Clinical Trial: Trial of a Breathlessness Intervention Service for Intractable Breathlessness

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Phase III Randomized Controlled Trial of a Breathlessness Intervention Service for Intractable Breathlessness.

Brief Summary:

The aim of this study is to evaluate the impact of a Breathlessness Intervention Service (BIS) on the quality of life of patients and families affected by intractable breathlessness. The questions to be addressed by this research are:

  1. Is BIS more effective than standard care for patients with intractable breathlessness from advanced malignant or non-malignant disease?
  2. Does it reduce patient and carer distress due to breathlessness, and increase patients' sense of mastery of the symptom?
  3. What are the experiences and views of those who use BIS, their informal carers and the clinicians who refer to it?
  4. Does BIS offer value for money for the NHS?

Detailed Summary:

Research questions:

  1. Is BIS more effective than standard care for patients with intractable breathlessness from advanced malignant or non-malignant disease?
  2. Does it reduce patient & carer distress due to breathlessness, & increase patients' sense of mastery of the symptom?
  3. What are the experiences & views of those who use BIS, their informal carers & the clinicians who refer to it?
  4. Is BIS cost-effective?

To assess changes in patient outcomes attributable to BIS, a pragmatic RCT design will be conducted using a fast-track design (design proved highly acceptable at Phase II). Analysis will focus on comparing patients who have used BIS to those who have not (yet) used BIS (the use of BIS by the control group will occur subsequent to these measurement points).

The researcher will be blinded to the allocation of respondents up until discharge/referral on from BIS for FT patients or at the end of the waiting period for CC patients. This will be achieved by the researcher conducting study recruitment & collecting baseline measures before instructing a third party (local clinical trials' nurse) to conduct randomisation & reporting of allocation (to the patient & BIS) using a random sequence of opaque envelopes previously generated by a statistician independent of BIS. Subsequently, all data will be handled using study identity numbers; group allocation identifiers will only be added at analysis. This model was used successfully in the Phase II pilot trial.

Data collected from the control group once they are in receipt of BIS (after their period on the waiting list
Sponsor: Cambridge University Hospitals NHS Foundation Trust

Current Primary Outcome: Numerical rating Scale (NRS) for distress due to breathlessness [ Time Frame: End of intervention (4 weeks after baseline for patients with a non-malignant diagnosis; 2 weeks after baseline for patients with malignant diagnoses) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Modified BORG [ Time Frame: As for primary outcome measure ]
  • NRS Breathlessness at best/worst [ Time Frame: as for primary outcome measure ]
  • Dyspnoea descriptors [ Time Frame: as for primary outcome measure ]
  • CRQ [ Time Frame: as for primary outcome measure ]
  • EQ-5D [ Time Frame: as for primary outcome measure ]
  • HADS [ Time Frame: as for primary outcome measure ]
  • CSRI [ Time Frame: as for primary outcome measure ]
  • Charlson Co-morbidity score [ Time Frame: as for primary outcome measure ]
  • Social Functioning [ Time Frame: as for primary outcome measure ]
  • Karnofsky [ Time Frame: as for primary outcome measure ]
  • Experience of breathlessness and expectations/views of BIS [ Time Frame: as for primary outcome measure ]
  • Burden interview and caregiver Appr scale [ Time Frame: as for primary outcome measure ]


Original Secondary Outcome: Modified BORG; NRS breathlessness at best/worst; dyspnoea descriptors; CRQ; EQ-5D; HADS; CSRI; Charlton Co-morbidity Index; social functioning; Karnofsky; experience of breathlessness & expectations/views of BIS; Burden Interview & Caregiver Appr. Scale. [ Time Frame: as for primary outcome measure ]

Information By: Cambridge University Hospitals NHS Foundation Trust

Dates:
Date Received: May 14, 2008
Date Started: August 2008
Date Completion: December 2010
Last Updated: June 24, 2010
Last Verified: June 2010