Shortness Of Breath in Lung Cancer | Not Recruiting
Shortness Of Breath in Lung Cancer | Not Recruiting
Shortness Of Breath in Lung Cancer
SOB-LC II

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Medical Conditions
  • Intrathoracic cancer
Primary Contact Details
Dr Miriam Johnson
See all trial contact details
Recruitment Status
Not Recruiting
Trial source and source ID number
ISRCTN49387307
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
http://cancerhelp.cancerresearchuk.org/trials/a-trial-comparing-2-training-programmes-manage-breathlessness-people-with-cancer-affecting-lungs-sob-lc2
Research Details
  • Three breathing training sessions at weekly intervals are more effective than a single session in reducing the breathlessness severity of patients with intra-thoracic malignancy and refractory breathlessness.

    Please note that this record is related to a previously registered trial entitled "Breathlessness training: comparison of two programmes for Shortness Of Breath in Lung Cancer" (ISRCTN62865905), and can be found at http://www.isrctn.com/ISRCTN62865905.
Phase
Sorry, this information is not available
Study Design
Multicentre randomised controlled non-blinded parallel-group study
Study Type
Interventional
Intervention

Patients randomised to the single session training arm will be taught the four techniques of management of breathlessness (breathing control, pacing, anxiety management and relaxation) at a single session in a clinical setting appropriate to the needs of the patient by the therapist.

Patients randomised to the three session training arm will be taught the same four techniques of the management of breathlessness at a single session in a clinical setting appropriate to the needs of the patient by the therapist. This will be followed by practice and reinforcement face-to-face with the therapist on two further occasions at weekly intervals.

Both groups will receive written reinforcement in the form of information booklets plus verbal reinforcement in the format of the patients choice (CD, video or DVD) will be given to remind the patient of the techniques they have been taught. One week after the final visit, the therapist will ring the patient to see if they have remembered to practise the techniques and if they have managed to watch/listen to the reinforcement information.

The primary analysis point is a 4 weeks, but participants will be followed up until 8 weeks.

Intervention Type
Behavioural
Primary Outcome Measures
    Worst severity of breathlessness over past 24 hours measured by NRS
Secondary Outcome Measures
    1. Breathlessness score on NRS (severity: average over last 24 hours)
    2. NRS distress from breathlessness
    3. NRS satisfaction with care of breathlessness
    4. Global impression of changes of breathlessness
    5. CRQ-SAS
    6. HADS
    7. Brief COPE/NRS cope
    8. EQ5D
    9. CIEQ-Chr
    10. Number of other interventions for breathlessness during study period
    11. Number of hospital admissions during study period
    12. Costs associated with both comparators
    13. Correlation with baseline BFI, MTQ, CIEQ-Chr scores
    14. Correlation with patient programme preference

    The following are measured at all time points: breathlessness severity (average over past 24 hours); distress due to, coping with, and satisfaction with the management of breathlessness; EQ5D. All secondary endpoints are measured at weeks 4 and 8 except for the global impression of change of breathlessness which is only measured at week 4.
Publication(s)
2014 cost-effectiveness results in: http://www.ncbi.nlm.nih.gov/pubmed/28142878
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26345362
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
Adult
Who Can Participate
Patient
Number of Participants
146
Participant Inclusion Criteria
    1. Primary or secondary malignant lung disease
    2. Aged over 18 years
    3. Willingness to engage with breathlessness training
    4. Ability to give informed consent
    5. Sufficient understanding of the English language to complete the study questionnaires
    6. Severity average breathlessness (Numeric Rating Scale [NRS]) greater than 3
    7. All identified reversible causes of the breathlessness have been treated if appropriate to do so, in the opinion of the attending clinician
    8. Verbal confirmation of consent
    9. Estimated prognosis (in the investigator's opinion) of greater than 3 months
Participant Exclusion Criteria
    1. Inability to give informed consent
    2. Intercurrent illness or co-morbidities making completion of the study unlikely
    3. Rapidly worsening breathlessness requiring urgent medical intervention
    4. Insufficient understanding of the English language to complete the study questionnaires
    5. Verbal withdrawal of consent
    6. Unable to complete study assessments
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Scarborough
YO12 5RE
Trial Contact(s)
Primary Trial Contact
Dr Miriam Johnson
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A randomised trial of high versus low intensity training in breathing techniques for breathlessness in patients with malignant lung disease: early intervention
EudraCT Number
Sorry, this information is not available
Funder(s)
  • National Institute for Health Research
Other Study ID Numbers
Version 2
Sponsor(s)
Hull and East Yorkshire Hospitals NHS Trust (HEYHT) (UK)
Key Dates

Recruitment Start Date

25 May 2011

Recruitment End Date

31 Mar 2013

Trial Start Date

01 Apr 2011

Trial End Date

31 Mar 2013

Date added to source

25 Jan 2011

Date updated in source

06 Feb 2017