A randomised double-blind multi-site parallel arm controlled trial to assess relief of refractory breathlessness comparing oral sertraline and placebo.

Palliative Care Clinical Studies Collaborative (PaCCSC)

Dataset description

Data set includes: 223 participants were included in the intention-to-treat analysis (112 receiving sertraline and 111 receiving Placebo). Treatment period over 28 days with follow-up fortnightly for 4 weeks when possible. Data available for demographic, medical history data, concurrent medications, and baseline clinical measures. Primary outcome data measured by average breathlessness on 100mm visual analogue scale and safety and toxicity data measured using the NCI CTCAE V4.0. Other data for secondary analysis include; Australia-modified Karnofsky Performance Status, spirometry., pulse oximetry, resting respiratory rate, pathology measures including full blood count, electrolyte function, renal function and serum sodium; global impression of change, blinded patient preference for symptomatic and net benefit, MRC dyspnoea scale, CRQ dyspnoae subscale, EORTC- QLQ-15 and CQOLC, measures of lifespace, HADS, breathlessness intensity and the degree to which it is unpleasant using VAS and four point Likert scales; dyspnoea scores for worst dyspnoea in the previous day measured on 0-10 NRS and a four point Likert scale; severity ranking of dyspnoea target symptoms on Likert scales; functional impairment scores on the MRC categorical scale; Healthcare utilisation including number of inpatient admissions and days spent in hospital by level of dependency (low, medium, high), home care palliative care team visits, general practitioner visits, participant preference for where they prefer to be cared for given their current health state.
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