Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000087459
Ethics application status
Approved
Date submitted
24/01/2007
Date registered
25/01/2007
Date last updated
25/11/2019
Date data sharing statement initially provided
25/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Non-pharmacological interventions for dyspnoea in lung cancer patients
Scientific title
Evaluating the effectiveness of a patient education program which includes breathing exercises and psychosocial support for helping patients with lung cancer to control their dyspnoea.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung cancer patients 1580 0
Condition category
Condition code
Cancer 1683 1683 0 0
Lung - Non small cell
Public Health 1684 1684 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The enhanced non-pharmacological intervention group (ENPT) experience a 60 minute educational session on management of dyspnoea run by a registered nurse. Patients are then followed up with weekly phone calls for 3 weeks. The instruction is supplemented with a range of resources to reinforce intervention delivery and promote self managment.
Intervention code [1] 1571 0
Other interventions
Comparator / control treatment
The standard education group (control group) receive one clinic visit lasting approximately 60 minutes where they will be provided with instructions on principles for managing dyspnoea. There will be no follow up phone calls or additional supplementary resources given to them.
Control group
Active

Outcomes
Primary outcome [1] 2327 0
Use of non-pharmacological interventions.
Timepoint [1] 2327 0
T1 (baseline), T2 (4 weeks), T3 (8 weeks).
Primary outcome [2] 2328 0
Numeric rating scale to measure dyspnoea and Cancer Dyspnoea Scale.
Timepoint [2] 2328 0
T1(baseline), T2 (4weeks), T3 (8 weeks), T3 (12 weeks), then every 4 weeks until they are too unwell, death or completion of the study (3 years).
Primary outcome [3] 2329 0
Functional Assessment of Cancer Therapy - Lung (FACT-lung) quality of life instrument (version 3).
Timepoint [3] 2329 0
T1(baseline), T2 (4 weeks), T3 (8weeks).
Primary outcome [4] 2330 0
Dyspnoea Interference Scale.
Timepoint [4] 2330 0
T1 (baseline), T2(4 weeks), T3 (8 weeks), T3 (12 weeks) then every 4 weeks until they are too unwell, death or completion of the study (3 years).
Primary outcome [5] 2331 0
Eastern Cooperative Oncology Group (ECOG) performance rating scale.
Timepoint [5] 2331 0
T1 (baseline), T2 (4 weeks), T3 (8 weeks), T3 (12 weeks) then every 4 weeks until they are too unwell, death or completion of the study (3 years).
Primary outcome [6] 2332 0
Hospital Anxiety and Depression Scale.
Timepoint [6] 2332 0
T1(baseline), T2, (4 weeks), T3 (8weeks), T3 (12 weeks) and then every 4 weeks until they are too unwell, death or completion
of the study (3 years).
Primary outcome [7] 2333 0
Memorial Symptom Assessment Scale.
Timepoint [7] 2333 0
T1(baseline), T2 (4 weeks), T3 (8 weeks).
Secondary outcome [1] 4069 0
Clinical status
Timepoint [1] 4069 0
(T1(baseline)m T2 (4 weeks) T3 (8 weeks)

Eligibility
Key inclusion criteria
Diagnosis: Patients diagnosed with small cell or non-small cell lung cancer; have completed first line therapy for their disease; have an average dyspnoea rating of >2 on 11 point numeric rating scale in the past week; have an aniticipated life expectancy of at least 3 months.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:Demonstrated cognitive impairment that would prevent them from responding to a survey questionniare; have a life expectancy of less than 3 mths.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Using a computer generated table of random numbers, all recruited patients will be allocated randomly within each site to one of two conditions. Research staff at the hospital site identify eligible patients through consultation with clinicians and administer baseline (T1)questionnaires. After completion of baseline questionnaires, a central project manager randomly allocates the patient to intervention or control groups. Staff involved in baseline and follow up assessments are different to those delivering the interventions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation by using a computer generated table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The research staff involved in pre and post intervetion assessments will not be informed of participant allocation
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2007
Actual
13/03/2008
Date of last participant enrolment
Anticipated
Actual
13/01/2011
Date of last data collection
Anticipated
Actual
7/07/2011
Sample size
Target
214
Accrual to date
Final
144
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 1828 0
Government body
Name [1] 1828 0
National Health and Medical Research Council
Country [1] 1828 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Country
Australia
Secondary sponsor category [1] 1647 0
Hospital
Name [1] 1647 0
Mater Health Services, Queensland
Address [1] 1647 0
Raymond Terrace, South Brisbane Qld 4101
Country [1] 1647 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3420 0
Mater Adult Hospital, Brisbane, Queensland
Ethics committee address [1] 3420 0
Ethics committee country [1] 3420 0
Australia
Date submitted for ethics approval [1] 3420 0
Approval date [1] 3420 0
17/05/2007
Ethics approval number [1] 3420 0
Ethics committee name [2] 3421 0
The Prince Charles Hospital
Ethics committee address [2] 3421 0
Ethics committee country [2] 3421 0
Australia
Date submitted for ethics approval [2] 3421 0
Approval date [2] 3421 0
03/05/2007
Ethics approval number [2] 3421 0
Ethics committee name [3] 3422 0
Royal Brisbane and Womens Hospital
Ethics committee address [3] 3422 0
Ethics committee country [3] 3422 0
Australia
Date submitted for ethics approval [3] 3422 0
Approval date [3] 3422 0
03/06/2009
Ethics approval number [3] 3422 0
Ethics committee name [4] 3423 0
Queensland University of Technology
Ethics committee address [4] 3423 0
Ethics committee country [4] 3423 0
Australia
Date submitted for ethics approval [4] 3423 0
Approval date [4] 3423 0
30/05/2007
Ethics approval number [4] 3423 0
Ethics committee name [5] 304809 0
Princess Alexandra Hospital Human Research Ethics Committee
Ethics committee address [5] 304809 0
Ethics committee country [5] 304809 0
Australia
Date submitted for ethics approval [5] 304809 0
21/04/2008
Approval date [5] 304809 0
17/06/2008
Ethics approval number [5] 304809 0
2008/068

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27505 0
Prof Patsy Yates
Address 27505 0
School of Nursing, N Block, Queensland University of Technology, Kelvin Grove, QLD 4059
Country 27505 0
Australia
Phone 27505 0
+61 7 3138 2132
Fax 27505 0
Email 27505 0
[email protected]
Contact person for public queries
Name 10760 0
Patsy Yates
Address 10760 0
Queensland University of Technology
Victoria Park Road
Kelvin Grove QLD 4059
Country 10760 0
Australia
Phone 10760 0
+61 7 31386116
Fax 10760 0
Email 10760 0
[email protected]
Contact person for scientific queries
Name 1688 0
Patsy Yates
Address 1688 0
Queensland University of Technology
Victoria Park Road
Kelvin Grove QLD 4059
Country 1688 0
Australia
Phone 1688 0
+61 7 31386116
Fax 1688 0
Email 1688 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.