Trial of a Breathlessness Intervention Service for Intractable Breathlessness
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|