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A feasibility study of lorazepam for anxiety in palliative care (LORAZEPAM Study)

Version 3 2024-08-01, 05:23
Version 2 2023-05-17, 05:30
Version 1 2023-05-17, 05:14
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posted on 2024-08-01, 05:23 authored by MACH HeSANDAMACH HeSANDA, Dr Nicola Atkin, Professor Brian Le, Professor Jennifer Philip
Demographic data for 15 adult patients with advanced cancer or advanced life-limiting disease and persistent or recurrent anxiety causing clinically significant distress or functional impairment at time of enrolment. 11 patients randomised to regular lorazepam treatment arm, 4 randomised to placebo, and treated for up to 12 weeks. Data collected at baseline, week 1,2,4,8,12 and follow-up at week 16 unless early discontinuation. Data includes anxiety measures (HADS-A, PROMIS 7a short form, PGIC), functional status (AKPS), other symptoms (ESAS), health-related quality of life (EQ 5D 5L), sleepiness (ESS), other adverse events and feasibility outcome data (recruitment, retention, completion of assessments, survival, acceptability, burden).

History

Resource Type

Individual Participant Data (IPD)

Institution name

Peter MacCallum Cancer Centre

Place

Victoria, Australia

Contact Organisation

HeSANDA MACH Node

Study Identifier

https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=ACTRN12620001143910

Date Collected

2021-04-06/2022-08-01

HeSANDA Version

HeSANDA 1.0.0

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