Most investigators did not use all scales of the questionnaires. One validation study for the original BLS24 led to the development of the NMIBC24, which adopted a new scale structure for which good structural validity was confirmed (n = 3). Good reliability and validity was shown for the NMIBC24 module, except for malaise and bloating/flatulence scales. Psychometric evidence for BLM30 is lacking. CONCLUSION: These results provide insight into how the EORTC BC quality of life modules could be further improved. Current work is ongoing to update the modules and to determine if the two modules can be combined into a single questionnaire that works well in both the NMIBC and MIBC settings.
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Calidad de Vida , Neoplasias de la Vejiga Urinaria , Humanos , Calidad de Vida/psicología , Reproducibilidad de los Resultados , Estudios Prospectivos , Encuestas y Cuestionarios , PsicometríaRESUMEN
OBJECTIVE: Risk-reducing salpingo-oophorectomy (RRSO) is advised before 40-45 years of age for BRCA1/2 mutation carriers. This study describes the effect of RRSO on lipid determinants, hemoglobin A1c (HbA1c) and C-reactive protein (CRP). METHODS: A total of 142 women with increased risk of ovarian cancer were included, 92 premenopausal and 50 postmenopausal. Serum levels of low-density lipoprotein (LDL)-cholesterol, high-density lipoprotein (HDL)-cholesterol and total cholesterol, triglycerides, HbA1c and CRP were determined at three points in time: before (T0) and 6 weeks (T1) and 7 months (T2) following RRSO. The Hot Flush Rating Scale was administered at the same time points. RESULTS: In premenopausal women, levels of HDL-cholesterol, the cholesterol ratio and HBA1c increased significantly over time, although still staying within the reference range. In this group, hot flushes increased over time (p < 0.001). In postmenopausal women, no significant changes were observed following RRSO. At T2, serum LDL-cholesterol, triglycerides, HbA1c and CRP were significantly lower in premenopausal women compared to postmenopausal women, whereas HDL was increased. CONCLUSIONS: Seven months after RRSO, the lipid profile in premenopausal women had changed, although still staying within the reference range. For postmenopausal women, we did not observe any significant changes. Our results do not suggest a worsening of cardiovascular risk within 7 months of RRSO.
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Neoplasias de la Mama , Neoplasias Ováricas , Femenino , Humanos , Salpingooforectomía/efectos adversos , Hemoglobina Glucada , Proteína BRCA1/genética , Proteína C-Reactiva , Proteína BRCA2/genética , Colesterol , Triglicéridos , Lípidos , Neoplasias Ováricas/genética , Ovariectomía , Mutación , Neoplasias de la Mama/etiologíaRESUMEN
BACKGROUND: Quality of Life (QoL) of bladder cancer patients has been largely neglected. This is partly due to the lack of well-validated QoL questionnaires. The aim of this study is to examine the structural validity, reliability (i.e., internal consistency and test-retest reliability), construct validity (i.e., divergent validity and known group validity) and responsiveness of the Dutch version of the European Organisation for Research and Treatment of Cancer QoL questionnaire for muscle invasive bladder cancer (EORTC-QLQ-BLM30). METHODS: Patients with newly diagnosed muscle invasive bladder cancer (MIBC) participating in the population-based 'Blaaskankerzorg In Beeld' (BlaZIB) study who completed the EORTC-QLQ-BLM30 at baseline were included. BlaZIB is a Dutch nationwide population-based prospective cohort study collecting clinical data and QoL data of bladder cancer patients. QoL is assessed with a self-administered questionnaire at four points in time: 6 weeks (baseline), 6 months, 12 months and 24 months after diagnosis. Confirmatory factor analysis and multitrait scaling analysis were used to investigate and adapt the scale structure. Reliability, construct validity and responsiveness of the revised scales were evaluated. RESULTS: Of the 1542 patients invited to participate, 650 patients (42.2%) completed the QLQ-BLM30 at baseline. The questionnaire's scale structure was revised into seven scales and eight single items. Internal consistency and test-reliability were adequate for most scales (Cronbach's α ≥0.70 and intraclass correlation coefficient ≥ 0.70, respectively), with the exception of the revised urostomy problem scale and abdominal bloating and flatulence scale. The questionnaire exhibited little overlap with the EORTC-QLQ-C30: all correlations were < 0.40, except for the correlation between emotional function (QLQ-C30) and future worries (QLQ-BLM30). The questionnaire was able to distinguish between patient subgroups formed on the basis of physical function, but not - as hypothesized- based on stage. Changes in health due to treatment were captured by the questionnaire, indicating that the questionnaire is responsive to change. CONCLUSIONS: This study shows that the adapted scale structure of the EORTC-QLQ-BLM30 generally exhibits good measurement properties in Dutch patients, but needs to be validated in other languages and settings. TRIAL REGISTRATION: BlaZIB, NL8106, www.trialregister.nl.
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Calidad de Vida , Neoplasias de la Vejiga Urinaria , Humanos , Reproducibilidad de los Resultados , Estudios Prospectivos , Encuestas y Cuestionarios , Psicometría , MúsculosRESUMEN
PURPOSE: To evaluate the feasibility and outcomes of a tailored, goal-directed, and exercise-based physical therapy program for patients with metastatic breast cancer (MBC). METHODS: This was an observational, uncontrolled feasibility study. The physical therapy intervention was highly tailored to the individual patient's goals, abilities, and preferences and could include functional, strength, aerobic, and relaxation exercises. Feasibility outcomes were participation rate (expected: 25%), safety, and adherence (percentage of attended sessions relative to scheduled sessions). Additional outcomes were goal attainment, self-reported physical functioning, fatigue, health-related quality of life, and patient and physical therapist satisfaction with the program. RESULTS: Fifty-five patients (estimated participation rate: 34%) were enrolled. Three patients did not start the intervention due to early disease progression. An additional 22 patients discontinued the program prematurely, mainly due to disease progression. Median intervention adherence was 90% and no major intervention-related adverse events occurred. A goal attainment score was available for 42 patients (of whom 29 had completed the program and 13 had prematurely dropped out). Twenty-two (52%) of these patients achieved their main goal fully or largely and an additional 15 patients (36%) partially. Eighty-five percent would "definitely recommend" the program to other patients with MBC. We observed a modest improvement in patient satisfaction with physical activities (Cohen's dz 0.33). CONCLUSION: The tailored intervention program was feasible in terms of uptake, safety, and outcomes and was highly valued by patients and physical therapists. However, disease progression interfered with the program, leading to substantial dropout. TRIAL REGISTRATION: NTR register: NTR6475.
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Neoplasias de la Mama/terapia , Terapia por Ejercicio/métodos , Calidad de Vida/psicología , Ejercicio Físico , Estudios de Factibilidad , Femenino , Objetivos , Humanos , Persona de Mediana Edad , Metástasis de la NeoplasiaRESUMEN
BACKGROUND: The European Organization for Research and Treatment of Cancer (EORTC) QLQ-BR23 was one of the first disease-specific questionnaires developed in 1996 to assess quality of life (QoL) in patients with breast cancer (BC). However, since 1996 major changes in BC treatment have occurred, requiring an update of the EORTC BC module. This study presents the results of the phase I-III update of the QLQ-BR23 questionnaire. PATIENTS AND METHODS: The update of the EORTC QLQ-BR23 module followed standard EORTC guidelines. A systematic literature review revealed 83 potential relevant QoL issues during phases I and II. After shortening the issues list and following interviews with patients and health care providers, 15 relevant issues were transformed into 27 items. The preliminary module was pretested in an international, multicentre phase III study to identify and solve potential problems with wording comprehensibility and acceptability of the items. Descriptive statistics are provided. Analyses were qualitative and quantitative. We provide a psychometric structure of the items. RESULTS: The phase I and II results indicated the need to supplement the original QLQ-BR23 with additional items related to newer therapeutic options. The phase III study recruited a total of 250 patients (from 12 countries). The final updated phase III module contains a total of 45 items: 23 items from the QLQ-BR23 and 22 new items. The new items contain two multi-item scales: a target symptom scale and a satisfaction scale. The target symptom scale can be divided into three subscales: endocrine therapy, endocrine sexual and skin/mucosa scale. CONCLUSION: Our work has led to the development of a new EORTC QLQ-BR45 module that provides a more accurate and comprehensive assessment of the impact of new and scalable treatments on patients' QoL. The final version of the EORTC QLQ-BR45 is currently available for use in clinical practice. The final phase IV study is underway to confirm psychometric properties of the module.
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Neoplasias de la Mama , Calidad de Vida , Neoplasias de la Mama/tratamiento farmacológico , Ensayos Clínicos como Asunto , Humanos , Psicometría , Reproducibilidad de los Resultados , Encuestas y CuestionariosRESUMEN
BACKGROUND: The incidence of colorectal cancer (CRC) is highest among the elderly. An important treatment modality is surgery. After surgery, due to poor functional recovery, some elderly have an increased risk for complications and prolonged length of hospital stay (LOS). Preoperative elevated levels of fatigue and impaired functioning in instrumental activities of daily living (iADL) might be associated with these outcomes, and may, therefore, be helpful to recognize patients with elevated risk for complications or prolonged LOS, who should undergo more thorough functional assessment. AIMS: This exploratory study aims to assess whether physical fatigue, reduced activity and/or iADL, assessed preoperatively, are associated with postoperative complications and prolonged LOS, in elderly patients undergoing surgery for CRC. METHODS: We performed an exploratory prospective study in older (≥ 65 years) patients (n = 57) who were scheduled to undergo elective surgery for colorectal cancer. Fatigue and iADL functioning were assessed with questionnaires. Multivariable regression analyses were used to examine the relationship of fatigue and iADL with complications and LOS. RESULTS: IADL was not associated with complications or LOS. Fatigue was not associated with complications. Patients with higher fatigue had increased LOS in the univariable analyses but not in the multivariable analyses after adjustment for nutritional status and neoadjuvant treatment. DISCUSSION: We found that fatigue was associated with increased LOS in the univariable analysis. The results from the multivariable analysis and path analysis indicate, however, that this is likely not a causal relationship; the observed relationship between physical fatigue and LOS appears to be confounded by nutritional status and by having received neoadjuvant treatment. CONCLUSIONS: Although fatigue is a predictor for increased LOS, assessment of fatigue and iADL has no additional value for identifying elderly at risk for poor functional outcome after CRC surgery.
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Actividades Cotidianas , Neoplasias Colorrectales/cirugía , Procedimientos Quirúrgicos del Sistema Digestivo/efectos adversos , Fatiga/etiología , Complicaciones Posoperatorias , Anciano , Anciano de 80 o más Años , Procedimientos Quirúrgicos Electivos/efectos adversos , Femenino , Humanos , Tiempo de Internación , Masculino , Estado Nutricional , Estudios Prospectivos , Recuperación de la FunciónRESUMEN
BACKGROUND: Physical activity has beneficial effects on the health of cancer survivors. We aimed to investigate accelerometer-assessed physical activity and sedentary time in cancer survivors, and describe activity profiles. Additionally, we identify demographic and clinical correlates of physical activity, sedentary time and activity profiles. METHODS: Accelerometer, questionnaire and clinical data from eight studies conducted in four countries (n = 1447) were pooled. We calculated sedentary time and time spent in physical activity at various intensities using Freedson cut-points. We used latent profile analysis to identify activity profiles, and multilevel linear regression analyses to identify demographic and clinical variables associated with accelerometer-assessed moderate to vigorous physical activity (MVPA), sedentary time, the highly active and highly sedentary profile, adjusting for confounders identified using a directed acyclic graph. RESULTS: Participants spent on average 26 min (3%) in MVPA and 568 min (66%) sedentary per day. We identified six activity profiles. Older participants, smokers and participants with obesity had significantly lower MVPA and higher sedentary time. Furthermore, men had significantly higher MVPA and sedentary time than women and participants who reported less fatigue had higher MVPA time. The highly active profile included survivors with high education level and normal body mass index. Haematological cancer survivors were less likely to have a highly active profile compared to breast cancer survivors. The highly sedentary profile included older participants, males, participants who were not married, obese, smokers, and those < 12 months after diagnosis. CONCLUSIONS: Cancer survivors engage in few minutes of MVPA and spend a large proportion of their day sedentary. Correlates of MVPA, sedentary time and activity profiles can be used to identify cancer survivors at risk for a sedentary and inactive lifestyle.
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Supervivientes de Cáncer/estadística & datos numéricos , Ejercicio Físico , Conducta Sedentaria , Acelerometría , Estudios de Cohortes , Femenino , Monitores de Ejercicio , Humanos , MasculinoRESUMEN
PURPOSE: In this study we aimed (1) to identify the most prevalent physical symptoms and functional limitations that limit physical activity of patients with palliative treatment for metastatic breast cancer (MBC) and (2) to identify their preferences for exercise-based physical therapy programs, as a first step towards the development of physical therapist (PT)-guided exercise programs for patients with MBC. METHODS: We performed a mixed-method study that comprised a cross-sectional survey and two focus group sessions among patients with MBC. Survey results were analyzed using descriptive statistics. The focus groups were audio-taped, transcribed verbatim, and analyzed independently by two researchers, using directed content analysis. RESULTS: A total of 114 women (response rate 61%) completed the survey (mean age 63.5, SD 10.2). Eighty-six percent of the women reported at least some level of physical problems limiting their ability to be physically active, of whom 46% reported substantial problems. The most prevalent problems were fatigue, painful joints, painful muscles, and shortness of breath. Uptake of exercise appeared to be limited. Exercise preferences varied strongly. Fifty-three percent indicated a preference for some form of PT-supervision, and 34% for a prolonged period of time (> 8 weeks). Focus group results clarified that patients' preferences for supervision, by PTs with special qualifications in oncology, were related to feelings of insecurity about their ability to self-manage physical functioning. CONCLUSIONS: Patients with MBC experience a broad range of physical health problems that limit their ability to be physically active. While preferences vary strongly, patients with MBC would value the availability of high quality, PT-guided, tailored exercise programs.
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Neoplasias de la Mama/fisiopatología , Neoplasias de la Mama/terapia , Terapia por Ejercicio/métodos , Adulto , Anciano , Anciano de 80 o más Años , Estudios Transversales , Fatiga/etiología , Fatiga/terapia , Femenino , Humanos , Persona de Mediana Edad , Prioridad del Paciente , Fisioterapeutas , Calidad de Vida , Encuestas y CuestionariosRESUMEN
PURPOSE: Central cancer registries collect data and provide population-level statistics that can be tracked over time; yet registries may not capture the full range of clinically relevant outcomes. Patient-generated health data (PGHD) include health/treatment history, biometrics, and patient-reported outcomes (PROs). Collection of PGHD would broaden registry outcomes to better inform research, policy, and care. However, this is dependent on the willingness of patients to share such data. This study examines cancer survivors' perspectives about sharing PGHD with central cancer registries. METHODS: Three U.S. central registries sampled colorectal, non-Hodgkin lymphoma, and metastatic breast cancer survivors 1-4 years after diagnosis, recruiting them via mail to participate in one of seven focus groups (n = 52). Group discussions were recorded, transcribed, and thematically analyzed. RESULTS: Most survivor-participants were unaware of the existence of registries. After having registries explained, all participants expressed their willingness to share PGHD with them if treated confidentially. Participants were willing to provide information on a variety of topics (e.g., medical history, medications, symptoms, financial difficulties, quality of life, biometrics, nutrition, exercise, and mental health), with a focus on long-term effects of cancer and its treatment. Participants' preferred mode for providing data varied. Participants were also interested in receiving information from registries. CONCLUSIONS: Our results suggest that registry-based collection of PGHD is acceptable to most cancer survivors and could facilitate registry-based efforts to collect PGHD/PROs. Central cancer registry-based collection of PGHD/PROs, especially on long-term effects, could enhance registry support of cancer control efforts including research and population health management.
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Supervivientes de Cáncer/psicología , Recolección de Datos/métodos , Manejo de Datos/métodos , Atención a la Salud/métodos , Medición de Resultados Informados por el Paciente , Calidad de Vida/psicología , Sistema de Registros/normas , Femenino , Grupos Focales , Humanos , Masculino , Persona de Mediana EdadRESUMEN
BACKGROUND: Higher levels of physical activity (PA) after treatment are associated with beneficial effects on physical and psychosocial functioning of cancer survivors. However, survivors often do not meet the recommended levels of PA. In order to promote PA, we developed a closed internet-based program. The aim of the study is to evaluate the (cost-)effectiveness of an internet-based PA-promotion program, alone or combined with physiotherapy counselling, compared to usual care, on PA-levels of breast or prostate cancer survivors. In this multicenter randomised controlled trial (RCT), breast or prostate cancer survivors who completed their primary treatment 3-12 months earlier, will be randomised to either 6-months access to a fully-automated internet-based intervention alone, an internet-based intervention plus remote support by a physiotherapist, or a control group. The intervention is based on the Transtheoretical Model and includes personalized feedback, information, video's and assignments. Additionally, in a second arm, physiotherapy counselling is provided through monthly scheduled and on-demand telephone calls. The control group will receive usual care and a leaflet with PA guidelines. METHODS: At baseline, 6 and 12 months, the primary outcome (PA) will be measured during 7 consecutive days by accelerometers. Secondary outcomes are self-reported PA, fatigue, mood, health-related quality of life, and costs. The group differences for primary and secondary outcomes will be analyzed using linear mixed models. DISCUSSION: If proven to be (cost)effective, this internet-based intervention, either alone or in combination with telephone support, will be a welcome addition to previous RCT's. TRIAL REGISTRATION: Netherlands trial register (NTR6911), Date of trial registration: December 21, 2017.
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Neoplasias de la Mama/terapia , Ejercicio Físico/fisiología , Internet , Neoplasias de la Próstata/terapia , Anciano , Neoplasias de la Mama/economía , Neoplasias de la Mama/epidemiología , Neoplasias de la Mama/fisiopatología , Supervivientes de Cáncer , Análisis Costo-Beneficio , Femenino , Humanos , Masculino , Persona de Mediana Edad , Países Bajos , Especialidad de Fisioterapia , Neoplasias de la Próstata/economía , Neoplasias de la Próstata/epidemiología , Neoplasias de la Próstata/fisiopatologíaRESUMEN
OBJECTIVE: This individual patient data (IPD) meta-analysis aimed to evaluate the effects of psychosocial interventions (PSI) on quality of life (QoL), emotional function (EF), and social function (SF) in patients with cancer, and to study moderator effects of demographic, clinical, personal, and intervention-related characteristics. METHODS: Relevant studies were identified via literature searches in 4 databases. We pooled IPD from 22 (n = 4217) of 61 eligible randomized controlled trials. Linear mixed-effect model analyses were used to study intervention effects on the post-intervention values of QoL, EF, and SF (z-scores), adjusting for baseline values, age, and cancer type. We studied moderator effects by testing interactions with the intervention for demographic, clinical, personal, and intervention-related characteristics, and conducted subsequent stratified analyses for significant moderator variables. RESULTS: PSI significantly improved QoL (ß = 0.14,95%CI = 0.06;0.21), EF (ß = 0.13,95%CI = 0.05;0.20), and SF (ß = 0.10,95%CI = 0.03;0.18). Significant differences in effects of different types of PSI were found, with largest effects of psychotherapy. The effects of coping skills training were moderated by age, treatment type, and targeted interventions. Effects of psychotherapy on EF may be moderated by cancer type, but these analyses were based on 2 randomized controlled trials with small sample sizes of some cancer types. CONCLUSIONS: PSI significantly improved QoL, EF, and SF, with small overall effects. However, the effects differed by several demographic, clinical, personal, and intervention-related characteristics. Our study highlights the beneficial effects of coping skills training in patients treated with chemotherapy, the importance of targeted interventions, and the need of developing interventions tailored to the specific needs of elderly patients.
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Ajuste Emocional , Neoplasias/psicología , Neoplasias/rehabilitación , Rehabilitación Psiquiátrica/psicología , Psicoterapia , Calidad de Vida/psicología , Ajuste Social , Adulto , Anciano , Femenino , Humanos , Individualidad , Masculino , Persona de Mediana Edad , Rehabilitación Psiquiátrica/métodos , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
OBJECTIVES: The aim of this study was to investigate whether serum anti-Müllerian hormone (AMH) predicts symptom burden after risk-reducing salpingo-oophorectomy (RRSO) in order to individualize counseling. METHODS: Patient-reported menopausal symptoms, sexual functioning, and psychological distress (depression and anxiety) were assessed 1 day before (T0) and 6 weeks (T1) and 7 months (T2) after RRSO. AMH was assessed before RRSO. Multivariable regression analysis was used to investigate the association between AMH and short-term and long-term change in symptom burden following RRSO. RESULTS: Ninety-one premenopausal women at high risk of ovarian cancer were included. Presurgical AMH was not related significantly to change in symptoms post RRSO. As a secondary outcome we found that regular menses before RRSO was associated specifically with long-term increase in hot flushes (sr = 0.40, p = 0.001; total R2 = 0.171) and depression (sr = 0.29, p = 0.012; total R2 = 0.132). Earlier receipt of chemotherapy was associated with long-term improvement in sexual functioning (sr = 0.24, p = 0.041; total R2 = 0.348). CONCLUSION: In this cohort, AMH was not a significant predictor of change in symptoms following RRSO. Regular menses prior to RRSO and earlier receipt of chemotherapy were significantly, but relatively weakly, associated with changes in outcomes 6 weeks and/or 7 months after RRSO.
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Hormona Antimülleriana/sangre , Neoplasias de la Mama/complicaciones , Menopausia/sangre , Neoplasias Ováricas/prevención & control , Salpingooforectomía/efectos adversos , Adulto , Femenino , Humanos , Persona de Mediana Edad , Análisis Multivariante , Países Bajos , Neoplasias Ováricas/sangre , Estudios Prospectivos , Calidad de Vida , Análisis de Regresión , Conducta de Reducción del Riesgo , Encuestas y CuestionariosRESUMEN
Advances in cancer care delivery require revision and further development of questionnaires assessing patients' perceived quality of care. This study pre-tested the revised EORTC satisfaction with cancer care core questionnaire applicable in both the cancer inpatient and outpatient settings, and its new, outpatient-specific complementary module. The process of revision, development of the extended application, and pre-testing of these questionnaires was based on phases I to III of the "EORTC Quality of Life Group Module Development Guidelines." In phase III, patients in 11 countries in four European regions, South America and Asia completed provisional versions of the questionnaires. Fifty-seven relevant issues selected from literature reviews and input from experts were operationalized into provisional items, and subsequently translated into ten languages. Assessment of understanding, acceptability, redundancy and relevance by patients (n = 151) from oncology inpatient wards, and outpatient chemotherapy, radiotherapy and consultation settings, led to retention of, deletion of and merging of 40, 14 and 6 items respectively. Cronbach's alpha coefficients for hypothesized questionnaire scales were above 0.80. Our results provide preliminary support for the 33-item EORTC Satisfaction with cancer care core questionnaire and the 7-item complementary module specific for the outpatient care setting. A large scale phase IV cross-cultural psychometric study is now underway.
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Neoplasias/terapia , Satisfacción del Paciente , Anciano , Atención Ambulatoria , Europa (Continente) , Femenino , Humanos , Masculino , Persona de Mediana Edad , Sociedades Médicas , Encuestas y CuestionariosRESUMEN
PURPOSE: Cancer-related fatigue (CRF) is one of the most frequently reported symptoms in cancer survivors. To be able to optimally treat CRF, knowledge of symptoms that interact with CRF is helpful. During aging, changes occur in body composition with progressive deterioration in physiological functions and metabolic processes causing a decline of adaptive capacity. Therefore, symptoms caused by cancer and its treatment might coexist in different symptom clusters in older cancer survivors, compared to younger survivors. The purpose of this analysis was to identify and compare symptom clusters that include CRF between older and younger survivors of colorectal cancer (CRC). METHODS: Data were drawn from a cross-sectional study from the Netherlands Cancer Registry. In total, 1698 stage I and II CRC survivors diagnosed from 2000 to 2009 completed questionnaires on fatigue and psychological distress. Survivors were categorized in two groups based on age (≤65 versus >65 years) Symptom clusters were assessed using principal component analysis. A sensitivity analysis was performed on the results with categorical principal component analysis. RESULTS: In both age groups, three components including two symptom clusters were identified: an emotional symptom cluster containing anxiety, fatigue, and depression; a pain symptom cluster containing pain and insomnia; and a third component containing dyspnea only. CONCLUSIONS: Symptom clusters in survivors of CRC appear to be independent of age. In treating CRC survivors for fatigue, regardless of age, it is advisable to assess depression and anxiety and, if necessary, refer for further diagnosis and treatment.
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Neoplasias Colorrectales/complicaciones , Fatiga/etiología , Calidad de Vida/psicología , Sobrevivientes/psicología , Adulto , Anciano , Neoplasias Colorrectales/mortalidad , Neoplasias Colorrectales/psicología , Estudios Transversales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Encuestas y Cuestionarios , SíndromeRESUMEN
OBJECTIVE: For many years, intensive research has been dedicated to the development of sensitive biomarkers to detect various malignant diseases, including for the differentiation between a benign or malignant ovarian mass. One of these biomarkers is human epididymal protein 4 (HE4), which has been shown to have a higher specificity than, and comparable sensitivity to CA 125. HE4 is included in some predictive models. These new models have not yet been widely implemented in standard clinical care. The authors investigated the perceived need for new biomarkers and prediction models among Dutch gynecologists. MATERIALS AND METHODS: A web-based survey containing 38 questions was sent to all gynecologists (in training) registered by the Dutch Society of Obstetrics and Gynecology. RESULTS: 313 respondents completed the survey (23% response rate), of which 29% were specialized in or devoted at least part of their practice to oncology. Approximately two-thirds of the respondents indicated that there is a need for a new biomarker. Respondents indicated that they would use HE4 primarily as a diagnostic tool in the case of a pelvic mass (57%), followed by screening in case of risk factors (30%), detection of recurrent disease (23%), monitoring therapy response (22%), and as a prognostic factor (10%). Only 11% would not use HE4 at all. CONCLUSION: Evaluating the need for new technologies and diagnostics, including biomarkers, is important to avoid expensive research with min- imal clinical implications. In general, there is a perceived need for a new biomarker, if it can be used to improve the accuracy of diagnosis in patients with a pelvic mass.
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Biomarcadores de Tumor/análisis , Neoplasias Glandulares y Epiteliales/diagnóstico , Neoplasias Ováricas/diagnóstico , Proteínas/análisis , Carcinoma Epitelial de Ovario , Femenino , Humanos , Neoplasias Glandulares y Epiteliales/química , Neoplasias Ováricas/química , Proteína 2 de Dominio del Núcleo de Cuatro Disulfuros WAPRESUMEN
BACKGROUND: Little is known about employment outcomes after breast cancer (BC) beyond the first years after treatment. METHODS: Employment outcomes were compared with a general population comparison group (N=91 593) up to 10 years after BC for 26 120 patients, diagnosed before age 55 between 2000-2005, with income and social benefits data from Statistics Netherlands. Treatment effects were studied in 14 916 patients, with information on BC recurrences and new cancer events. RESULTS: BC survivors experienced higher risk of losing paid employment (Hazard Ratio (HR): 1.6, 95% Confidence Interval (95% CI) 1.4-1.8) or any work-related event up to 5-7 years (HR 1.5, 95% CI 1.3-1.6) and of receiving disability benefits up to 10 years after diagnosis (HR 2.0, 95% CI 1.6-2.5), with higher risks for younger patients. Axillary lymph node dissection increased risk of disability benefits (HR 1.5, 95% CI 1.4-1.7) or losing paid employment (HR 1.3, 95% CI 1.2-1.5) during the first 5 years of follow-up. Risk of disability benefits was increased among patients receiving mastectomy and radiotherapy (HR 1.2; 95% CI 1.1-1.3) and after chemotherapy (HR 1.7; 95% CI 1.5-1.9) during the first 5 years after diagnosis. CONCLUSIONS: BC treatment at least partly explains the increased risk of adverse employment outcomes up to 10 years after BC.
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Neoplasias de la Mama/terapia , Empleo , Bienestar Social , Femenino , Humanos , Modelos de Riesgos Proporcionales , Factores de TiempoRESUMEN
PURPOSE: To investigate patients' and health professionals' understanding of and preferences for different graphical presentation styles for individual-level EORTC QLQ-C30 scores. METHODS: We recruited cancer patients (any treatment and diagnosis) in four European countries and health professionals in the Netherlands. Using a questionnaire, we assessed objective and self-rated understanding of QLQ-C30 scores and preferences for five presentation styles (bar and line charts, with or without color coding, and a heat map). RESULTS: In total, 548 patients and 227 health professionals participated. Eighty-three percent of patients and 85 % of professionals self-rated the graphs as very or quite easy to understand; this did not differ between graphical presentation styles. The mean percentage of correct answers to questions objectively assessing understanding was 59 % in patients, 78 % in medical specialists, and 74 % in other health professionals. Objective understanding did not differ between graphical formats in patients. For non-colored charts, 49.8 % of patients did not have a preference. Colored bar charts (39 %) were preferred over heat maps (20 %) and colored line charts (12 %). Medical specialists preferred heat maps (46 %) followed by non-colored bar charts (19 %), whereas these charts were equally valued by other health professionals (both 32 %). CONCLUSION: The substantial discrepancy between participants' high self-rated and relatively low objective understanding of graphical presentation of PRO results highlights the need to provide sufficient guidance when presenting such results. It may be appropriate to adapt the presentation of PRO results to individual preferences. This could be facilitated when PROs are administered and presented to patients and health professionals electronically.
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Actitud del Personal de Salud , Comprensión , Gráficos por Computador , Indicadores de Salud , Evaluación del Resultado de la Atención al Paciente , Prioridad del Paciente/estadística & datos numéricos , Calidad de Vida , Adulto , Anciano , Anciano de 80 o más Años , Estudios Transversales , Europa (Continente) , Femenino , Humanos , Masculino , Persona de Mediana Edad , Neoplasias , Países BajosRESUMEN
PURPOSE: To assess the feasibility of using a discrete choice experiment (DCE) to value health states within the QLU-C10D, a utility instrument derived from the QLQ-C30, and to assess clarity, difficulty, and respondent preference between two presentation formats. METHODS: We ran a DCE valuation task in an online panel (N = 430). Respondents answered 16 choice pairs; in half of these, differences between dimensions were highlighted, and in the remainder, common dimensions were described in text and differing attributes were tabulated. To simplify the cognitive task, only four of the QLU-C10D's ten dimensions differed per choice set. We assessed difficulty and clarity of the valuation task with Likert-type scales, and respondents were asked which format they preferred. We analysed the DCE data by format with a conditional logit model and used Chi-squared tests to compare other responses by format. Semi-structured telephone interviews (N = 8) explored respondents' cognitive approaches to the valuation task. RESULTS: Four hundred and forty-nine individuals were recruited, 430 completed at least one choice set, and 422/449 (94 %) completed all 16 choice sets. Interviews revealed that respondents found ten domains difficult but manageable, many adopting simplifying heuristics. Results for clarity and difficulty were identical between formats, but the "highlight" format was preferred by 68 % of respondents. Conditional logit parameter estimates were monotonic within domains, suggesting respondents were able to complete the DCE sensibly, yielding valid results. CONCLUSION: A DCE valuation task in which only four of the QLU-C10D's ten dimensions differed in any choice set is feasible for deriving utility weights for the QLU-C10D.