Evaluation of a Multi-professional Breathlessness Service for Patients With Breathlessness Due to Any Advanced Disease

NCT02622412 | Completed

• 1 other identifier: 01GY1331
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

Brief Summary

Breathlessness is a common and distressing symptom in patients with advanced diseases like cancer, chronic obstructive pulmonary disease (COPD), chronic heart failure (CHF) or lung fibrosis, which broadly impacts on patients' quality of life and may result in high burden for carers. This single-blinded randomized controlled fast track trial evaluates the effectiveness of a multi-professional breathlessness service in patients with advanced and chronic diseases. The intervention group will get immediate access to the breathlessness service whereas the control group will receive standard care and get access to the service after a waiting time of eight weeks. Primary endpoints are mastery of breathlessness and quality of life, measured with the CRQ (Chronic Respiratory Questionnaire) as well as the reduction of symptom burden of patients and burden of carers. The evaluation of the cost effectiveness of the breathlessness service from the perspective of the German health system is a further study aim.

Conditions

Breathlessness; COPD; Cancer; Chronic Heart Failure; Interstitial Lung Disease

Keywords

Quality of Life; Palliative Therapy; Outpatient Services

Outcome Measures

Primary Outcomes (4)

• Mastery of breathlessness (CRQ mastery subscale)

  Change from baseline in Mastery of breathlessness (at week 8) measured with the Chronic Respiratory Disease Questionnaire (CRQ) in a face-to-face interview. Mastery represents one of the four CRQ domains containing 4 items. Patients rate their experience on each item a 7-point scale ranging from 1 (maximum impairment) to 7 (no impairment). The subscale "Mastery" is calculated by averaging the scores of the 4 items belonging to this subscale.

  From Baseline to Follow-Up (0, 8, 16, 28 weeks)

• Quality of Life (CRQ)

  Change from baseline in Quality of Life (at week 8) measured with the CRQ. The CRQ contains 20 items across four domains: dyspnea, fatigue, emotional function, and mastery. Quality of life is calculated by adding all responses to all 20 items. Patients rate their experience on each item a 7-point scale ranging from 1 (maximum impairment) to 7 (no impairment)

  From Baseline to Follow-Up (0, 8, 16, 28 weeks)

• Symptom Burden (IPOS)

  Change from baseline in palliative care needs and specific symptoms (at week 8) assessed with the Integrated Palliative Care Outcome Scale (IPOS). The IPOS includes 10 symptoms and 7 questions on patients and carers emotional situation, spiritual concerns, and provision of information and support. The overall profile score is the sum of the scores from each of the 17 questions.

  From Baseline to Follow-Up (0, 8, 16, 28 weeks)

• Carers' burden of disease (ZBI)

  Change from baseline in carers' burden (at week 8) assessed with the Zarit Burden Inventory (ZBI), measuring personal strain and role strain. The revised version contains 22 items. Each item is a statement which the carer is asked to endorse using a 5-point scale. Response options range from 0 (never) to 4 (nearly always).

  From Baseline to End of Intervention (0, 8, 16 weeks)

Secondary Outcomes (4)

• Breathlessness severity (NRS)

  From Baseline to Follow-Up (0, 8, 16, 28 weeks)

• Generic health-related quality of life (EQ-5D-5L)

  From Baseline to Follow-Up (0, 8, 16, 28 weeks)

• Costs of health service utilization in Euros

  From Baseline to Follow-Up (0, 8, 16, 28 weeks)

• Patient survival measured in days

  From randomization until death, up to end of study (24 months)

Study Arms (2)

Intervention Group

EXPERIMENTAL

Patients randomised to the intervention group will get immediate access to the Multi-professional breathlessness service (MBS).

Other: Multi-professional breathlessness service (MBS)

Control Group

OTHER

Patients randomised to the control group will get delayed MBS intervention. They will receive standard care and get access to the service after a waiting time of eight weeks.

Other: Delayed MBS Intervention

Interventions

Multi-professional breathlessness service (MBS) OTHER

Patients visit the MBS twice. At week 1, delivered by palliative care specialists and respiratory disease specialists, patients receive an detailed assessment of breathlessness, relevant symptoms beyond breathlessness, psychosocial issues and carer burden. Recommendations are provided, and reviewed at the concluding visit in week 6 with palliative care specialists. In between these visits, weekly physiotherapy sessions focus on positioning, breathing techniques, exercise as well as pacing and fatigue management. Further support from the multi-professional expert team is given as needed.

Intervention Group

Delayed MBS Intervention OTHER

Patients will wait 8 weeks for start of intervention and will receive standard care in the meantime with access to respiratory medicine, general practitioners and palliative care services as needed. Standard care includes support by their general practitioners and disease orientated treatment (e.g. anti-obstructive treatment, oxygen supply if indicated, chemotherapy).

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients affected by breathlessness due to any advanced life-limiting and progressive disease, despite treatment of the underlying condition and
• Patients capable (in a cognitive and functional manner) to participate in the intervention including outpatient clinic and physiotherapist visits as well as self- management
• If patients are suffering from acute exacerbations of the underlying conditions, they are put on a waiting list for two to four weeks and are then entered into the trial.

You may not qualify if:

• Patients suffering from breathlessness due to chronic hyperventilation syndrome, asthma or any other unknown cause
• Cancer patients under concurrent initial or full dose systemic treatment or radiotherapy (except on maintenance therapy)
• Patients participating in any trial targeting the treatment of underlying conditions/ illness

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead
• University Hospital Munich: collaborator
• Helmholtz Zentrum München: collaborator
• University of Cambridge: collaborator
• King's College London: collaborator

Study Sites (1)

Hospital of the University of Munich, Department of Palliative Medicine

Munich, Bavaria, 81377, Germany

Location

Related Publications (1)

• Schunk M, Le L, Syunyaeva Z, Haberland B, Tanzler S, Mansmann U, Schwarzkopf L, Seidl H, Streitwieser S, Hofmann M, Muller T, Weiss T, Morawietz P, Rehfuess EA, Huber RM, Berger U, Bausewein C. Effectiveness of a specialised breathlessness service for patients with advanced disease in Germany: a pragmatic fast-track randomised controlled trial (BreathEase). Eur Respir J. 2021 Aug 26;58(2):2002139. doi: 10.1183/13993003.02139-2020. Print 2021 Aug.

  PMID: 33509957 DERIVED

Related Links

• Study website
• MBS website

MeSH Terms

Conditions

Dyspnea; Pulmonary Disease, Chronic Obstructive; Neoplasms; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Study Officials

• Claudia Bausewein, Prof.Dr.med.

  Munich University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: October 31, 2015
• First Posted: December 4, 2015
• Study Start: March 2, 2015
• Primary Completion: February 1, 2019
• Study Completion: April 30, 2019
• Last Updated: August 9, 2019

Record last verified: 2019-08

Locations

DE (1)