Development of King's College Hospital Breathlessness Service

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
King's College Hospital NHS Trust
Information provided by (Responsible Party):
Irene J Higginson, King's College London
ClinicalTrials.gov Identifier:
NCT01165034
First received: July 15, 2010
Last updated: April 8, 2013
Last verified: April 2013
  Purpose

Breathlessness is a common, distressing symptom in advanced malignant and non malignant disease, and impacts significantly on quality of life. Breathlessness in end stage disease is also responsible for significant healthcare resource usage. Escalante [1] reported hospital admission rates of 60% in patients presenting to a cancer treatment centre with breathlessness. Preliminary trials of breathlessness clinics with selected groups of patients have been promising, but lack data on their cost effectiveness.

The principal aim of the research is to develop and evaluate the effectiveness and cost effectiveness of a multidisciplinary outpatient breathlessness support service (BSS) for the palliation of breathlessness, in advanced malignant and non malignant disease. This is a phase II study that aims to test the hypothesis that a BSS will improve patient mastery over breathlessness and reduce the use of healthcare resources (including GP consultations,accident and emergency attendances, and length of hospital stay) compared with usual best medical care alone (UC),at an acceptable level of cost effectiveness.The outcomes of this study will also help to determine sample size,develop and test methods for a phase III trial that will follow on from this project.

This study will run over 2 years. Breathless patients with advanced malignant and non malignant disease who have already been optimally medically managed will be eligible.

The service will be run in the outpatient department of King's College Hospital, and patients will also be assessed in their own home and by telephone interviews. At baseline we will assess respiratory function and breathlessness mastery and severity using validated scales, and health service usage. Individuals will be randomised to the intervention group [IG] (n=55) or UC (n=55). The IG will attend the new outpatient clinical service with multiprofessional input. Assessments will be repeated at 4, 10 & 24 weeks.

1.Escalante, C.P., Martin, C.G., Elting, L.S. et al., Dyspnea in cancer patients. Etiology, resource utilization, and survival implications in a managed care world. Cancer, 1996. 78(6): p. 13149.


Condition Intervention Phase
Breathless Patients With Any Established Underlying Medical Diagnosis
Other: Breathlessness Support Service
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Development,Effectiveness and Cost-effectiveness of a New Respiratory and Palliative Care Out-patient Breathlessness Support Service

Resource links provided by NLM:


Further study details as provided by King's College London:

Primary Outcome Measures:
  • Chronic Respiratory Disease Questionnaire (CRQ) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The primary outcome measure will be improvement of mastery of breathlessness, as assessed by a change in the score within the Mastery domain of the chronic respiratory disease questionnaire (CRQ).


Secondary Outcome Measures:
  • Hospital Anxiety and Depression Score [ Time Frame: Baseline, 6 and 12 weeks during / after the intervention or usual care ] [ Designated as safety issue: No ]
  • A Numerical Rating Scale (NRS) to assess the intensity of the sensation of breathlessness on average and at worst at rest and on exertion over the last 24 hours. [ Time Frame: Baseline and 12 weeks post intervention or usual care ] [ Designated as safety issue: No ]
  • Symptom related quality of life(QOL) will also be assessed using the Palliative Care Outcome Scale (POS) and POS symptoms to quantify palliative care symptoms in addition to breathlessness. [ Time Frame: Baseline, 6 and 12 weeks during / after the intervention or usual care ] [ Designated as safety issue: No ]
  • EQ5D will be used as a generic health related QOL measure. [ Time Frame: Baseline, 6 and 12 weeks during / after the intervention or usual care ] [ Designated as safety issue: No ]
    EQ5D is a standardised instrument for use as a measure of health outcome and is especially suited to cost effectivenessanalyses as it can be used to generate qualityad justed life years (QALYs). It is applicable to a wide range of health conditions and treatments, and provides a simple descriptive profile and a single index value for health status.

  • A subset of patients (10 patients in each treatment group) will undergo qualitative interviews on expectations, and fears about the service. [ Time Frame: Baseline, 6 and 12 weeks during / post intervention or usual care ] [ Designated as safety issue: No ]
  • Carer burden will be assessed using the Zarit Burden Inventory. [ Time Frame: Baseline, 6, and 12 weeks during / post intervention or usual care ] [ Designated as safety issue: No ]
  • The Client Service Receipt Inventory (CSRI) will be used to record other service use in the three month period prior to baseline assessment and then for each followup period [ Time Frame: Baseline, 6 and 12 weeks during / post intervention or usual care ] [ Designated as safety issue: No ]
    The CSRI has been used in over 200 studies to assess costs and takes approximately 20 minutes to complete. Services included will be health care (primary and secondary),medication, social care and informal care from family/friends. Lost work time for patients and carers will be recorded.

  • Physiological status will include forced expiratory volume in 1s, slow vital capacity, peak expiratory flow rate (PEF), and pulse oximetry [ Time Frame: Baseline, 6 and 12 weeks durning / post intervention or usual care ] [ Designated as safety issue: No ]
  • Respiratory muscle activity will also be measured noninvasively by quantifying the surface parasternal intercostal muscle electromyogram, to provide an index of neural respiratory drive (NRD). [ Time Frame: Baseline, 6 and 12 weeks durning / post intervention or usual care ] [ Designated as safety issue: No ]
    This measure is included because disease severity measured by spirometry alone correlates poorly with breathlessness and functional status in respiratory disease. Assessment of NRD using respiratory muscle electromyography provides a measure of the load on the respiratory system, and inclusion of this parameter will provide insights this test in the future phase III trial.


Estimated Enrollment: 110
Study Start Date: July 2010
Estimated Study Completion Date: May 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual care
Best usual practice including general respiratory specialist and primary care
Experimental: Breathlessness Support Service
Patients randomised to the intervention group (IG) will be entered into the BSS in addition to standard best usual care. Expertise in the BSS will comprise of a palliative care consultant or specialist registrar (SpR), a respiratory medicine consultant or SpR with a specialist interest in breathlessness, a respiratory physiotherapist, an occupational therapist and a respiratory nurse specialist. Patients will see 12 health professionals per visit, and multidisciplinary team meetings will take place before and after each visit. Outpatient clinics will take place once per week. The timing of interventions and data collection has been designed to allow for short disease trajectories in patients with cancer and minimise patient burden, whilst allowing time for interventions to have the desired effect. Four weeks is considered to be the minimum length of pulmonary rehabilitation programmes that give a clinically significant benefit.
Other: Breathlessness Support Service
Patients randomised to the intervention group (IG) will be entered into the BSS in addition to standard best usual care. Expertise in the BSS will comprise of a palliative care consultant or specialist registrar (SpR), a respiratory medicine consultant or SpR with a specialist interest in breathlessness, a respiratory physiotherapist, an occupational therapist and a respiratory nurse specialist. Patients will see 12 health professionals per visit, and multidisciplinary team meetings will take place before and after each visit. Outpatient clinics will take place once per week. The timing of interventions and data collection has been designed to allow for short disease trajectories in patients with cancer and minimise patient burden, whilst allowing time for interventions to have the desired effect. Four weeks is considered to be the minimum length of pulmonary rehabilitation programmes that give a clinically significant benefit.

  Eligibility

Ages Eligible for Study:   16 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with any established underlying medical diagnosis with breathlessness on exertion or at rest.
  • Cancer patients who have risk factors for breathlessness( risk factors include a history of smoking, asthma or COPD, lung irradiation, exposure to asbestos, coal dust, cotton dust or grain dust, lung involvement by cancer)
  • Respiratory muscle weakness
  • Anxiety.
  • Patients must have advanced disease that is refractory to maximal optimised medical management. - Patients must be able to engage with a short term physiotherapy and occupational therapy intervention.

Exclusion Criteria:

  • Patients with breathlessness of unknown cause.
  • Chronic hyperventilation syndrome.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01165034

Locations
United Kingdom
King's College Hospital
London, United Kingdom, SE5 9JP
Sponsors and Collaborators
King's College London
National Institute for Health Research, United Kingdom
King's College Hospital NHS Trust
Investigators
Study Director: John Moxham, MD FRCP King's College London
Principal Investigator: Irene Higginson, BMedSci BMBS PhD FFPHM FRCP King's College London
  More Information

No publications provided by King's College London

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Irene J Higginson, Professor, King's College London
ClinicalTrials.gov Identifier: NCT01165034     History of Changes
Other Study ID Numbers: 10/H0808/17
Study First Received: July 15, 2010
Last Updated: April 8, 2013
Health Authority: United Kingdom: National Health Service
United Kingdom: National Institute for Health Research
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014