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. 2017 Jul 17;7(7):e018100. doi: 10.1136/bmjopen-2017-018100

Table 1.

The five stages of the BEAMS study

Time period Detail
Stage 0 2 days Baseline assessments:
  • Diary entries for 2 days to provide stable baseline data and to become accustomed to data collection tools

  • Baseline demographic data, physical assessment, research team mediated questionnaires, assessments and testing

  • Fitbit assessment of baseline function

  • Provided with handheld fan and practical advice on managing breathlessness

Stage 1 1 week First randomisation:
  • Randomisation 1:1:1 to receive either placebo or 8 mg ER morphine or 16 mg ER morphine

  • Participants receiving ER morphine will also receive docusate with senna. Placebo arm will receive identical placebo laxative

  • Fitbit assessment of function

Stage 2 1 week Second randomisation:
  • While continuing in arm assigned at first randomisation, add second randomised treatment.

  • 1:1 randomisation to the addition of either placebo or 8 mg ER morphine

  • Blinded docusate with senna will replace laxative placebo for those newly randomised to receive ER morphine.

Stage 3 1 week Third randomisation:
  • While continuing in arms assigned at first and second randomisation, add third randomised treatment.

  • 1:1 randomisation to addition of either placebo or 8 mg ER morphine

  • Blinded docusate with senna will replace laxative placebo for those newly randomised to receive ER morphine.

  • Fitbit assessment of function

Stage 4 Up to 6 months Optional extension study:
  • Participant may continue blinded treatment for up to 6 months on the final dose to which they were titrated.

  • Assessments establishing long-term net effects of study medication

BEAMS, Breathlessness, Exertion And Morphine Sulfate; ER, extended release.