Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

All Conditions

Rare Diseases

Dyspnea

Respiration Disorders

Respiratory Tract Diseases

Signs and Symptoms, Respiratory

Oculocerebral Syndrome With Hypopigmentation

Oxygen and air administration

Jennifer AM Philip, MBBS

The purpose of this study is to determine the effect that oxygen has when administered to patients complaining of shortness of breath, where the underlying cause of this symptom is advanced cancer. The study tests the hypothesis that oxygen improves shortness of breath more than air in this population. Both oxygen and air will be administered to patients in random order and in a blinded fashion, with patients asked to rate their shortness of breath before and after each gas. Finally patients will be asked which gas they prefer.

Dyspnoea is a devastating symptom in patients with advanced cancer. Management strategies are limited and include behavioural therapies such as relaxation, and pharmacological therapies such as opioids and anxiolytics. The latter are associated with problematic side effects in many patients. Inhalational oxygen is frequently administered but there are few studies in this population which define its role and benefits.

Main Aim: To compare patient preference for inhalational oxygen versus air for relief of dyspnoea.

Specific aims:

1. To compare the patient preference for inhalational oxygen versus compressed air in the relief of dyspnoea.
2. To compare the response to oxygen and air in improvement of dyspnoea in patients with advanced cancer.
3. To compare the response to oxygen and air in improvement of dyspnoea in those patients with advanced cancer with documented hypoxia.
4. To identify factors other than hypoxia which impact on the sensation of dyspnoea and its relief, when patients are administered oxygen and air.

Hypotheses

1. Oxygen improves dyspnoea in patients with cancer more than compressed air.
2. Patients with cancer who are hypoxic are more likely than those who are not hypoxic to have improvement of dyspnoea with oxygen administration.
3. The cause of the dyspnoea may affect whether dyspnoea improves more with oxygen than with air.

Using a randomised, double blind, crossover study design, patients will be adminstered air and oxygen for 15 minutes and be asked to rate dyspnoea scores before and after each gas. Measures of oxygen saturation will be simultaneously measured, and finally the patient preferences for the gases will be sought at trial completion.

The Role of Oxygen in the Management of Dyspnoea in Advanced Cancer

A Randomised, Double-Blind Cross-Over Trial of the Effect of Oxygen on Dyspnoea in Patients With Advanced Cancer

Peter MacCallum Cancer Centre, Australia

Bethlehem Griffiths Research Foundation

Australian and New Zealand Society of Palliative Medicine

Bayside Health

Heart and Blood Diseases

Neoplasms

Heart Failure

Lung Neoplasms

Chronic Graft Versus Host Disease

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The Role of Oxygen in the Management of Dyspnoea in Advanced Cancer	NCT00206609	Cancer	Oxygen and air ...	18 Years -	Bayside Health
Trial of a Breathlessness Intervention Service for Intractable Breathlessness	NCT00678405	Dyspnea	Breathlessness ... Best supportive...	18 Years -	Cambridge University Hospitals NHS Foundation Trust

Spots Global Cancer Trial Database for dyspnoea

Every month we try and update this database with for dyspnoea cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for dyspnoea

Every month we try and update this database with for dyspnoea cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for dyspnoea cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.