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1.
Support Care Cancer ; 31(8): 459, 2023 Jul 11.
Artigo em Inglês | MEDLINE | ID: mdl-37432501

RESUMO

PURPOSE: To determine the experiences, information, support needs and quality of life of women in the UK living with metastatic breast cancer (MBC) to provide content for educational materials. METHODS: An online survey, hosted for 3 months on a UK MBC charity website, comprised sections covering issues such as communication about MBC treatment and management, helpful and less helpful things that healthcare professionals, family and friends did or said and completion of the Patient Roles and Responsibilities Scale (PRRS). RESULTS: A total of 143 patients participated; 48/143(33%) presented de novo; 54/143(38%) had been living with MBC > 2 years. PRRS analysis revealed that MBC imposed a serious impact upon most respondents' own caring abilities and social lives. A majority 98/139 (71%) wished they had known more about MBC before their diagnosis; 63/134(47%) indicated that they still did not fully understand their illness; merely 78/139(56%) had access to a specialist nurse and only 69/135(51%) had been offered any additional support. Respondents reported little consideration given to their lifestyle/culture during consultations and inconsistent information, support services, continuity of care or access to clinical trials. They commented upon things health care professionals/friends and family did or said that were useful and cited other behaviours that were especially unhelpful. CONCLUSIONS: MBC exerted a deleterious impact upon patients' activities of daily living which were exacerbated in part by significant gaps in support, communication and information. IMPLICATIONS FOR CANCER SURVIVORS: LIMBER results are informing the content of educational materials currently being developed for patients' formal and informal carers.


Assuntos
Neoplasias da Mama , Síndrome Respiratória e Reprodutiva Suína , Suínos , Animais , Humanos , Feminino , Qualidade de Vida , Atividades Cotidianas , Neoplasias da Mama/terapia , Reino Unido
2.
Breast Cancer Res Treat ; 192(2): 265-271, 2022 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-34982321

RESUMO

PURPOSE: To compare participants' knowledge about gene expression profiling (GEP) tests and recurrence risks after reading an information leaflet with that following viewing of an information film. METHODS: Using a randomised cross-over design, at time-point one (T1), women aged 45-75 years without breast cancer either read leaflets or watched information films about Oncotype DX or Prosigna tests. Participants answered nine questions assessing knowledge (maximum score 18). Next-day information in the opposite modality was provided and knowledge re-assessed. Additional questions probed which format was easiest to understand, participants' preferences for film or leaflet and their reasons for these. RESULTS: 120 women participated (60 received OncotypeDX films and leaflets; 60 received the Prosigna versions). T1 mean knowledge scores were higher following film viewing (13.37) compared with that after reading leaflets (9.25) (mean difference 4.1; p < 0.0001; 95% CI 3.2, 5.0). When participants read leaflets first and subsequently viewed films, all increased their scores (mean + 6.08, from T1 of 9.25, p < 0.0001; 95% CI 5.44, 6.72). When films were viewed first, followed by leaflets, (36/60, 60%), participants' scores declined (mean-1.55 from T1 of 13.37, p < 0.001; 95% CI -2.32, -0.78). A majority of participants expressed preferences for the films (88/120, 73.3%) irrespective as to whether they described OncotypeDX or Prosigna. Reasons included the clarity, ease of understanding, visual material and reassuring voice-over. CONCLUSION: Discussions between oncologists and patients about recurrence risk results can be challenging. Information leaflets may aid understanding but often employ complex language. Information films significantly improved knowledge and were preferred by participants.


Assuntos
Neoplasias da Mama , Idoso , Neoplasias da Mama/diagnóstico , Neoplasias da Mama/genética , Estudos Cross-Over , Feminino , Perfilação da Expressão Gênica , Humanos , Pessoa de Meia-Idade
3.
Support Care Cancer ; 28(10): 4589-4612, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32533435

RESUMO

BACKGROUND: Digital health provides solutions that capture patient-reported outcomes (PROs) and allows symptom monitoring and patient management. Digital therapeutics is the provision to patients of evidence-based therapeutic interventions through software applications aimed at prevention, monitoring, management, and treatment of symptoms and diseases or for treatment optimization. The digital health solutions collecting PROs address many unmet needs, including access to care and reassurance, increase in adherence and treatment efficacy, and decrease in hospitalizations. With current developments in oncology including increased availability of oral drugs and reduced availability of healthcare professionals, these solutions offer an innovative approach to optimize healthcare resource utilization. DESIGN: This scoping review clarifies the role and impact of the digital health solutions in oncology supportive care, with a view of the current segmentation according to their technical features (connection to sensors, PRO collection, remote monitoring, self-management in real time…), and identifies evidence from clinical studies published about their benefits and limitations and drivers and barriers to adoption. A qualitative summary is presented. RESULTS: Sixty-six studies were identified and included in the qualitative synthesis. Studies supported the use of 38 digital health solutions collecting ePROs and allowing remote monitoring, with benefits to patients regarding symptom reporting and management, reduction in symptom distress, decrease in unplanned hospitalizations and related costs and improved quality of life and survival. Among those 38 solutions 21 provided patient self-management with impactful symptom support, improvement of QoL, usefulness and reassurance. Principal challenges are in developing and implementing digital solutions to suit most patients, while ensuring patient compliance and adaptability for use in different healthcare systems and living environments. CONCLUSIONS: There is growing evidence that digital health collecting ePROs provide benefits to patients related to clinical and health economic endpoints. These digital solutions can be integrated into routine supportive care in oncology practice to provide improved patient-centered care.


Assuntos
Oncologia/métodos , Qualidade de Vida/psicologia , Telemedicina/métodos , Humanos
4.
Ann Oncol ; 30(4): 567-574, 2019 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-30689703

RESUMO

BACKGROUND: We report longitudinal health-related quality-of-life (HRQoL) data from the international, randomized, double-blind, placebo-controlled phase III ExteNET study, which demonstrated an invasive disease-free survival benefit of extended adjuvant therapy with neratinib over placebo in human epidermal growth factor receptor-2-positive early-stage breast cancer. PATIENTS AND METHODS: Women (N = 2840) with early-stage HER2-positive breast cancer who had completed trastuzumab-based adjuvant therapy were randomly assigned to neratinib 240 mg/day or placebo for 12 months. HRQoL was an exploratory end point. Patients completed the Functional Assessment of Cancer Therapy-Breast (FACT-B) and EuroQol 5-Dimensions (EQ-5D) questionnaires at baseline and months 1, 3, 6, 9, and 12. Changes from baseline were compared using analysis of covariance with no imputation for missing values. Sensitivity analyses used alternative methods. Changes in HRQoL scores were regarded as clinically meaningful if they exceeded previously reported important differences (IDs). RESULTS: Of the 2840 patients (intention-to-treat population), 2407 patients were evaluable for FACT-B (neratinib, N = 1171; placebo, N = 1236) and 2427 patients for EQ-5D (neratinib, N = 1186; placebo, N = 1241). Questionnaire completion rates exceeded 85%. Neratinib was associated with a decrease in global HRQoL scores at month 1 compared with placebo (adjusted mean differences: FACT-B total, -2.9 points; EQ-5D index, -0.02), after which between-group differences diminished at later time-points. Except for the FACT-B physical well-being (PWB) subscale at month 1; all between-group differences were less than reported IDs. The FACT-B breast cancer-specific subscale showed small improvements with neratinib at months 3-9, but all were less than IDs. Sensitivity analyses exploring missing data did not change the results. CONCLUSIONS: Extended adjuvant neratinib was associated with a transient, reversible decrease in HRQoL during the first month of treatment, possibly linked to treatment-related diarrhea. With the exception of the PWB subscale at month 1, all neratinib-related HRQoL changes did not reach clinically meaningful thresholds. ClinicalTrials.gov: NCT00878709.


Assuntos
Antineoplásicos/efeitos adversos , Neoplasias da Mama/terapia , Qualidade de Vida , Quinolinas/efeitos adversos , Receptor ErbB-2/antagonistas & inibidores , Adulto , Idoso , Idoso de 80 Anos ou mais , Antineoplásicos/administração & dosagem , Neoplasias da Mama/mortalidade , Neoplasias da Mama/patologia , Quimioterapia Adjuvante/efeitos adversos , Quimioterapia Adjuvante/métodos , Intervalo Livre de Doença , Método Duplo-Cego , Feminino , Humanos , Estudos Longitudinais , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Placebos/administração & dosagem , Placebos/efeitos adversos , Quinolinas/administração & dosagem , Receptor ErbB-2/metabolismo , Trastuzumab/administração & dosagem , Adulto Jovem
5.
Breast Cancer Res Treat ; 177(3): 641-649, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31201584

RESUMO

PURPOSE: Gene expression profiling (GEP) test scores calculate risks of recurrence and likely benefit of adjuvant chemotherapy in ER-positive, HER2-negative, early-stage breast cancer. As health literacy and numeracy skills in the general population are poor, healthcare professionals (HCPs) require a wide repertoire of communication skills to explain clearly risk of recurrence scores (RSs) and uncertainty. We developed and evaluated an educational program for HCPs discussing GEP test results and adjuvant treatment. METHODS: Eight-hour workshops contained elements aimed at improving knowledge, communication skills and self-awareness; these included the science underpinning GEP tests, an interactive risk psychology lecture, exercises and facilitated group discussions regarding seven filmed scenarios involving discussions about high, intermediate and low RSs. Attendees were recorded explaining RSs with patient simulators pre and post workshop. Researchers, blinded to time point, analysed recordings using a study-specific scoring system. Primary objective outcomes were improvements post workshop in HCPs' competence and confidence when communicating 17 pre-specified key information areas. We estimated odds ratios (OR) using conditional logistic regression to compare pre- and post-workshop scores. RESULTS: 65 HCPs attended. Objective analyses revealed significant positive shifts post workshop which included explaining GEP tests (OR 2.98; 95% CI 1.38-6.42; P = .001), recurrence RSs (OR 3.99; 95% CI 1.72-9.25; P < .001), benefits of chemotherapy (OR 3.99; 95% CI 1.82-8.75; P < .001; and harms OR 2.31; 95% CI 1.37-3.92; P < .001) using jargon free language (OR 5.29; 95% CI 2.27-12.35; P < .001). Patient simulator assessments also showed significant improvements as did HCPs' self-assessments and ratings of their self-confidence when discussing different GEP tests with diverse patient types (P < .001). CONCLUSION: These short, intensive, interactive TARGET workshops significantly improved HCPs' communication about GEP results in ways likely to promote more informed decision-making by patients about chemotherapy.


Assuntos
Perfilação da Expressão Gênica , Genômica , Neoplasias da Mama/diagnóstico , Neoplasias da Mama/genética , Tomada de Decisões , Educação Médica , Feminino , Perfilação da Expressão Gênica/métodos , Genômica/métodos , Pessoal de Saúde , Humanos , Masculino , Razão de Chances , Médicos , Reino Unido/epidemiologia
6.
Support Care Cancer ; 26(11): 3941-3949, 2018 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-29845422

RESUMO

PURPOSE: Trials of novel drugs used in advanced disease often show only progression-free survival or modest overall survival benefits. Hypothetical studies suggest that stabilisation of metastatic disease and/or symptom burden are worth treatment-related side effects. We examined this premise contemporaneously using qualitative and quantitative methods. METHODS: Patients with metastatic cancers expected to live > 6 months and prescribed drugs aimed at cancer control were interviewed: at baseline, at 6 weeks, at progression, and if treatment was stopped for toxicity. They also completed Functional Assessment of Cancer Therapy (FACT-G) plus Anti-Angiogenesis (AA) subscale questionnaires at baseline then monthly for 6 months. RESULTS: Ninety out of 120 (75%) eligible patients participated: 41 (45%) remained on study for 6 months, 36 progressed or died, 4 had treatment breaks, and 9 withdrew due to toxicity. By 6 weeks, 66/69 (96%) patients were experiencing side effects which impacted their activities. Low QoL scores at baseline did not predict a higher risk of death or dropout. At 6-week interviews, as the side effect severity increased, patients were significantly less inclined to view the benefit of cancer control as worthwhile (X2 = 50.7, P < 0.001). Emotional well-being initially improved from baseline by 10 weeks, then gradually returned to baseline levels. CONCLUSION: Maintaining QoL is vital to most patients with advanced cancer so minimising treatment-related side effects is essential. As side effect severity increased, drugs that controlled cancer for short periods were not viewed as worthwhile. Patients need to have the therapeutic aims of further anti-cancer treatment explained honestly and sensitively.


Assuntos
Drogas em Investigação/uso terapêutico , Neoplasias/tratamento farmacológico , Neoplasias/psicologia , Percepção , Qualidade de Vida , Adulto , Idoso , Idoso de 80 Anos ou mais , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Atitude Frente a Saúde , Progressão da Doença , Intervalo Livre de Doença , Feminino , Humanos , Imunoterapia , Masculino , Pessoa de Meia-Idade , Metástase Neoplásica , Neoplasias/epidemiologia , Neoplasias/patologia , Inquéritos e Questionários , Resultado do Tratamento
8.
Support Care Cancer ; 25(1): 237-244, 2017 01.
Artigo em Inglês | MEDLINE | ID: mdl-27619389

RESUMO

PURPOSE: The use of novel and often expensive drugs offering limited survival benefit in advanced disease is controversial. Treatment recommendations are influenced by patient characteristics and trial data showing overall response rates (ORR), progression-free survival (PFS) and overall survival (OS). PFS is frequently the primary outcome in licencing studies. PATIENTS AND METHODS: As part of a longitudinal study Assessing the 'VALue' to patients of PROgression Free Survival (AVALPROFS), oncologists completed checklists at baseline following consultations with patients. Questions probed perceived clinical benefits of the drugs to populations in general. Patients completed study-specific interview schedules at baseline, 6 weeks into treatment, and at withdrawal due to toxicity or progression. Patients also completed tumour- and treatment-specific quality of life questionnaires monthly for their time in the study. Only baseline results are reported here. RESULTS: Thirty-two UK oncologists discussed management options with 90 patients with heterogeneous advanced cancers. Oncologists' estimates of medical benefit in general from treatment varied between 10 and 80 %. They expected 46/90 (51 %) of their patients to derive some clinical benefit from the prescribed treatment but were either unsure or expected none for 44/90 (49 %). Predictions of life expectancy were variable but 62 % (56/90) of patients were expected to survive longer with treatment. A majority of patients 51/90 (57 %) had 'no idea' or were 'unclear' what PFS meant and 45/90 (50 %) thought extension of life was the primary therapeutic aim of treatment. CONCLUSION: Discussions between doctors and patients with metastatic disease about future management plans and likely therapeutic gains are challenging. Factors influencing decisions about putative benefits of novel drugs are often applied inconsistently can be overly optimistic and may even contradict published data.


Assuntos
Antineoplásicos/administração & dosagem , Neoplasias/tratamento farmacológico , Neoplasias/psicologia , Oncologistas/psicologia , Adulto , Idoso , Tomada de Decisões , Intervalo Livre de Doença , Feminino , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Qualidade de Vida
9.
Ann Oncol ; 27(11): 2046-2052, 2016 11.
Artigo em Inglês | MEDLINE | ID: mdl-27502725

RESUMO

BACKGROUND: The randomised phase III TANIA trial demonstrated that continuing bevacizumab with second-line chemotherapy for locally recurrent/metastatic breast cancer (LR/mBC) after progression on first-line bevacizumab-containing therapy significantly improved progression-free survival (PFS) compared with chemotherapy alone [hazard ratio (HR) = 0.75, 95% confidence interval (CI) 0.61-0.93]. We report final results from the TANIA trial, including overall survival (OS) and health-related quality of life (HRQoL). PATIENTS AND METHODS: Patients with HER2-negative LR/mBC that had progressed on or after first-line bevacizumab plus chemotherapy were randomised to receive standard second-line chemotherapy either alone or with bevacizumab. At second progression, patients initially randomised to bevacizumab continued bevacizumab with their third-line chemotherapy, but those randomised to chemotherapy alone were not allowed to cross over to receive third-line bevacizumab. The primary end point was second-line PFS; secondary end points included third-line PFS, combined second- and third-line PFS, OS, HRQoL and safety. RESULTS: Of the 494 patients randomised, 483 received second-line therapy; 234 patients (47% of the randomised population) continued to third-line study treatment. The median duration of follow-up at the final analysis was 32.1 months in the chemotherapy-alone arm and 30.9 months in the bevacizumab plus chemotherapy arm. There was no statistically significant difference between treatment arms in third-line PFS (HR = 0.79, 95% CI 0.59-1.06), combined second- and third-line PFS (HR = 0.85, 95% CI 0.68-1.05) or OS (HR = 0.96, 95% CI 0.76-1.21). Third-line safety results showed increased incidences of proteinuria and hypertension with bevacizumab, consistent with safety results for the second-line treatment phase. No differences in HRQoL were detected. CONCLUSIONS: In this trial, continuing bevacizumab beyond first and second progression of LR/mBC improved second-line PFS, but no improvement in longer term efficacy was observed. The second-line PFS benefit appears to be achieved without detrimentally affecting quality of life. CLINICALTRIALSGOV: NCT01250379.


Assuntos
Anticorpos Monoclonais Humanizados/administração & dosagem , Bevacizumab/administração & dosagem , Neoplasias da Mama/tratamento farmacológico , Recidiva Local de Neoplasia/tratamento farmacológico , Adulto , Idoso , Neoplasias da Mama/genética , Neoplasias da Mama/patologia , Progressão da Doença , Intervalo Livre de Doença , Feminino , Humanos , Pessoa de Meia-Idade , Metástase Neoplásica , Recidiva Local de Neoplasia/genética , Recidiva Local de Neoplasia/patologia , Qualidade de Vida , Receptor ErbB-2/genética
10.
Support Care Cancer ; 24(11): 4471-3, 2016 11.
Artigo em Inglês | MEDLINE | ID: mdl-27470260

RESUMO

The majority of men treated for prostate cancer will eventually develop castrate-resistant disease (CRPC) with metastases (mCRPC). There are several options for further treatment: chemotherapy, third-line hormone therapy, radium, immunotherapy, and palliation. Current ASCO guidelines for survivors of prostate cancer recommend that an individual's information needs at all stages of disease are assessed and that patients are provided with or referred to the appropriate sources for information and support. Earlier reviews have highlighted the dearth of such services and we wished to see if the situation had improved more recently. Unfortunately, we conclude that there is still a lack of good-quality congruent information easily accessible specifically for men with mCRPC and insufficient data regarding the risks, harms, and benefits of different management plans. More research providing a clear evidence base about treatment consequences using patient reported outcome measures is required.


Assuntos
Tomada de Decisões/ética , Comportamento de Busca de Informação/ética , Neoplasias de Próstata Resistentes à Castração/terapia , Humanos , Masculino , Neoplasias de Próstata Resistentes à Castração/patologia
13.
Climacteric ; 18(1): 94-8, 2015 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-25029389

RESUMO

OBJECTIVES: Sexual dysfunction is a known complication of treatment for many cancers, but there have been relatively few studies investigating outcomes for ovarian cancer survivors. We have previously reported that women treated for ovarian cancer experience persistent psychological and physical problems. Sexual functioning was highlighted as a significant factor and we sought to investigate this further. METHODS: Women were invited to complete a questionnaire using both paper and online response formats. A validated tool, the Sexual Activity Questionnaire, was used to obtain information from women following a diagnosis of ovarian cancer. RESULTS: Across all responders (n = 102, mean age 51.3 years), 63% of women reported their ovarian cancer diagnosis had negatively changed their sex life. The most common reasons given for an absence of sexual activity were a lack of interest in sex, physical problems that prevented sex or no partner. Of the 46% of responders who stated they were sexually active, 77% reported pain or discomfort during intercourse and 87% described vaginal dryness. CONCLUSION: For the majority of women, treatment for ovarian cancer negatively impacts on their sex lives. Many of the symptoms described by participants are potentially reversible and clinicians should be open to raising the issue of sexual functioning with their patients.


Assuntos
Coito/fisiologia , Neoplasias Ovarianas/complicações , Comportamento Sexual/psicologia , Disfunções Sexuais Fisiológicas/etiologia , Sobreviventes/psicologia , Adolescente , Adulto , Idoso , Feminino , Humanos , Internet , Pessoa de Meia-Idade , Qualidade de Vida , Inquéritos e Questionários , Adulto Jovem
14.
Ann Oncol ; 25(10): 1979-1987, 2014 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-25070545

RESUMO

BACKGROUND: Patients with HER2-positive early breast cancer (EBC) preferred subcutaneous (s.c.) trastuzumab, delivered via single-use injection device (SID), over the intravenous (i.v.) formulation (Cohort 1 of the PrefHer study: NCT01401166). Here, we report patient preference, healthcare professional satisfaction, and safety data pooled from Cohort 1 and also Cohort 2, where s.c. trastuzumab was delivered via hand-held syringe. PATIENTS AND METHODS: Patients were randomized to receive four adjuvant cycles of 600 mg fixed-dose s.c. trastuzumab followed by four cycles of standard i.v. trastuzumab, or vice versa. The primary endpoint was overall preference proportions for s.c. or i.v., assessed by patient interviews in the evaluable ITT population. RESULTS: A total of 245 patients were randomized to receive s.c. followed by i.v. and 243 received i.v. followed by s.c. (evaluable ITT populations: 235 and 232 patients, respectively). s.c. was preferred by 415/467 [88.9%; 95% confidence interval (CI) 85.7-91.6; P < 0.0001; two-sided test against null hypothesis of 65% s.c. preference]; 45/467 preferred i.v. (9.6%; 95% CI 7-13); 7/467 indicated no preference (1.5%; 95% CI 1-3). Clinician-reported adverse events occurred in 292/479 (61.0%) and 245/478 (51.3%) patients during the pooled s.c. and i.v. periods, respectively (P < 0.05; 2 × 2 χ(2)); 16 patients (3.3%) in each period experienced grade 3 events; none were grade 4/5. CONCLUSIONS: PrefHer revealed compelling and consistent patient preferences for s.c. over i.v. trastuzumab, regardless of SID or hand-held syringe delivery. s.c. was well tolerated and safety was consistent with previous reports, including the HannaH study (NCT00950300). No new safety signals were identified compared with the known i.v. profile in EBC. PrefHer and HannaH confirm that s.c. trastuzumab is a validated and preferred option over i.v. for improving patients' care in HER2-positive breast cancer. CLINICALTRIALSGOV REGISTRATION NUMBER: NCT01401166.


Assuntos
Anticorpos Monoclonais Humanizados/administração & dosagem , Neoplasias da Mama/tratamento farmacológico , Infusões Intravenosas , Injeções Subcutâneas , Adulto , Idoso , Neoplasias da Mama/epidemiologia , Neoplasias da Mama/patologia , Estudos de Coortes , Intervalo Livre de Doença , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Receptor ErbB-2/genética , Trastuzumab , Resultado do Tratamento
15.
Breast Cancer Res Treat ; 148(3): 581-90, 2014 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-25395314

RESUMO

Neoadjuvant endocrine therapy is an alternative to chemotherapy for women with oestrogen receptor (ER)-positive early breast cancer (BC). We aimed to assess feasibility of recruiting patients to a study comparing chemotherapy versus endocrine therapy in postmenopausal women with ER-rich primary BC, and response as well as translational endpoints were assessed. Patients requiring neoadjuvant therapy were randomised to chemotherapy: 6 × 3-weekly cycles FE100C or endocrine therapy: letrozole 2.5 mg, daily for 18-23 weeks. Primary endpoints were recruitment feasibility and tissue collection. Secondary endpoints included clinical, radiological and pathological response rates, quality of life and translational endpoints. 63/80 patients approached were eligible, of those 44 (70, 95% CI 57-81) were randomised. 12 (54.5, 95% CI 32.2-75.6) chemotherapy patients showed radiological objective response compared with 13 (59.1, 95% CI 36.4-79.3) letrozole patients. Compared with baseline, mean Ki-67 levels fell in both groups at days 2-4 and at surgery [fold change: 0.24 (95% CI 0.12-0.51) and 0.24; (95% CI 0.15-0.37), respectively]. Plasma total cfDNA levels rose from baseline to week 8 [fold change: chemotherapy 2.10 (95% CI 1.47-3.00), letrozole 1.47(95% CI 0.98-2.20)], and were maintained at surgery in the chemotherapy group [chemotherapy 2.63; 95% CI 1.56-4.41), letrozole 0.95 (95% CI 0.71-1.26)]. An increase in plasma let-7a miRNA was seen at surgery for patients with objective radiological response to chemotherapy. Recruitment and tissue collection endpoints were met; however, a larger trial was deemed unfeasible due to slow accrual. Both regimens were equally efficacious. Dynamic changes were seen in Ki-67 and circulating biomarkers in both groups with increases in cfDNA and let-7a miRNA persisting until surgery for chemotherapy patients.


Assuntos
Antineoplásicos Hormonais/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Inibidores da Aromatase/administração & dosagem , Neoplasias da Mama/tratamento farmacológico , Terapia Neoadjuvante , Adulto , Antineoplásicos Hormonais/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Inibidores da Aromatase/efeitos adversos , Neoplasias da Mama/sangue , Neoplasias da Mama/patologia , Intervalo Livre de Doença , Feminino , Humanos , Letrozol , MicroRNAs/sangue , Pessoa de Meia-Idade , Nitrilas/administração & dosagem , Pós-Menopausa , Qualidade de Vida , Receptores de Estrogênio/metabolismo , Triazóis/administração & dosagem
16.
BJOG ; 121(9): 1071-9, 2014 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-24865441

RESUMO

OBJECTIVE: To examine the psychological sequelae associated with abnormal screening in the United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). DESIGN: Prospective, longitudinal randomised control trial. SETTING: Sixteen UKCTOCS centres. SAMPLE: Women aged 50-70 years randomised to annual multimodal screening, ultrasound screening or control groups. METHODS: Two groups were followed for 7 years: (1) a random sample (n = 1339), taken from all three study groups; and (2) an events sample (n = 22,035) of women with abnormal screens resulting in the need for repeat testing of either low or higher level intensity. MAIN OUTCOME MEASURES: Patient-reported measures of anxiety (scores ranging from 20 to 80) and psychological morbidity. RESULTS: In the random sample the mean difference between anxiety scores after a repeat screening and those following an annual screening was 0.4 (95% CI -0.46, 1.27), and in the events sample it was 0.37 (95% CI 0.23, 0.51). The risk of psychological morbidity was only increased in the event sample for women requiring higher level repeat screening (OR 1.28; 95% CI 1.18, 1.39). The risk of psychological morbidity in women with ovarian cancer was higher at both 6 weeks (OR 16.2; 95% CI 9.19, 28.54) and 6 months (OR 3.32; 95% CI 1.91, 5.77) following surgery. CONCLUSIONS: Screening does not appear to raise anxiety but psychological morbidity is elevated by more intense repeat testing following abnormal annual screens, and in women after surgical treatment for ovarian cancer.


Assuntos
Ansiedade/psicologia , Detecção Precoce de Câncer/psicologia , Programas de Rastreamento/psicologia , Neoplasias Ovarianas/psicologia , Idoso , Feminino , Procedimentos Cirúrgicos em Ginecologia/psicologia , Humanos , Pessoa de Meia-Idade , Neoplasias Ovarianas/diagnóstico , Neoplasias Ovarianas/cirurgia , Estudos Prospectivos , Fatores de Risco , Autorrelato , Reino Unido
17.
Br J Cancer ; 108(7): 1402-7, 2013 Apr 16.
Artigo em Inglês | MEDLINE | ID: mdl-23511558

RESUMO

BACKGROUND: Recruitment of patients into randomised clinical trials (RCTs) is essential for treatment evaluation. Appreciation of the barriers and drivers towards participation is important for trial design, communication and information provision. METHOD: As part of an intervention to facilitate effective multidisciplinary team communication about RCTs, cancer patients completed two study-specific questionnaires following trial discussions. One questionnaire examined reasons why patients accepted or declined trial entry, the other perceptions about their health-care professionals' (HCPs) information giving. RESULTS: Questionnaires were completed by 74% (358/486) of patients approached; of these 81% (291/358) had joined an RCT, 16% (56/358) had declined and 3% (11/358) were undecided. Trial participation status of the 128 patients not returning questionnaires is unknown. Trial acceptance was not dependent on disease stage, tumour type, sex or age. Satisfaction with trial information and HCPs' communication was generally very good, irrespective of participation decisions. The primary reason given for trial acceptance was altruism (40%; 110/275), and for declining, trust in the doctor (28%; 12/43). Decliners preferred doctors to choose their treatment rather than be randomised (54% vs 39%; P<0.027). Acceptors were more likely to perceive doctors as wanting them to join trials (54% vs 30%; P<0.001). Trial type, that is, standard treatment vs novel or different durations of treatment, also influenced acceptance rates. CONCLUSION: The drivers and barriers to trial participation are partly related to trial design. Unease about randomisation and impact of duration on treatment efficacy are barriers for some. Altruism and HCPs' perceived attitudes are powerful influencing factors.


Assuntos
Neoplasias/psicologia , Neoplasias/terapia , Aceitação pelo Paciente de Cuidados de Saúde/psicologia , Participação do Paciente/psicologia , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/psicologia , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Seleção de Pacientes , Inquéritos e Questionários
18.
Br J Cancer ; 108(11): 2264-71, 2013 Jun 11.
Artigo em Inglês | MEDLINE | ID: mdl-23652312

RESUMO

BACKGROUND: Most patients presenting with advanced ovarian cancer (AOC) eventually relapse. Symptom palliation, maintenance of quality of life (QoL) and prolongation of life are primary therapeutic goals. METHODS: Sixty-six U.K. oncologists completed an online survey about AOC management. Two hundred and two patients were interviewed about care, treatment experiences and expectations. RESULTS: Prior to diagnosis, 34% (69 out of 202) of women had > or =3 symptoms associated with AOC. Twenty-one per cent (43 out of 202) thought poor symptom recognition by general practitioners (GPs) delayed diagnosis. Amelioration of side effects experienced was variable, for example, only 54% (68 out of 127) distressed by alopecia had received sufficient information about it. Clinicians were asked 'What minimum gain in progression-free survival (PFS) would make you feel it worthwhile to offer maintenance therapy?'; 48% (24 out of 50) indicated 5-6 months, but 52% (26 out of 50) believed patients would find PFS of 3-4 months acceptable. When patients were presented with hypothetical scenarios, 33% (52 out of 160) would require 1-2 months extra life, 6% (10 out of 160) 3-4 months, 31% (49 out of 160) 5-6 months, and 31% (49 out of 160) > or =7 months. However, 86% (173 out of 202) would accept treatment that improved QoL without prolongation of life. When asked what was most important, 33% (67 out of 201) said QoL, 9% (19 out of 201) length of life and 57% (115 out of 201) said both were equally important. CONCLUSION: Clinicians' and patients' experiences, expectations and priorities about OC management may differ.


Assuntos
Neoplasias Ovarianas/terapia , Aceitação pelo Paciente de Cuidados de Saúde , Padrões de Prática Médica , Intervalo Livre de Doença , Feminino , Humanos , Masculino , Oncologia/estatística & dados numéricos , Pessoa de Meia-Idade , Qualidade de Vida , Inquéritos e Questionários , Taxa de Sobrevida , Reino Unido
20.
Ann Oncol ; 24(5): 1211-9, 2013 May.
Artigo em Inglês | MEDLINE | ID: mdl-23334117

RESUMO

BACKGROUND: As few older women with breast cancer receive adjuvant chemotherapy, we examined the barriers and perceptions of 24 UK NHS multidisciplinary breast cancer teams to offering this treatment to women ≥70 years. PATIENTS AND METHODS: Questionnaires regarding 803 patients with newly diagnosed breast cancer were completed by specialist teams following discussion or outpatient consultation. RESULTS: Of 803 patients, 116 (14%), all <85 years, were offered chemotherapy and 66 (8%) received it. Only 94 of 309 (30%) of women with high-risk disease were offered chemotherapy, and 53 (17%) received it. The most common reasons for not offering chemotherapy were 'other treatments more appropriate' (usually patients with ER-positive tumours) or 'benefits too small' (63% and 54% of patients, respectively). Co-morbidities and frailty were less common reasons but became more frequent with increasing age. Recommendations regarding chemotherapy were made in the absence of documented HER2 and performance status in 29% and 33%, respectively. Treatment offered varied considerably between cancer centres. CONCLUSIONS: National guidelines need development describing the minimally acceptable data for decision making, incorporating objective fitness measures and specific treatment recommendations. Such guidelines will require educational support for implementation but should standardise care and improve chemotherapy uptake in this increasing population of older patients.


Assuntos
Neoplasias da Mama/tratamento farmacológico , Quimioterapia Adjuvante , Tomada de Decisões , Idoso , Idoso de 80 Anos ou mais , Envelhecimento , Feminino , Humanos , Corpo Clínico , Inquéritos e Questionários , Suspensão de Tratamento
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