Assessing the quality of life of patients in phase I and II anti-cancer drug trials: interviews versus questionnaires

This paper discusses two different approaches to assessing quality of life in the context of cancer clinical trial participation. Drawing on empirical evidence from a study of patients' experiences of phase I and II anti-cancer drug trial participation, the paper demonstrates how different methods of collecting data about an individual's quality of life (questionnaires and interviews) can lead to alternative conclusions about patients' trial experience and the impact of trial involvement on their quality of life. Data obtained from the quality of life questionnaires interestingly revealed no statistically significant differences in any of the scores over time while in-depth interviews uncovered something of the psychological, emotional and social impact of taking part in a clinical trial from the perspective of the patient. The paper concludes by reflecting on some of the methodological issues that arise when assessing the quality of life of patients with a life threatening disease in clinical trials.     

Preliminary Validation of an Optimally Weighted Patient-Based Utility Index by Application to Randomized Trials in Breast Cancer

ObjectivesTo optimize, apply, and validate a scoring algorithm that provides a utility index from a cancer-specific quality of life questionnaire called the Utility-Based Questionnaire-Cancer (UBQ-C) using data sets from randomized trials in breast cancer. The index is designed to reflect the perspective of cancer patients in a specific clinical context so as to best inform clinical decisions.MethodsWe applied the UBQ-C scoring algorithm to trials of chemotherapy for advanced (n = 325) and early (n = 126) breast cancer. The algorithm converts UBQ-C subscales into a subset index, and combines it with a global health status item into an overall HRQL index, which is then converted to a utility index using a power transformation. The optimal subscale weights were determined by their correlations with the global scale in the relevant data set. The validity of the utility index was tested against other patient characteristics.ResultsOptimal weights (range 0–1) for the subset index in advanced (early) breast cancer were: physical function 0.20 (0.09); social/usual activities 0.23 (0.25); self-care 0.04 (0.01); and distresses 0.53 (0.64). Weights for the overall HRQL index were health status 0.66 (0.63) and subset index 0.34 (0.37). The utility index discriminated between breast cancer that was advanced rather than early (means 0.88 vs. 0.94, P < 0.0001) and was responsive to the toxic effects of chemotherapy in early breast cancer (mean change 0.07, P < 0.0001).ConclusionsThe scoring algorithm for the UBQ-C utility index can be optimized in different clinical contexts to reflect the relative importance of different aspects of quality of life to the patients in a trial. It can be used to generate sensitive and responsive utility scores, and quality-adjusted life-years that can be used within a trial to compare the net benefit of treatments and inform clinical decision-making.     

Comparing decision making between cancer patients and the general population: thoughts, emotions, or social influence?

This study extends a risk information seeking and processing model to explore the relative effect of cognitive processing strategies, positive and negative emotions, and normative beliefs on individuals' decision making about potential health risks. Most previous research based on this theoretical framework has examined environmental risks. Applying this risk communication model to study health decision making presents an opportunity to explore theoretical boundaries of the model, while also bringing this research to bear on a pressing medical issue: low enrollment in clinical trials. Comparative analysis of data gathered from 2 telephone surveys of a representative national sample (n = 500) and a random sample of cancer patients (n = 411) indicated that emotions played a more substantive role in cancer patients' decisions to enroll in a potential trial, whereas cognitive processing strategies and normative beliefs had greater influences on the decisions of respondents from the national sample.     

乳腺癌患者生命质量的影响因素分析

目的：探讨和分析乳腺癌患者的生命质量及其影响因素。方法：采用癌症病人生活功能指数量表（FLIC）对128例现患乳腺癌患者进行生命质量的流行病学调查,对所得125份合格资料进行生命质量的评价、单因素分析和多元线性回归分析。结果：125例患者生命质量的FLIC得分均值为62．3分,95％可信区间为59．63～65．00分,因病借钱、治疗方式、手术效果是影响乳腺癌患者生命质量的主要因素。结论：普及乳腺癌的相关知识,减轻病人经济负担,加强对医务人员业务知识的培训和指导,提高乳腺癌的诊疗水平,完善医疗保健制度,有利于提高乳腺癌患者的生命质量。     

Life goals and health decisions: what will people live (or die) for?

OBJECTIVE: Quality of life may represent not just quality of health but also the degree to which an individual achieves personally meaningful extrinsic goals unrelated to life duration that are not incorporated in the standard quality-adjusted life year model. The objectives of this study are to develop a typology of life goals and explore whether goal type is related to willingness to consider trading life years or health for goals. DESIGN: . Surveys of 50 Chicago-area residents and 101 inpatients. Outcomes. Participants provided up to 5 goals. For each, they reported 1) how long the goal might take to achieve, 2) whether they would prefer a shorter lifetime with certain goal achievement to their full lifetime without goal achievement, and 3) whether they would prefer lower quality of health with certain goal achievement to their full health without goal achievement. RESULTS: Participant goals were classified by 2 investigators into 7 broad categories: family, wealth, job, education, health/fitness, travel, and personal fulfillment. Respondents in both samples were more likely to be willing to trade life years (community odds ratio [OR] = 7.39, P=0.0004; patient OR=1.82, P=0.008) or health (community OR= 5.11, P = 0.0042; patient OR = 1.83, P = 0.0498) to achieve family goals than other types of goals. CONCLUSIONS: The authors derive a manageable typology of goals that may affect medical decisions and demonstrate interrater reliability. Because willingness to trade life years varies by type of goal, typical time-tradeoff assessments may be systematically influenced by respondents' goals.     

Factors influencing surgeons' decisions in elective cosmetic surgery consultations.

BACKGROUND: Current guidelines for surgeons' decisions about whether to offer cosmetic surgery are ineffective. Therefore, surgeons have to make difficult decisions on a case-by-case basis. The authors sought to identify the patient variables that influence surgeons' decisions in practice. DESIGN: A qualitative study first delineated, from observation of consultations and interviews with surgeons and other staff, variables that might influence their decisions. Then, in a cross-sectional survey of patients seeking cosmetic surgery, the authors measured these variables and tested whether they predicted the surgeons' decisions to offer surgery. PARTICIPANTS: Participants were 6 consultant plastic surgeons who assess cosmetic surgery referrals and 276 new patients aged 16 years or older referred to these surgeons. RESULTS: The qualitative study suggested that, as well as clinical factors (the probability of a satisfactory surgical outcome and the risks v. benefits of surgery), surgery was more likely to be offered where it was of low cost (i.e., minor skin surgery), physical symptoms or dysfunction were present, and abnormality of appearance was extreme. The role of patients' quality of life was unclear. The quantitative study confirmed that the probability of surgery was increased where requests were for minor skin procedures and by abnormality of patients' appearance. In patients seeking major body procedures, surgery was less likely when patients reported poor quality of life. CONCLUSION: Surgeons' decisions about whether to offer elective cosmetic surgery follow systematic rules. By incorporating the factors that surgeons use in their decision making, more effective guidelines about elective cosmetic surgery provision than are presently available could be developed.     

Patientenorientierte Kommunikation in der Arzt-Patient-Beziehung

As a result of increasing demands for more patient-centeredness in the German health care system, physician-patient communication has been subject to transformation. Physicians are being requested to take into account their patients' communicative needs, including information, shared decision making, and emotional support, more vigorously than they had been in the past. A cooperative model of the physician-patient relationship is considered most suitable for fulfilling these needs and for empowering patients to make informed decisions regarding their own health care. However, a large body of evidence exists-particularly regarding communication between cancer patients and their doctors-that shows that patients' needs are not adequately addressed or met. This potential for optimization is all the more important because targeting patients' needs during doctor-patient communication not only improves patients' satisfaction with the communication, quality of life, and well-being, but may also produce better treatment outcomes.     

Palliative care provision for patients with chronic obstructive pulmonary disease

Chronic obstructive pulmonary disease (COPD) is a major cause of disability, morbidity and mortality in old age. Patients with advanced stage COPD are most likely to be admitted three to four times per year with acute exacerbations of COPD (AECOPD) which are costly to manage. The adverse events of AECOPD are associated with poor quality of life, severe physical disability, loneliness, and depression and anxiety symptoms. Currently there is a lack of palliative care provision for patients with advanced stage COPD compared with cancer patients despite having poor prognosis, intolerable dyspnoea, lower levels of self efficacy, greater disability, poor quality of life and higher levels of anxiety and depression. These symptoms affect patients' quality of life and can be a source of concern for family and carers as most patients are likely to be housebound and may be in need of continuous support and care. Evidence of palliative care provision for cancer patients indicate that it improves quality of life and reduces health care costs. The reasons why COPD patients do not receive palliative care are complex. This partly may relate to prognostic accuracy of patients' survival which poses a challenge for healthcare professionals, including general practitioners for patients with advanced stage COPD, as they are less likely to engage in end-of-life care planning in contrast with terminal disease like cancer. Furthermore there is a lack of resources which constraints for the wider availability of the palliative care programmes in the health care system. Potential barriers may include unwillingness of patients to discuss advance care planning and end-of-life care with their general practitioners, lack of time, increased workload, and fear of uncertainty of the information to provide about the prognosis of the disease and also lack of appropriate tools to guide general practitioners when to refer patients for palliative care. COPD is a chronic incurable disease; those in an advanced stage of the disease pursuing intensive medical treatment may also benefit from the simultaneous holistic care approach of palliative care services, medical services and social services to improve quality of end of life care.     

Assessment of the effect of palliative radiotherapy for cancer patients with intracranial metastases using EORTC-QOL-C30 questionnaire

Assessment of quality of life (QOL) is of crucial importance when assigning palliative radiotherapy of brain metastases in cancer patients. AIM: To investigate the influence of whole brain radiotherapy on brain symptoms in patients with cerebral metastases; to evaluate their quality of life before and after radiation therapy using the EORTC-QOL-C30 questionnaire, as well as its influence on patients' survival. PATIENTS AND METHODS: Sixty-five patients with various locations of the primary tumor and brain metastases were included in this study. All of them underwent radiotherapy with cobalt unit. The realized dose of the whole brain was above 30 Gy: 10 x 3 Gy or 15 x 2 Gy. The patients filled in the EORTC-QOL-C30 questionnaire before radiation, at the end of the radiotherapeutic course and a month after it. Clinical characteristics of patients before and after radiotherapy were compared and assessed. All patients were treated with radiotherapy and concurrent corticosteroid treatment. RESULTS: The mean age of the patients was 53 +/- 7.8 years and the median survival was 6.6 months for lung cancer patients and 9.8 months for breast cancer patients. Each EORTC-QOL-C30 questionnaire assessed the patients in three main aspects: functional aspects, general symptoms and global health. Improvement was reported (p < 0.001) for functional indicators and health related quality of life (HRQOL). Several symptoms did not change significantly--financial difficulties, dyspnea and diarrhea. CONCLUSIONS: Whole brain radiation of cancer patients with cerebral metastases is very well tolerated. Side effects are frequently met and can be compensated by applying steroids. The assessment of quality of life gives information on patients' improvement which is more substantial in functioning, symptoms and global health. This study is a precondition for future investigations of the effect of whole brain radiation on cancer patients' quality of life.     

俱乐部式健康教育对慢性病患者生活质量影响的Meta分析

目的 系统性评价俱乐部模式健康教育对慢性病患者生活质量影响的效果。方法 通过计算机检索Cochrane、PubMed、Web of Science、CNKI、CBM、万方、维普等数据库,查找对慢性病患者开展俱乐部模式健康教育及效果评价的随机对照试验,提取有效数据,用RevMan 5.3对结果进行Meta 分析。结果 最终共纳入6篇高质量文献,共1 331名研究对象。Meta分析结果显示,相比常规健康教育方式,俱乐部模式健康教育能明显改善患者的血生化指标(SMD=-1.45,P<0.00001),提高患者的医学应对方式(SMD=0.06,P<0.00001),对于慢性病患者生存质量也有提升(SMD=-0.70,P>0.05)。结论 相比常规健康教育方式,对慢性病患者采取俱乐部式健康教育方式能有效提高其血生化指标、医学应对能力及生存质量,值得推广。     

Quality of life and psychosocial status in stage D prostate cancer. Zoladex Prostate Cancer Study Group.

Inasmuch as treatments for advanced prostate cancer may have identical clinical outcomes but very different meanings to patients, we sought to compare the impact of surgical and medical castration (orchiectomy versus injected goserelin acetate Zoladex) on quality of life and psychosocial status. A total of 147 men with Stage D prostate cancer participated in the study: 115 selected treatment with goserelin acetate, and 32 chose orchiectomy. Quality of life, as measured by the Functional Living Index: Cancer (FLIC), improved at both the 3 and the 6 month follow-up in the goserelin acetate group (p = 0.0001), but did not change from baseline at 6 months in the orchiectomy group (p = 0.54). These findings were paralleled by improvement from baseline in psychosocial status, as measured by the Profile of Mood States (POMS), at 6 month follow-up (p = 0.01 in the goserelin acetate group versus p = 0.60 in the orchiectomy group). This investigation, which is among the first to evaluate patients' appraisals of their lives following treatment choices for advanced prostatic cancer, argues compellingly for including quality of life in assessments of therapy.     

Patients undergoing subacute rehabilitation have accurate expectations of their health-related quality of life at discharge

ABSTRACT: BACKGROUND: Expectations held by patients and health professionals may affect treatment choices and participation (by both patients and health professionals) in therapeutic interventions in contemporary patient-centered healthcare environments. If patients in rehabilitation settings overestimate their discharge health-related quality of life, they may become despondent as their progress falls short of their expectations. On the other hand, underestimating their discharge health-related quality of life may lead to a lack of motivation to participate in therapies if they do not perceive likely benefit. There is a scarcity of empirical evidence evaluating whether patients' expectations of future health states are accurate. The purpose of this study is to evaluate the accuracy with which older patients admitted for subacute in-hospital rehabilitation can anticipate their discharge health-related quality of life. METHODS: A prospective longitudinal cohort investigation of agreement between patients' anticipated discharge health-related quality of life (as reported on the EQ-5D instrument at admission to a rehabilitation unit) and their actual self-reported health-related quality of life at the time of discharge from this unit was undertaken. The mini-mental state examination was used as an indicator of patients' cognitive ability. RESULTS: Overall, 232(85%) patients had all assessment data completed and were included in analysis. Kappa scores ranged from 0.42-0.68 across the five EQ-5D domains and two patient cognition groups. The percentage of exact correct matches within each domain ranged from 69% to 85% across domains and cognition groups. Overall 40% of participants in each cognition group correctly anticipated all of their self-reported discharge EQ-5D domain responses. CONCLUSIONS: Patients admitted for subacute in-hospital rehabilitation were able to anticipate the discharge health-related quality of life on the EQ-5D instrument with a moderate level of accuracy. This finding adds to the foundational empirical work supporting joint treatment decision making and patient-centered models of care during rehabilitation following acute illness or injury. Accurate patient expectations of the impact of treatment (or disease progression) on future health-related related quality of life is likely to allow patients and health professionals to successfully target interventions to priority areas where meaningful gains can be achieved.     

Validation of a decision regret scale.

BACKGROUND: As patients become more involved in health care decisions, there may be greater opportunity for decision regret. The authors could not find a validated, reliable tool for measuring regret after health care decisions. METHODS: A 5-item scale was administered to 4 patient groups making different health care decisions. Convergent validity was determined by examining the scale's correlation with satisfaction measures, decisional conflict, and health outcome measures. RESULTS: The scale showed good internal consistency (Cronbach's alpha = 0.81 to 0.92). It correlated strongly with decision satisfaction (r = -0.40 to -0.60), decisional conflict (r = 0.31 to 0.52), and overall rated quality of life (r = -0.25 to -0.27). Groups differing on feelings about a decision also differed on rated regret: F(2, 190) = 31.1, P < 0.001. Regret was greater among those who changed their decisions than those who did not, t(175) = 16.11, P < 0.001. CONCLUSIONS: The scale is a useful indicator of health care decision regret at a given point in time.     

移动医疗应用程序干预对乳腺癌患者生活质量影响的meta分析

目的 系统评价移动医疗应用程序(mobile health application,M-health APP)干预对乳腺癌患者生活质量的影响.方法 计算机检索多个数据库,时间限定为建库-2020年3月.收集M-health APP干预对乳腺癌患者生活质量影响的随机对照研究或类实验性研究,根据研究异质性采用meta分析或...     

Application of the continual reassessment method to a phase I dose-finding trial in Japanese patients: East meets West

After cancer-related phase I dose-finding trials are completed in Western countries, further phase I trials are often conducted to determine recommended doses (RDS) for Japanese patients. This may be due to concerns about possible differences in treatment tolerability between Caucasians and Japanese. In most of these, a conventional '3 +3' cohort study design is used in making dose escalation decisions, possibly due to its relatively easy implementation. Since its proposal by O'Quigleybiet al. (1990; Biometrics, 46:33-48), the continual reassessment method (CRM) has been used increasingly in cancer-related phase I dose-finding studies as an alternative to '3 +3' designs. One of the principal advantages of applying a Bayesian CRM may be the utilization of all available prior information to estimate RDS through prior distributions that are assumed for model parameters representing the dose-toxicity relationship. In this paper, we present an application of the Bayesian CRM to a phase I dose-finding study in Japanese patients with advanced breast cancer using an informative prior elicited from clinical investigators. In some settings, it may be appropriate to use an informative prior that reflects the accurate and comprehensive previous knowledge of clinical investigators. On the other hand, for a model-based Bayesian outcome-adaptive clinical trial, it is necessary to establish sufficiently vague priors so that accumulating data dominate decisions as the amount of observed data increases. Thus, we retrospectively investigated the relative strength of the prior using a recently proposed method to compute a prior effective sample size.     

Are there systematic barriers to participation in cancer treatment trials by Aboriginal and Torres Strait Islander cancer patients in Australia?

Objective : To identify factors that may systematically reduce opportunities for Aboriginal and Torres Strait Islander Australians to participate in cancer clinical trials. Methods : Analysis of online documents from the Australia and New Zealand Clinical Trials Registry for cancer treatment trials (Phase 3, 4 or Not Applicable) with at least one Australian site, registered in 2014–2018. Results : Among 365 eligible trials, most (89%) had sites only in major cities/inner regional areas, but 39% of Aboriginal and Torres Strait Islander Australians live outside these areas. Seven cancer types accounted for 58% of cancers among Aboriginal and Torres Strait Islander people, but only 46% of trials addressed these cancers. Most trials specified exclusions relating to comorbidities/health status. A substantial minority of trials (38%) explicitly referred to investigator opinion/judgment as a relevant determinant of patient eligibility. Conclusion : Aboriginal and Torres Strait Islander patients appear to have a reduced opportunity to participate in trials because of where they live, their type of cancer and their general health status, as well as for less transparent reasons relating to investigator judgment. I mplications for public health : Greater transparency and greater scrutiny of barriers to trial participation for Aboriginal and Torres Strait Islander Australians are needed to ensure equitable access.     

Who decides about prostate cancer treatment? A qualitative study

BACKGROUND: Shared decision-making between patients and health professionals has been promoted as ethically and clinically desirable. Patients vary in their willingness to participate in decision-making, while clinicians identify practical barriers to greater participation, such as time and communication skills. A paternalistic approach to treatment decisions remains common even in an area of clinical uncertainty. The willingness of patients to participate in decision-making varies over time during the course of an illness but patients may not be given the opportunity to revisit clinical decisions with their specialists after the initial consultation. OBJECTIVES: To gain an in depth understanding of the perspectives of men recently diagnosed with localized prostate cancer, and to explore the value of decision-making models in the setting of NHS practice. METHODS: The study design was a qualitative analysis of semi-structured interviews. Nineteen men recently diagnosed with localized prostate cancer were included from patients attending a British District General Hospital. RESULTS: The interviews suggested that the respondents' treatment plans were mostly decided on their behalf by their clinicians. Whilst initially accepting this paternalistic approach, the interviewees over time wished to revisit the decisions. Patients' barriers to shared decision-making included fear of appearing disrespectful to their doctors and of taking responsibility for the outcome of treatment. The structure of patient follow-up did not afford the men an opportunity to discussion treatment decisions further. CONCLUSIONS: The paternalistic decision-making model remains the chosen approach in this situation. The patients' willingness to become actively involved in choosing their care varies over time. Barriers to shared decision-making can be identified both in the nature of the doctor-patient relationship and the structure of the clinical follow-up.     

Patients' perceptions of physicians communication and outcomes of the accrual to trial process

The purpose of this study was to examine the relations among patients' perceptions of their physicians' communicative behavior during the informed consent interview, the patient's feeling of being confirmed by the physician and satisfied with care delivered by the physician, and the patient's decision to participate in a clinical trial or not. Respondents included 130 cancer patients who were eligible for a clinical trial and who had recently discussed trial participation with their physicians. Results indicated that a linear combination of the variables physician affiliative style, physician dominant or controlling style, patient satisfaction, patient confirmation, patient preference for decision making, patient desire for information, and patient age discriminate between patients who agree to participate in clinical trials and patients who refuse to participate. Physicians' affiliative communicative behaviors and patient satisfaction were clearly important to patients who agreed to participate. Motivations for patients who declined to participate in trials were less clear. Implications for physicians who offer clinical trials to their patients are that specific communication skills may enhance their patients' satisfaction and may help increase enrollment in clinical trials.