Early specialised palliative care: interventions, symptoms, problems.

BACKGROUND: Few studies have investigated the content of interventions provided in early specialised palliative care (SPC). OBJECTIVES: To characterise the content of interventions delivered in early SPC in the Danish Palliative Care Trial (DanPaCT), a multicentre trial with six participating sites. METHODS: A retrospective qualitative and quantitative study coding all new interventions initiated by the palliative teams and documented in the medical records during the 8-week study period of DanPaCT. Interventions were categorised according to (a) symptom/problem prompting the intervention, (b) type of intervention and (c) professional(s) providing the intervention. RESULTS: In total, 145 patients were randomised to the SPC teams. According to the medical records, patients received a median of 3.5 (range 0-22) new interventions in the 8-week intervention-period from the palliative teams. For 24 (18%) of the patients there was no documented interventions in the medical records. The most frequent symptom/problems treated were pain, (100 interventions; 20% of interventions given) and impaired physical function (62; 13% of interventions given). The most frequent type of intervention was pharmacological (232; 42% of interventions given). CONCLUSIONS: This is one of the first studies to meticulously investigate the content of interventions documented in the medical records for patients receiving early SPC. Diverse symptoms were treated with many different interventions. However, a relatively low number of interventions were documented. This may explain the lack of effect in DanPaCT but also questions whether all interventions were adequately documented TRIAL REGISTRATION NUMBER: NCT01348048.

Exploratory analyses of the Danish Palliative Care Trial (DanPaCT): a randomized trial of early specialized palliative care plus standard care versus standard care in advanced cancer patients.

BACKGROUND: Early and integrated specialized palliative care is often recommended but has still only been investigated in relatively few randomized clinical trials. OBJECTIVE: To investigate the effect of early specialized palliative care plus standard care versus standard care on the explorative outcomes in the Danish Palliative Care Trial (DanPaCT). METHODS: We conducted a randomized multicentre, parallel-group clinical trial. Consecutive patients with metastatic cancer were included if they had symptoms or problems that exceeded a predefined threshold according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Outcomes were estimated as the differences between the intervention and the control groups in the change from baseline to the weighted mean of the 3- and 8-week follow-ups measured as areas under the curve. RESULTS: In total, 145 patients were randomized to early specialized palliative care plus standard care versus 152 to standard care only. Early specialized palliative care had no significant effect on any of the symptoms or problems. Of the 21 items addressing satisfaction, specialized palliative care improved the item 'overall satisfaction with the help received from the health care system' with 9 points (95% confidence interval 3.8 to 14.2, p = 0.0006) and three other items (all p < 0.05). CONCLUSION: In line with the analyses of the primary and secondary outcomes in DanPaCT, we did not find that specialized palliative care, as provided in DanPaCT, affected symptoms and problems. However, patients in the intervention group seemed more satisfied with the health care received than those in the standard care group. TRIAL REGISTRATION: NCT01348048.

Detailed statistical analysis plan for the Danish Palliative Care Trial (DanPaCT).

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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT01348048 (May 2011).

A randomised, multicentre clinical trial of specialised palliative care plus standard treatment versus standard treatment alone for cancer patients with palliative care needs: the Danish palliative care trial (DanPaCT) protocol.

BACKGROUND: 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'. METHODS/DESIGN: 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. DISCUSSION: 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 NCT01348048.

Multidimensional measurement of fatigue in advanced cancer patients in palliative care: an application of the multidimensional fatigue inventory.

To investigate the level, dimensionality, and correlates associated with fatigue in patients receiving specialist palliative care, 278 advanced cancer patients referred to a department of palliative medicine during a 2-year period were asked to complete the Multidimensional Fatigue Inventory (MFI-20), a self-assessment questionnaire measuring five dimensions of fatigue, and the Hospital Anxiety and Depression Scale. Of 267 eligible patients, 130 (49%) participated. Mean fatigue scores (0-100 scale) were very high, especially for general fatigue (81), physical fatigue (87), and reduced activity (85). Only some of the MFI-20 subscales were significantly correlated. Fatigue was not correlated with sociodemographic factors. Depressed patients had higher scores on all five subscales except physical fatigue. Anxious patients had higher levels on the mental fatigue subscale only. The variation in fatigue explained by depression varied markedly (4%-31%) among subscales. Fatigue levels were very high in this population. The lack of significant correlation between some subscales indicates that they measure different aspects of fatigue. This is also supported by the differences in associations between fatigue subscales and depression and anxiety.

Symptom priority and course of symptomatology in specialized palliative care.

The study aim was to explore which symptoms/problems cancer patients in palliative care consider most distressing, and to investigate how prioritization at first contact was associated with patient-assessed symptom intensity and change in intensity over time. Initially, 175 patients named and prioritized their five most distressing symptoms. Weekly, they completed the following self-assessment questionnaires: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30, Edmonton Symptom Assessment System, and the Hospital Anxiety and Depression Scale. Initial symptom intensity scores and weekly changes were calculated and compared with prioritization of the same symptom. Pain, fatigue, physical function, appetite, nausea/vomiting, dyspnea, and depression were the symptoms most often prioritized. Priority was associated with initial scoring of pain, appetite, nausea/vomiting, dyspnea, constipation, depression, and anxiety, but not with fatigue, physical function, role function, or inactivity. Priority was associated with change in symptom intensity for pain, reduced appetite, nausea/vomiting, and constipation. Symptom prioritization may be a useful guide to choice of treatment as well as to longitudinal symptom evaluation.

Cooperating with a palliative home-care team: expectations and evaluations of GPs and district nurses.

BACKGROUND: Palliative home-care teams often cooperate with general practitioners (GPs) and district nurses. Our aim was to evaluate a palliative home-care team from the viewpoint of GPs and district nurses. METHODS: GPs and district nurses received questionnaires at the start of home-care and one month later. Questions focussed on benefits to patients, training issues for professionals and cooperation between the home-care team and the GP/ district nurse. A combination of closed- and open-ended questions was used. RESULTS: Response rate was 84% (467/553). Benefits to patients were experienced by 91 %, mainly due to improvement in symptom management, 'security', and accessibility of specialists in palliative care. After one month, 57% of the participants reported to have learnt aspects of palliative care, primarily symptom control, and 89% of them found cooperation satisfactory. Dissatisfaction was caused mainly by lack of information from the home-care team to primary-care professionals. CONCLUSION: GPs and district nurses welcomed the palliative home-care team and most experienced benefits to patients. Strengthened communication, initiated by the home-care team would enhance cooperation.

A longitudinal study of palliative care: patient-evaluated outcome and impact of attrition.

BACKGROUND: The current article evaluated the course of patient-assessed symptomatology in specialized palliative care and tested for bias due to patient attrition in measures of initial symptomatology and treatment outcome. METHODS: Over 2 years, 267 consecutive, eligible patients were referred to a department of palliative care. Upon arrival, 201 patients consented to participate in a questionnaire-based evaluation of quality of life (QOL). Of these, 175 patients participated, and 142, 119, and 95 participated in the study at 1, 2, and 3 weeks, respectively. Weekly, participants completed the self-assessment questionnaires European Organization for Research and Treatment of Cancer QLQ-C30, Edmonton Symptom Assessment System, Hospital Anxiety and Depression Scale, and Multidimensional Fatigue Inventory. Physicians used the Mini Mental State Examination to evaluate cognitive function. Changes from the initial symptom scores for each week were calculated. Initial scoring and change after 1 week were tested for association with completion level, i.e., whether the patient completed questions at 1, 2, 3, or 4 time points. RESULTS: High initial symptom intensity and significant improvements over time were observed for pain, lack of appetite, nausea/vomiting, sleeplessness, constipation, and overall QOL/well-being. For some symptoms, initial scores were significantly higher in patients who dropped out, but the changes over the first week were not significantly different between completion levels for any symptom. CONCLUSIONS: Improvement in symptom intensity was identified. Dropout was associated with higher initial symptomatology but not with poorer outcome of palliative treatment.

Pain characteristics and treatment outcome for advanced cancer patients during the first week of specialized palliative care.

To examine pain in cancer patients referred for specialized palliative care, we described pain characteristics and medication on admission, examined changes in pain during the first week, and searched for predictors of initial pain intensity and treatment outcome. On arrival in the department (T0) and after one week (T1), pain was evaluated with the Edmonton Symptom Assessment System (ESAS) and EORTC QLQ-C30. Analgesics were recorded. We investigated the associations between initial pain scores as well as differences from T0 to T1, and clinical and sociodemographic parameters, initial medication, and medical interventions. Of 267 eligible patients, initial pain scores were obtained from 175. Initial pain scores were high, although 81% of patients received opioid treatment at T0. Bone metastases, neuropathic pain, mixed pain pathophysiology, and breakthrough pain were associated with higher initial pain scores. Pain scores decreased during the first week. No single parameter convincingly predicted a better or worse outcome of pain treatment.

Self-assessment in cancer patients referred to palliative care: a study of feasibility and symptom epidemiology.

BACKGROUND: Research in palliative care is considered difficult due to the poor health of patients. However, patient-provided data are essential for a thorough description of patient symptomatology and for the evaluation of care. METHODS: The authors examined the feasibility of a questionnaire-based study using the European Organization for Research and Treatment of Cancer quality-of-life instrument EORTC QLQ-C30, the Edmonton Symptom Assessment System (ESAS), and the Hospital Anxiety and Depression Scale (HADS) in cancer patients who were receiving palliative care. This report describes the symptomatology of participating patients and examines differences in symptomatology between patients in three palliative care functions: inpatient, outpatient, and palliative home care. RESULTS: Of 267 eligible patients who were referred to a department of palliative medicine, initial self-assessment questionnaires were obtained from 176 patients (65.9%). The 91 nonparticipants were older and had lower Karnofsky Performance status (KPS) values than the participants. Almost all participating patients suffered from impaired role function and physical function and had high levels of pain, fatigue, and other symptoms. According to the HADS, 47% of patients suffered from depression. Outpatients had better scores than inpatients and patients in palliative home care for physical function, role function, cognitive function, depression, and inactivity. CONCLUSIONS: It is possible to carry out a questionnaire-based study of symptomatology in consecutive cancer patients in palliative care, achieving rather complete data from the participants. The symptomatology in these patients was very pronounced. The questionnaires were able to detect clinically important differences between places of service.