[Show abstract][Hide abstract] ABSTRACT: Background
Advanced cancer patients experience considerable symptoms, problems, and needs. Early referral of these patients to specialized palliative care (SPC) could offer improvements. The Danish Palliative Care Trial (DanPaCT) investigates whether patients with metastatic cancer will benefit from being referred to ‘early SPC’. DanPaCT is a multicenter, parallel-group, superiority clinical trial with 1:1 randomization. The planned sample size was 300 patients. The primary data collection for DanPaCT is finished. To prevent outcome reporting bias, selective reporting, and data-driven results, we present a detailed statistical analysis plan (SAP) for DanPaCT here.
This SAP provides detailed descriptions of the statistical analyses of the primary and secondary outcomes in DanPaCT. The primary outcome is the change in the patient’s ‘primary need’. The ‘primary need’ is a patient-individualised outcome representing the score of the symptom or problem that had the highest intensity out of seven at baseline assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Secondary outcomes are the seven scales that are represented in the primary outcome, but each scale evaluated individually for all patients, and survival. The detailed description includes chosen significance levels, models for multiple imputations, sensitivity analyses and blinding. In addition, we discuss the patient-individualized primary outcome, blinding, missing data, multiplicity and the risk of bias.
Only few trials have investigated the effects of SPC. To our knowledge DanPaCT is the first trial to investigate screening based ‘early SPC’ for patients with metastatic cancer from a broad spectrum of cancer diagnosis.
Clinicaltrials.gov identifier: NCT01348048 (May 2011).
[Show abstract][Hide abstract] ABSTRACT: Advanced cancer patients experience considerable symptoms, problems, and needs. Early referral of these patients to specialised palliative care (SPC) could improve their symptoms and problems.The Danish Palliative Care Trial (DanPaCT) investigates whether patients with metastatic cancer, who report palliative needs in a screening, will benefit from being referred to 'early SPC'.
DanPaCT is a clinical, multicentre, parallel-group superiority trial with balanced randomisation (1:1).The planned sample size is 300 patients. Patients are randomised to specialised palliative care (SPC) plus standard treatment versus standard treatment. Consecutive patients from oncology departments are screened for palliative needs with a questionnaire if they: a) have metastatic cancer; b) are 18 years or above; and c) have no prior contact with SPC. Patients with palliative needs (i.e. symptoms/problems exceeding a certain threshold) according to the questionnaire are eligible. The primary outcome is the change in the patients' primary need (the most severe symptom/problem measured with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)). Secondary outcomes are other symptoms/problems (EORTC QLQ-C30), satisfaction with health care (FAMCARE P-16), anxiety and depression (the Hospital Anxiety and Depression scale), survival, and health care costs.
Only few trials have investigated the effects of SPC. To our knowledge DanPaCT is the first trial to investigate screening based 'early SPC' for patients with a broad spectrum of cancer diagnosis.Trial registration: Current controlled Trials NCT 01348048.
BMC Palliative Care 10/2013; 12(1):37. DOI:10.1186/1472-684X-12-37 · 1.78 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: CONTEXT: Breakthrough pain is common in patients with cancer and is a significant cause of morbidity in this group of patients. OBJECTIVES: The aim of this study was to characterize breakthrough pain in a diverse population of cancer patients. METHODS: The study involved 1000 cancer patients from 13 European countries. Patients were screened for breakthrough pain using a recommended diagnostic algorithm and then questioned about the characteristics and management of their pain. RESULTS: Of the 1000 patients, 44% reported incident pain, 41.5% spontaneous pain, and 14.5% a combination. The median number of episodes was three a day. The median time to peak intensity was 10 minutes, with the median for patients with incident pain being five minutes (P < 0.001). The median duration of untreated episodes was 60 minutes, with the median for patients with incident pain being 45 minutes (P = 0.001). Eight hundred six patients stated that pain stopped them doing something, 66 that it sometimes stopped them doing something, and only 107 that it did not interfere with their activities. Patients with incident pain reported more interference with walking ability and normal work, whereas patients with spontaneous pain reported more interference with mood and sleep. As well, 65.5% of patients could identify an intervention that improved their pain (29.5%, pharmacological; 23%, nonpharmacological; 12%, combination). Regarding medications, 980 patients were receiving an opioid to treat their pain, although only 191 patients were receiving a transmucosal fentanyl product licensed for the treatment of breakthrough pain. CONCLUSION: Breakthrough cancer pain is an extremely heterogeneous condition.
Journal of pain and symptom management 03/2013; 46(5). DOI:10.1016/j.jpainsymman.2012.12.009 · 2.80 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: This study involved 320 cancer patients from four Northern European countries. Patients with breakthrough pain were questioned about the characteristics of their pain, the current management of their pain, and the acceptability/utility of alternative routes of administration. The median number of episodes was 3/day. Forty-four percent patients reported incident-type pain, 39% spontaneous-type pain, and 17% a combination of these pains. The median duration was 60 min, and the median time to peak intensity was 15 min. Three percent patients reported "mild" pain, 37% "moderate" pain, and 60% "severe" pain. Ninety percent patients stated that the pain interfered with their daily activities. All patients were using opioids as rescue medication (mainly oral morphine/oxycodone), whilst 28% patients were using non-opioids, and 50% patients were using non-pharmacological interventions. Only 55% patients took rescue medication every time they experienced breakthrough pain. Sixty-five percent patients would definitely consider using an oral transmucosal product; patients from Denmark were less likely to answer positively, and a positive response was associated with previous use of the route for breakthrough pain. Seventy-three percent patients reported regular oral problems. Forty-two percent patients would definitely consider using an intranasal product, with 26% patients stating they would definitely not use such a preparation; patients from Denmark and Sweden were less likely to answer positively, and a positive response was associated with male gender, and previous use of the route. Forty-four percent patients reported regular nasal problems. Sixty percent patients would definitely consider using a subcutaneous product, and 44% patients would definitely consider using an intrapulmonary product.
European journal of pain (London, England) 08/2011; 15(7):756-63. DOI:10.1016/j.ejpain.2010.12.004 · 2.93 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Tremendous strides have been made in the last two decades with regard to the quality of palliative care available to patients at the end of life. But progress has not been uniform, even among countries in the same region of the world. The objective of this study is to describe, in a comparative context, the current status of end-of-life palliative care in Denmark using quantitative research published in the past five years. This study's conclusions, based on a synthesis of the research, suggest that despite its well earned reputation as a generally progressive welfare state, Denmark tends to trail well behind its European neighbors when it comes to end-of-life care. Understanding the cultural forces that underlie this reality may help Danish health care professionals and policy makers overcome the barriers that stand in the way of providing state-of-the-art medical care to patients who suffer at the end of life.
Health Policy 12/2010; 103(2-3):297-304. DOI:10.1016/j.healthpol.2010.11.012 · 1.91 Impact Factor