Phase III Randomized Controlled Trial of a Breathlessness Intervention Service for Intractable Breathlessness.
Trial Snapshot
- Phase
- Phase 3
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Numerical rating Scale (NRS) for distress due to breathlessness
Study Overview
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:
- Is BIS more effective than standard care for patients with intractable breathlessness from advanced malignant or non-malignant disease?
- Does it reduce patient and carer distress due to breathlessness, and increase patients' sense of mastery of the symptom?
- What are the experiences and views of those who use BIS, their informal carers and the clinicians who refer to it?
- Does BIS offer value for money for the NHS?
Detailed Description
Research questions:
- Is BIS more effective than standard care for patients with intractable breathlessness from advanced malignant or non-malignant disease?
- Does it reduce patient & carer distress due to breathlessness, & increase patients' sense of mastery of the symptom?
- What are the experiences & views of those who use BIS, their informal carers & the clinicians who refer to it?
- 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 when their group allocation was blinded to the researcher) will be treated as before/after data & not RCT data. This will allow the collection of qualitative data from this group at the midpoint of using BIS.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient inclusion criteria:
- •appropriate referral to BIS
- •aged 18 years+
- •any patient not meeting any exclusion criteria.
- •Carer inclusion criteria:
- •informal carers (significant others, relatives, friends or neighbors) of Phase III RCT recruits
- •aged 18 years+
- •any carer not meeting any exclusion criteria.
Exclusion Criteria
- •unable to give informed consent
- •previously used BIS
- •demented/confused
- •learning difficulties
- •other vulnerable groups e.g. head injury, severe trauma, mental illness
- •not meeting all inclusion criteria.
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- NRS Breathlessness at best/worst(as for primary outcome measure)
- Modified BORG(As for primary outcome measure)
- Dyspnoea descriptors(as for primary outcome measure)
- CRQ(as for primary outcome measure)
- EQ-5D(as for primary outcome measure)
- HADS(as for primary outcome measure)
- CSRI(as for primary outcome measure)
- Charlson Co-morbidity score(as for primary outcome measure)
- Social Functioning(as for primary outcome measure)
- Karnofsky(as for primary outcome measure)
- Experience of breathlessness and expectations/views of BIS(as for primary outcome measure)
- Burden interview and caregiver Appr scale(as for primary outcome measure)