Breathless Patients With Any Established Underlying Medical DiagnosisPhase 3NCT01165034
Development of King's College Hospital Breathlessness Service
A Phase 3 study testing Breathlessness Support Service in people with Breathless Patients With Any Established Underlying Medical Diagnosis, run by King's College London at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 90 years
- Conditions the study is for
- Breathless Patients With Any Established Underlying Medical Diagnosis
- What is being tested?
- Breathlessness Support Service
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2010to May 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with breathlessness of unknown cause.
- Chronic hyperventilation syndrome.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development,Effectiveness and Cost-effectiveness of a New Respiratory and Palliative Care Out-patient Breathlessness Support Service
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.
Read more
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.
- Being tested
- Breathlessness Support Service
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathlessness Support ServiceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Best usual practice including general respiratory specialist and primary care |
| Breathlessness Support Service | Experimental | 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. Receives: Other: Breathlessness Support Service |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic Respiratory Disease Questionnaire (CRQ)
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).
Measured: 12 weeks
Secondary outcomes (9)
Hospital Anxiety and Depression Score
Measured: Baseline, 6 and 12 weeks during / after the intervention or usual care
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.
Measured: Baseline and 12 weeks post intervention or usual care
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.
Measured: Baseline, 6 and 12 weeks during / after the intervention or usual care
EQ5D will be used as a generic health related QOL measure.
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.
Measured: Baseline, 6 and 12 weeks during / after the intervention or usual care
A subset of patients (10 patients in each treatment group) will undergo qualitative interviews on expectations, and fears about the service.
Measured: Baseline, 6 and 12 weeks during / post intervention or usual care
Carer burden will be assessed using the Zarit Burden Inventory.
Measured: Baseline, 6, and 12 weeks during / post intervention or usual care
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
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.
Measured: Baseline, 6 and 12 weeks during / post intervention or usual care
Physiological status will include forced expiratory volume in 1s, slow vital capacity, peak expiratory flow rate (PEF), and pulse oximetry
Measured: Baseline, 6 and 12 weeks durning / post intervention or usual care
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).
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.
Measured: Baseline, 6 and 12 weeks durning / post intervention or usual care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionOct 2012
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breathless Patients With Any Established Underlying Medical DiagnosisStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, King's College Hospital NHS Trust
- Responsible party
- Principal investigator, Irene J Higginson, King's College London
- Investigators
- John Moxham, MD FRCP, Study director, King's College LondonIrene Higginson, BMedSci BMBS PhD FFPHM FRCP, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01165034
- Sponsor's protocol ID
- 10/H0808/17
- Status last verified
- Apr 2013
- First submitted
- 15 Jul 2010
- Last updated
- 10 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Higginson IJ, Bausewein C, Reilly CC, Gao W, Gysels M, Dzingina M, McCrone P, Booth S, Jolley CJ, Moxham J. An integrated palliative and respiratory care service for patients with advanced disease and refractory breathlessness: a randomised controlled trial. Lancet Respir Med. 2014 Dec;2(12):979-87. doi: 10.1016/S2213-2600(14)70226-7. Epub 2014 Oct 29.
PubMed 25465642Bausewein C, Jolley C, Reilly C, Lobo P, Kelly J, Bellas H, Madan P, Panell C, Brink E, De Biase C, Gao W, Murphy C, McCrone P, Moxham J, Higginson IJ. Development, effectiveness and cost-effectiveness of a new out-patient Breathlessness Support Service: study protocol of a phase III fast-track randomised controlled trial. BMC Pulm Med. 2012 Sep 19;12:58. doi: 10.1186/1471-2466-12-58.
PubMed 22992240
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development,Effectiveness and Cost-effectiveness of a New Respiratory and Palliative Care Out-patient Breathlessness Support Service
- ClinicalTrials.gov ID
- NCT01165034
- Acronym / sponsor ID
- 10/H0808/17
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, King's College Hospital NHS Trust
- Study start
- Jul 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- May 2013 (estimated)
- First posted
- 19 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Best usual practice including general respiratory specialist and primary care |
| Breathlessness Support Service | Experimental | Other: Breathlessness Support ServicePatients 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. |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with breathlessness of unknown cause.
- Chronic hyperventilation syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathlessness Support ServicePatients 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 |
Primary outcome
Chronic Respiratory Disease Questionnaire (CRQ)
Time frame: 12 weeks
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).
9 secondary outcomes
Hospital Anxiety and Depression Score
Time frame: Baseline, 6 and 12 weeks during / after the intervention or usual care
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
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
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
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
Carer burden will be assessed using the Zarit Burden Inventory.
Time frame: Baseline, 6, and 12 weeks during / post intervention or usual care
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2013.
- Derived from this study: PubMed 25465642Higginson IJ, Bausewein C, Reilly CC, Gao W, Gysels M, Dzingina M, McCrone P, Booth S, Jolley CJ, Moxham J. An integrated palliative and respiratory care service for patients with advanced disease and refractory breathlessness: a randomised controlled trial. Lancet Respir Med. 2014 Dec;2(12):979-87. doi: 10.1016/S2213-2600(14)70226-7. Epub 2014 Oct 29.
- Derived from this study: PubMed 22992240Bausewein C, Jolley C, Reilly C, Lobo P, Kelly J, Bellas H, Madan P, Panell C, Brink E, De Biase C, Gao W, Murphy C, McCrone P, Moxham J, Higginson IJ. Development, effectiveness and cost-effectiveness of a new out-patient Breathlessness Support Service: study protocol of a phase III fast-track randomised controlled trial. BMC Pulm Med. 2012 Sep 19;12:58. doi: 10.1186/1471-2466-12-58.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Moxham, MD FRCP study director
King's College London
Irene Higginson, BMedSci BMBS PhD FFPHM FRCP principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Breathlessness Support Service in people with Breathless Patients With Any Established Underlying Medical Diagnosis, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic Respiratory Disease Questionnaire (CRQ) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01165034, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2013.