Dataset Information

Symptom Control Trials in Patients With Advanced Cancer: A Qualitative Study.

ABSTRACT: CONTEXT:Symptom control research in patients with advanced cancer is not common. This may be the result of a belief that this research is unethical, not practical, or that patients are not interested. However, the experiences of cancer patients who have actually taken part in symptom control research near the end of life have never been detailed. OBJECTIVES:The objective was to explore the experiences of patients with advanced cancer who had taken part in symptom control trials. METHODS:A prospective two-center study was undertaken using grounded theory methodology. Theoretical sampling was used to recruit patients from one of two double-blind, randomized, placebo-controlled trials studying novel analgesic agents for cancer-related pain. Participants completed one semistructured interview. Recruitment and interviewing continued until data saturation was achieved. RESULTS:Twenty-one participants were recruited. Fifteen (71%) were male, with a mean age of 62 years. Key themes identified included reasons for trial participation, participants' interactions with the trial staff, and participants' responses to the effect the trial had on their pain. In general, participants regarded taking part in a clinical trial as a positive experience, and potentially improving overall well-being. Crucially, this was not related to whether there had been an improvement in symptoms. CONCLUSION:The findings provide grounds for optimism that patients with advanced cancer may benefit from taking part in symptom control trials, supporting the paradigm that participation in symptom control research should be encouraged in this population.

SUBMITTER: Middlemiss T

PROVIDER: S-EPMC4627489 | biostudies-literature | 2015 Nov

REPOSITORIES: biostudies-literature

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Symptom Control Trials in Patients With Advanced Cancer: A Qualitative Study.

Middlemiss Tom T Lloyd-Williams Mari M Laird Barry J BJ Fallon Marie T MT

Journal of pain and symptom management 20150529 5

<h4>Context</h4>Symptom control research in patients with advanced cancer is not common. This may be the result of a belief that this research is unethical, not practical, or that patients are not interested. However, the experiences of cancer patients who have actually taken part in symptom control research near the end of life have never been detailed.<h4>Objectives</h4>The objective was to explore the experiences of patients with advanced cancer who had taken part in symptom control trials.<h ...[more]

PMID: 26031710

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Project description:Introduction: Lung cancer is the deadliest and most prevalent cancer worldwide. Lung cancer treatments have different characteristics and are associated with a range of benefits and side effects for patients. Such differences may raise uncertainty among drug developers, regulators, payers, and clinicians regarding the value of these treatment effects to patients. The value of conducting patient preference studies (using qualitative and/or quantitative methods) for benefits and side effects of different treatment options has been recognized by healthcare stakeholders, such as drug developers, regulators, health technology assessment bodies, and clinicians. However, evidence-based guidelines on how and when to conduct and use these studies in drug decision-making are lacking. As part of the Innovative Medicines Initiative PREFER project, we developed a protocol for a qualitative study that aims to understand which treatment characteristics are most important to lung cancer patients and to develop attributes and levels for inclusion in a subsequent quantitative preference survey. Methods: The study protocol specifies a four-phased approach: (i) a scoping literature review of published literature, (ii) four focus group discussions with stage III and IV Non-Small Cell Lung Cancer patients, (iii) two nominal group discussions with stage III and IV Non-Small Cell Lung Cancer patients, and (iv) multi-stakeholder discussions involving clinicians and preference experts. Discussion: This protocol outlines methodological and practical steps as to how qualitative research can be applied to identify and develop attributes and levels for inclusion in patient preference studies aiming to inform decisions across the drug life cycle. The results of this study are intended to inform a subsequent quantitative preference survey that assesses patient trade-offs regarding lung cancer treatment options. This protocol may assist researchers, drug developers, and decision-makers in designing qualitative studies to understand which treatment aspects are most valued by patients in drug development, regulation, and reimbursement.

Project description:BACKGROUND:Symptom distress in patients toward the end of life can change rapidly. Family caregivers have the potential to help patients manage those symptoms, as well as their own stress, if they are equipped with the proper resources. Electronic health (eHealth) systems may be able to provide those resources. Very sick patients may not be able to use such systems themselves to report their symptoms but family caregivers could. OBJECTIVE:The aim of this paper was to assess the effects on cancer patient symptom distress of an eHealth system that alerts clinicians to significant changes in the patient's symptoms, as reported by a family caregiver. METHODS:A pooled analysis from two randomized clinical trials (NCT00214162 and NCT00365963) compared outcomes at 12 months for two unblinded groups: a control group (Comprehensive Health Enhancement Support System [CHESS]-Only) that gave caregivers access to CHESS, an online support system, and an experimental group (CHESS+CR [Clinician Report]), which also had CHESS but with a CR that automatically alerted clinicians if symptoms exceeded a predetermined threshold of severity. Participants were dyads (n=235) of patients with advanced lung, breast, or prostate cancer and their respective family caregivers from 5 oncology clinics in the United States of America. The proportion of improved patient threshold symptoms was compared between groups using area-under-the-curve analysis and binomial proportion tests. The proportion of threshold symptoms out of all reported symptoms was also examined. RESULTS:When severe caregiver-reported symptoms were shared with clinicians, the symptoms were more likely to be subsequently reported as improved than when the symptoms were not shared with clinicians (P<.001). Fewer symptom reports were completed in the group of caregivers whose reports went to clinicians than in the CHESS-Only group (P<.001), perhaps because caregivers, knowing their reports might be sent to a doctor, feared they might be bothering the clinician. CONCLUSIONS:This study suggests that an eHealth system designed for caregivers that alerts clinicians to worrisome changes in patient health status may lead to reduced patient distress. TRIAL REGISTRATION:Clinicaltrials.gov NCT00214162; https://clinicaltrials.gov/ct2/show/NCT00214162 (Archived by WebCite at http://www.webcitation.org/6nmgdGfuD) and Clinicaltrials.gov NCT00365963; https://clinicaltrials.gov/ct2/show/NCT00365963 (Archived by WebCite at http://www.webcitation.org/6nmh0U8VP).

Project description:BACKGROUND::Performance status, a predictor of cancer survival, and ability to maintain independent living deteriorate in advanced disease. Understanding predictors of performance status trajectory could help identify those at risk of functional deterioration, target support for independent living and reduce service costs. The relationship between symptoms, analgesics and performance status is poorly delineated. AIM::The aim of this study is to determine whether demographics, analgesics, disease characteristics, quality-of-life domains and C-reactive protein predict the trajectory of Karnofsky Performance Status (KPS) in patients with advanced cancer. DESIGN::The study design is the secondary data analysis of the international prospective, longitudinal European Palliative Care Cancer Symptom study (ClinicalTrials.gov: NCT01362816). A multivariable regression model was built for KPS area under the curve per day (AUC). SETTING AND PARTICIPANTS::This included adults with advanced, incurable cancer receiving palliative care, without severe cognitive impairment and who were not imminently dying ( n = 1739). RESULTS::The mean daily KPS AUC ( n = 1052) was 41.1 (standard deviation = 14.1). Opioids ( p < 0.001), co-analgesics ( p = 0.023), poorer physical functioning ( p < 0.001) and appetite loss ( p = 0.009) at baseline were explanatory factors for lower KPS AUC. A subgroup analysis of participants with C-reactive protein data ( n = 240) showed that only C-reactive protein ( p = 0.040) and physical function ( p < 0.001) were associated with lower KPS AUC. CONCLUSION::This study is novel in determining explanatory factors for subsequent functional trajectories in an international dataset and identifying systemic inflammation as a candidate therapeutic target to improve functional performance. The effect of interventions targeting physical function, appetite and inflammation, such as those used for cachexia management, on maintaining functional status in patients with advanced cancer needs to be investigated.

Project description:INTRODUCTION:While some evidence exists that real-time remote symptom monitoring devices can decrease morbidity and prevent unplanned admissions in oncology patients, overall, these studies have significant methodological weaknesses. The electronic Symptom Management using the Advanced Symptom Management System (ASyMS) Remote Technology (eSMART) study is designed to specifically address these weaknesses with an appropriately powered, repeated-measures, parallel-group stratified randomised controlled trial of oncology patients. METHODS AND ANALYSIS:A total of 1108 patients scheduled to commence first-line chemotherapy (CTX) for breast, colorectal or haematological cancer will be recruited from multiple sites across five European countries.Patients will be randomised (1:1) to the ASyMS intervention (intervention group) or to standard care currently available at each site (control group). Patients in the control and intervention groups will complete a demographic and clinical questionnaire, as well as a set of valid and reliable electronic patient-reported outcome measures at enrolment, after each of their CTX cycles (up to a maximum of six cycles) and at 3, 6, 9 and 12 months after completion of their sixth cycle of CTX. Outcomes that will be assessed include symptom burden (primary outcome), quality of life, supportive care needs, anxiety, self-care self-efficacy, work limitations and cost effectiveness and, from a health professional perspective, changes in clinical practice (secondary outcomes). ETHICS AND DISSEMINATION:Ethical approval will be obtained prior to the implementation of all major study amendments. Applications will be submitted to all of the ethics committees that granted initial approval.eSMART received approval from the relevant ethics committees at all of the clinical sites across the five participating countries. In collaboration with the European Cancer Patient Coalition (ECPC), the trial results will be disseminated through publications in scientific journals, presentations at international conferences, and postings on the eSMART website and other relevant clinician and consumer websites; establishment of an eSMART website (www.esmartproject.eu) with publicly accessible general information; creation of an eSMART Twitter Handle, and production of a toolkit for implementing/utilising the ASyMS technology in a variety of clinical practices and other transferable health care contexts. TRIAL REGISTRATION NUMBER:NCT02356081.

Dataset Information

Symptom Control Trials in Patients With Advanced Cancer: A Qualitative Study.

Publications

Symptom Control Trials in Patients With Advanced Cancer: A Qualitative Study.

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