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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.

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.

BACKGROUND: Admittance to specialized palliative care (SPC) has been discussed in the literature, but previous studies examined exclusively those admitted, not those with an assessed need for SPC but not admitted. The aim was to investigate whether admittance to SPC for referred adult patients with cancer was related to sex, age, diagnosis, geographic region or referral unit.MATERIAL AND METHODS: A register-based study with data from the Danish Palliative Care Database (DPD). From DPD we identified all adult patients with cancer, who died in 2010-2012 and who were referred to and assessed to have a need for SPC (N = 21,597).The associations were investigated using logistic regression models, which also evaluated whether time from referral to death influenced the associations.RESULTS: In the adjusted analysis, we found that admittance was higher for younger patients [e.g., 50-59 versus 80 + years: odds ratio (OR) = 2.03; 1.78-2.33]. There was lower odds of admittance for patients with hematological malignancies and patients from two regions: Capital Region of Denmark and Region of Southern Denmark. Lower admittance among men and patients referred from hospital departments was explained by later referral.CONCLUSIONS: In this first nationwide study of admittance to SPC among patients with a SPC need, we found difference in admittance according to age, diagnosis and region. This indicates that prioritization of the limited resources means that certain subgroups with a documented need have reduced likelihood of admission to SPC.

BACKGROUND: Beneficial effects of early palliative care have been found in advanced cancer, but the evidence is not unequivocal.AIM: To investigate the effect of early specialist palliative care among advanced cancer patients identified in oncology departments.SETTING/PARTICIPANTS: The Danish Palliative Care Trial (DanPaCT) (ClinicalTrials.gov NCT01348048) is a multicentre randomised clinical trial comparing early referral to a specialist palliative care team plus standard care versus standard care alone. The planned sample size was 300. At five oncology departments, consecutive patients with advanced cancer were screened for palliative needs. Patients with scores exceeding a predefined threshold for problems with physical, emotional or role function, or nausea/vomiting, pain, dyspnoea or lack of appetite according to the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) were eligible. The primary outcome was the change in each patient's primary need (the most severe of the seven QLQ-C30 scales) at 3- and 8-week follow-up (0-100 scale). Five sensitivity analyses were conducted. Secondary outcomes were change in the seven QLQ-C30 scales and survival.RESULTS: Totally 145 patients were randomised to early specialist palliative care versus 152 to standard care. Early specialist palliative care showed no effect on the primary outcome of change in primary need (-4.9 points (95% confidence interval -11.3 to +1.5 points); p = 0.14). The sensitivity analyses showed similar results. Analyses of the secondary outcomes, including survival, also showed no differences, maybe with the exception of nausea/vomiting where early specialist palliative care might have had a beneficial effect.CONCLUSION: We did not observe beneficial or harmful effects of early specialist palliative care, but important beneficial effects cannot be excluded.

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).

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'.