Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Heart and Blood Diseases

Rare Diseases

Respiratory Insufficiency

Dyspnea

Lung Diseases

Pulmonary Disease, Chronic Obstructive

Heart Failure

Lung Diseases, Interstitial

Respiratory Tract Diseases

Respiration Disorders

Signs and Symptoms, Respiratory

Chronic Disease

Disease Attributes

Lung Diseases, Obstructive

Chronic Graft Versus Host Disease

Non-pharmacological strategies for the Management of episodic breathlessness

The cognitive and behavioral brief intervention comprises two parts: In a first module, the intervention and the study team is introduced, the definition of episodic breathlessness is given and the individual characteristics of breathlessness episodes are recorded. Goals of the intervention are discussed. In a subsequent module on patient education and the strategies, the patient and intervention executor discuss the patients' assumptions about episodic breathlessness including triggers and already used management strategies for breathlessness episodes. This follows the presentation of the non-pharmacological strategies: movement of air/ handheld fan, forward lean, diaphragmatic breathing, distraction, pursed lips breathing, long breaths out and relaxation training. The patient selects 2-3 strategies and trains them with the intervention executor.

Cognitive and Behavioral intervention for the Management of Episodic Breathlessness

Steffen Simon, Prof., M.Sc.

Episodic breathlessness is a common and distressing symptom in patients with advanced disease such as cancer, chronic obstructive pulmonary disease (COPD) and chronic heart failure. Since the short duration of the majority of breathless episodes limits the effectiveness of pharmacological interventions (e.g. opioids), non-pharmacological management strategies play a major role. As non-pharmacological strategies patients use, for example, cognitive and behavioural methods such as breathing or relaxation techniques.

The aim of the study is to test a brief cognitive and behavioural intervention for an improved management of episodic breathlessness. Initially, a Delphi procedure with international experts has been used to develop the brief intervention consisting of various non-pharmacological strategies to enhance the management of breathless episodes.

In the single-arm therapeutic exploratory trial (phase II), the feasibility and potential effects of the brief intervention, such as patient-reported breathlessness mastery, episodic breathlessness characteristics, quality of life, symptom burden, caregivers' burden, and breathlessness in general will be examined. The results of the study form the basis for planning and implementing a subsequent confirmatory randomized control trial (phase III).

Cognitive and Behavioral Intervention for the Management of Episodic Breathlessness in Patients With Advanced Disease

Cognitive and Behavioral Intervention for the Management of Episodic Breathlessness in Patients With Advanced Disease: a Single-arm Therapeutic Exploratory Trial (Phase II)

Ratio of patients screened and patients that signed informed consent

Ratio of patients who signed the informed consent and filled out the final assessment

Withdrawal from the study at specific date (e.g. Intervention, refresher, Outcome at week 2/4/6)

Hospital Anxiety and Depression Scale: the Depression Subscale (the higher the score, the worse the outcome)

Hospital Anxiety and Depression Scale: the Anxiety Subscale (the higher the score, the worse the outcome)

Mastery Domain of the Chronic Respiratory Questionnaire (the higher the score, the better the outcome)

Chronic Respiratory Questionnaire (the higher the score, the better the outcome)

Integrated Palliative Care Outcome Scale (the higher the score, the worse the outcome)

Dyspnea catastrophizing scale (the higher the score, the worse the outcome)

Zarid Burden Interview (the higher the score, the worse the Outcome)

University Hospital of Cologne

Bethanien Krankenhaus gGmbH

University of Cologne

Prfessor Dr Steffen Simon MSc

Neoplasms

Skin and Connective Tissue Diseases

Lung Neoplasms

Neoplasm Metastasis

Breast Neoplasms

Breast Diseases

Skin Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Acupuncture

The purpose of this study is to determine whether acupuncture is effective in relieving shortness of breath among breast and lung cancer patients.

Acupuncture for Shortness of Breath in Cancer Patients

National Cancer Institute (NCI)

National Center for Complementary and Integrative Health (NCCIH)

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).

Breathlessness Intervention Service

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.

Best supportive care (Standard Care)

Sara Booth, FRCP

Morag C Farquhar, PhD

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:

1. Is BIS more effective than standard care for patients with intractable breathlessness from advanced malignant or non-malignant disease?
2. Does it reduce patient and carer distress due to breathlessness, and increase patients' sense of mastery of the symptom?
3. What are the experiences and views of those who use BIS, their informal carers and the clinicians who refer to it?
4. Does BIS offer value for money for the NHS?

Research questions:

1. Is BIS more effective than standard care for patients with intractable breathlessness from advanced malignant or non-malignant disease?
2. Does it reduce patient \& carer distress due to breathlessness, \& increase patients' sense of mastery of the symptom?
3. What are the experiences \& views of those who use BIS, their informal carers \& the clinicians who refer to it?
4. Is BIS cost-effective?

To assess changes in patient outcomes attributable to BIS, a pragmatic RCT design will be conducted using a fast-track design (design proved highly acceptable at Phase II). Analysis will focus on comparing patients who have used BIS to those who have not (yet) used BIS (the use of BIS by the control group will occur subsequent to these measurement points).

The researcher will be blinded to the allocation of respondents up until discharge/referral on from BIS for FT patients or at the end of the waiting period for CC patients. This will be achieved by the researcher conducting study recruitment \& collecting baseline measures before instructing a third party (local clinical trials' nurse) to conduct randomisation \& reporting of allocation (to the patient \& BIS) using a random sequence of opaque envelopes previously generated by a statistician independent of BIS. Subsequently, all data will be handled using study identity numbers; group allocation identifiers will only be added at analysis. This model was used successfully in the Phase II pilot trial.

Data collected from the control group once they are in receipt of BIS (after their period on the waiting list when their group allocation was blinded to the researcher) will be treated as before/after data \& not RCT data. This will allow the collection of qualitative data from this group at the midpoint of using BIS.

The two broad disease courses, malignant (m) \& non-malignant (nm), will be considered separately due to their different trajectories \& needs, \& resultant different service models. The intervention model for patients with non-malignant disease consists of two-three visits \& three telephone contacts (to patient \&/or primary care staff) over a four-week period with a 16 week (from first assessment) follow up, whereas the model for patients with malignant disease consists of one visit in conjunction with a primary care professional/key worker \& two telephone contacts (to patient \&/or primary care staff/key worker) over a two-week period, with a six week (from first assessment) follow up . Thus, the measurement points for the disease groups will differ.

Data (quantitative/qualitative) will be collected for all respondents at baseline (t1), prior to randomisation. For those with non-malignant conditions (nm), this will be repeated for the FT group (nmFT) midway through the intervention (two weeks post commencing BIS; nmFTt2 - quantitative data only) \& at the equivalent time point for the CC group (i.e. two weeks from entering the waiting list; nmCCt2 - quantitative data only), then again after discharge/referral on from BIS for the fast track group (four weeks post commencing BIS; nmFTt3) \& four weeks after discharge (nmFTt5). As well as being interviewed at t1 (randomisation) \& t2 (midway between randomisation \& BIS - quantitative data only), the CC group (nmCC) will also be interviewed just prior to commencing BIS (nmCCt3), during BIS (two weeks post commencing BIS; nmCCt4) \& then again after discharge/referral on from BIS (four weeks post commencing BIS (nmCCt5). This will allow identification of whether or not respondents in the control group deteriorated significantly whilst waiting for BIS \& the impact of this on final outcomes. This model was successfully piloted at Phase II.

For those with malignant conditions (m), baseline measures (t1) will be repeated for the FT group (mFT) after discharge/referral on from BIS (two weeks post commencement of BIS; mFTt3) \& two weeks after discharge (mFTt5). For the CC group (mCC) baseline measures (t1) will be repeated just prior to commencing BIS (mCCt3) \& then again after discharge/referral on from BIS (two weeks post commencing BIS; mCCt5). Thus, due to the shorter time frame of the malignant service model, there would be no t2 or t4 measurement points.

Sample size is based on the existing literature \& on our experiences at Phase II. The estimated standard deviation of the primary outcome measure is 2.5. In order to detect a 2-point difference in mean outcome between groups (equivalent to 0.8sd effect size) with 80% power using a t-test at the 5% level of significance, it will be necessary to recruit 26 patients per arm per disease group (trial) followed up to provide an outcome, which will now be at an earlier time point to minimize attrition. By adjusting for the baseline of the primary outcome measure in the analysis using analysis of covariance we anticipate an improvement in the precision of the estimated intervention effect. We also anticipate an improvement from the use in the trial of the NRS measure rather than the more highly variable VAS version from the pilot used in this sample size calculation. Therefore we propose to recruit 120 patients, 60 per disease group to ensure adequate power, effect size and allowance for attrition.

Analysis will be on an intention to treat basis. Primary analysis will be by analysis of covariance of the NRS at the final time-point with adjustment for baseline NRS in order to improve precision of the estimated BIS versus comparison effect. Secondary analysis will more sensitively incorporate all time-points in a repeated measures linear regression to be able to detect any differences between BIS \& comparison emerging/changing over time within the initial period. All analysis will be documented prior to final data collection in an analysis plan, will be addressed with two-tailed tests \& be assessed at the 5% level of significance. Effects within \& between arms will be summarized using means \& 95% confidence intervals. If randomised effects are similar in malignant \& non-malignant groups, a combined effect will be estimated allowing a narrower overall confidence interval. Analysis will be conducted using SPSS software.

The cost of BIS for each patient will be calculated from service activity data combined with staff salary costs, plus on-costs, overheads \& equipment. Information on the use of other health \& social services \& informal care (proxy-valued as a homecare worker) will be collected with the Client Service Receipt Inventory. This will be combined with appropriate unit cost data (Curtis \& Netten, 2006) to generate service costs. Cost comparisons will be made using bootstrapping methods to account for any skewness in data distribution. Cost-effectiveness will be assessed by combining cost data with that on outcomes including quality-adjusted life years (QALYS), in the form of incremental cost-effectiveness ratio \& acceptability curves. Qualitative data will be analysed using a framework approach (Ritchie \& Spencer, 1993) conducted using NVivo software.

Trial of a Breathlessness Intervention Service for Intractable Breathlessness

Phase III Randomized Controlled Trial of a Breathlessness Intervention Service for Intractable Breathlessness.

University of Cambridge

King's College London

Cambridge University Hospitals NHS Foundation Trust

Dr Sara Booth

Individual, face-to-face 7-session self-management intervention delivered by a specialist oncology nurse/clinical case manager as a home-based approach using a manual for each session.

Patients in this condition will receive usual care as decided by their oncology clinic team or physician.

Individual, face-to-face 7-session self-management intervention delivered by a specialist oncology nurse/clinical case manager as a home-based approach using a manual for each session. The intervention is delivered through scheduled home visits (7 sessions about one-hour in length), telephone coaching (2 sessions/week to reinforce use of strategies and for symptom monitoring: 15 minutes), and nurse moderated online peer chat or chat that is self-initiated at other times (7 weekly sessions about one hour in length).

Self-management Intervention

Doris Howell, RN PhD

The purpose of this study is to investigate the suitability and practicality of a coaching and support intervention in helping patients to use daily strategies for managing breathlessness. Also, the investigators will try to understand how useful it is in helping patients to reduce intensity of breathlessness and its impact their quality of life.

Lung cancer is common worldwide and is a leading cause of death. Breathlessness (dyspnea or shortness of breath) is a highly prevalent clinical problem in lung cancer, developing early in 25-50% of patients due to advanced stage at presentation. It persists in 60% of survivors' post-lung resection and worsens with progressive disease with rates as high as 90% reported in the final months of life. Breathlessness is associated with a high degree of unpleasantness, negatively impacts on daily functioning, and multiple domains of quality of life, triggers fear and anxiety in patients and their family, and contributes to symptom specific and psychological distress. It is also costly to the health system as it contributes to urgent care use and hospitalization. The purpose of this pilot trial is to evaluate feasibility and acceptability of a self-management intervention for breathlessness in lung cancer.

Self-Management Intervention for Breathlessness in Lung Cancer

A Pilot Trial of a Self-Management Intervention for Breathlessness in Lung Cancer

Measured by Numeric Rating Scale for breathlessness intensity.

Measured by Distress of Breathlessness Numerical Rating Scale.

Measured by (a) Chronic Respiratory Questionnaire, (b) Medical Research Council Dyspnea Scale, and (c) BORG scale prior to, during, and at the end of the 6-Minute-Walk Test.

Measured by (a) individual self-report items for "self-efficacy for managing shortness of breath" and "self-efficacy for exercise" from the toolkit of Stanford measures; (b) Chronic Respiratory Questionnaire - Mastery subscale; (c) adapted COPD Self-Efficacy Scale developed for this study.

Measured by Symptom Representation Questionnaire.

Measured using (1) Daily activity log of physical activity;(2)Seven-Day Physical Activity Recall tool (7-day PAR);(3) Cognitive Symptom Management Scale;(4) Daily tracking log of self-management strategies

Measured by the Hospital Anxiety and Depression Scale.

Measured by (a) Functional Assessment of Cancer Therapy - Lung (FACT-L); and, (b)Chronic Respiratory Questionnaire.

Measured by three questions derived from the Stanford Self-Management Program Toolkit of Measures, regarding number of hospital days, emergency room visits, and visits to physicians related to their breathlessness.

Canadian Institutes of Health Research (CIHR)

University Health Network, Toronto

Behaviors and Mental Disorders

Quality of Life

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

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.

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.

Multi-professional breathlessness service (MBS)

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).

Delayed MBS Intervention

Claudia Bausewein, Prof.Dr.med.

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.

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

Randomised Controlled Trial Testing the Effectiveness of a New Multi-professional Breathlessness sErvice for Patients With Any Advanced diSease Against Usual Care (BreathEase)

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.

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)

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.

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).

Change from baseline in breathlessness severity (at week 8) measured with numerical rating scales (NRS). The NRS will be used to assess breathlessness over the last 24 hours on average,at rest and on exercise. Responses on a rating scale range from 1 (no breathlessness) to 10 (strongest imaginable breathlessness).

Change from baseline in patients' generic health-related quality of life measured with the EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L). The EQ-5D-5L essentially consists of 2 pages - the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The visual analogue scale of the EQ-5D-5L questionnaire ranges from 0 to 100 (with 0 representing the worst health the patient can imagine and 100 representing the best health the patient can imagine). Value sets of the EuroQol Group by time trade-off (TTO) will be used for scoring algorithm.

The EQ-5D-5L is a standardized instrument applicable to a wide range of health conditions for use as a measure of health and is especially suited to cost effectiveness analyses.

Mean costs of intervention and control group (excluding study related costs) will be estimated. To calculate sum of costs in Euros per group to receive one aggregated outcome, firstly the following resource use data will be collected: Outpatient care, Medication, Medical aids, Inpatient care, Nursing home/hospice, Rehabilitation, Remedies (physiotherapy, massage, other), Formal care, Home help, Informal care, Work absenteeism, and early retirement. Secondly, resource use categories will be monetarily valued using unit cost and multiplied with the collected amount of resource use. Thirdly, mean costs in Euros per group will be calculated.

Survival is defined as time from randomization to death irrespective of the cause of death. Participants who will not die during study course will be censored at the time of last contact which is planned for week 28 after last patient in. Survival status will be assessed by phone for all participants.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cognitive and Behavioral Intervention for the Management of Episodic Breathlessness in Patients With Advanced Disease	NCT04630743	Dyspnea Respiratory Ins... Neoplasms Pulmonary Disea... Lung Diseases Heart Failure Lung Diseases, ... Palliative Care Palliative Medi... Breathlessness	Cognitive and B...	18 Years -	University of Cologne
Acupuncture for Shortness of Breath in Cancer Patients	NCT00067691	Lung Neoplasms Breast Neoplasm...	Acupuncture	18 Years -	National Center for Complementary and Integrative Health (NCCIH)
Trial of a Breathlessness Intervention Service for Intractable Breathlessness	NCT00678405	Dyspnea	Breathlessness ... Best supportive...	18 Years -	Cambridge University Hospitals NHS Foundation Trust
Self-Management Intervention for Breathlessness in Lung Cancer	NCT01585883	Lung Cancer Breathlessness	Self-management...	18 Years -	University Health Network, Toronto
Cognitive and Behavioral Intervention for the Management of Episodic Breathlessness in Patients With Advanced Disease	NCT04630743	Dyspnea Respiratory Ins... Neoplasms Pulmonary Disea... Lung Diseases Heart Failure Lung Diseases, ... Palliative Care Palliative Medi... Breathlessness	Cognitive and B...	18 Years -	University of Cologne
Evaluation of a Multi-professional Breathlessness Service for Patients With Breathlessness Due to Any Advanced Disease	NCT02622412	Breathlessness COPD Cancer Chronic Heart F... Interstitial Lu...	Multi-professio... Delayed MBS Int...	18 Years -	Ludwig-Maximilians - University of Munich

Spots Global Cancer Trial Database for breathlessness