Trial of a Breathlessness Intervention Service for Intractable Breathlessness
|ClinicalTrials.gov Identifier: NCT00678405|
Recruitment Status : Unknown
Verified June 2010 by Cambridge University Hospitals NHS Foundation Trust.
Recruitment status was: Recruiting
First Posted : May 15, 2008
Last Update Posted : June 25, 2010
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?
|Condition or disease||Intervention/treatment||Phase|
|Dyspnea||Behavioral: Breathlessness Intervention Service Behavioral: Best supportive care (Standard Care)||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Phase III Randomized Controlled Trial of a Breathlessness Intervention Service for Intractable Breathlessness.|
|Study Start Date :||August 2008|
|Estimated Primary Completion Date :||December 2010|
|Estimated Study Completion Date :||December 2010|
Active Comparator: WLm / WLnm
Best supportive care
Behavioral: Best supportive care (Standard Care)
Standard care: specialist outpatient appointments in secondary care (e.g. respiratory, cardiology, neurology or oncology) which may include specialist nurse input, and primary care services.
Other Name: Standard care
Experimental: FTm / FTnm
Breathlessness Intervention Service
Behavioral: Breathlessness Intervention Service
Breathlessness Intervention Service (BIS) consists of a clinical specialist physiotherapist & palliative care consultant. It aims to manage the symptom of breathlessness in patients with any disease (cancer & non-cancer) using a rehabilitative approach. Interventions include: evidence-based non-pharmacological interventions (psychological, social & physical); palliative care input (e.g. end of life issues, psychosocial issues, family concerns); & pharmacological review. Thus BIS seeks to enhance the self-management of breathlessness. Uniquely, care is located in clinic or in patients' own homes, as appropriate. Referrals come from medical specialists, GPs & allied health professionals (with medical consent).
Other Name: BIS
- 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) ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00678405
|Contact: Sara Booth, FRCPfirstname.lastname@example.org|
|Contact: Morag C Farquhar, PhDemail@example.com|
|Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ|
|Contact: Sara Booth, FRCP 44-12-2358-6703 firstname.lastname@example.org|
|Contact: Morag C Farquhar, PhD email@example.com|
|Principal Investigator:||Sara Booth, FRCP||Cambridge University Hospitals NHS Foundation Trust|