Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000925842
Ethics application status
Approved
Date submitted
29/08/2012
Date registered
30/08/2012
Date last updated
9/06/2021
Date data sharing statement initially provided
9/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing strategies to improve breathlessness and related symptoms in people with lung cancer
Scientific title
A pilot study of a multicomponent non-pharmacological intervention to reduce breathlessness and associated symptoms in people with lung cancer
Secondary ID [1] 281123 0
Nil
Universal Trial Number (UTN)
U1111-1133-9671
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung cancer 287290 0
Condition category
Condition code
Cancer 287617 287617 0 0
Lung - Non small cell
Cancer 287622 287622 0 0
Lung - Mesothelioma
Cancer 287623 287623 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention combines breathing re-training with individualised psychosocial support, delivered using evidence based psycho-educational strategies to improve breathlessness and additional intervention components which focus on reducing the impact of co-occurring symptoms on dyspnoea (cough, pain, fatigue, anorexia) in the form of a face-to-face instructional session of about 60 minutes delivered by experienced registered nurses, followed by weekly phone calls for 3 weeks. The instruction is supplemented by a range of resources to reinforce intervention delivery and promote self-management, including audio recordings, printed fact sheets, an individualised management plan, as well as communication and referral to a relevant health provider in the community (GP, Practice Nurse or Community/Domiciliary Nurse).
Intervention code [1] 285577 0
Other interventions
Comparator / control treatment
Patients allocated to the control group will similarly receive a face-to-face instructional session on breathlessness management comprising of breathing retraining and psychosocial support of about 60 minutes delivered by experienced nurses, followed by weekly phone calls for 3 weeks.
Control group
Active

Outcomes
Primary outcome [1] 287869 0
The primary outcome of this pilot study is to the feasibility of a multicomponent non-pharmacological intervention in improving cancer patients' ability to manage breathlessness and the related cluster of symptoms associated with breathlessness. Assessment of feasibility includes recruitment issues, likely attrition rates and acceptability of interventions (measured by dropout rates due to the nature of intervention during the study), which are essential for consideration in planning a larger clinical trial. It will also help determine the effect size for sample size estimation to adequately power a future larger clinical trial.
Timepoint [1] 287869 0
T1 (at recruitment), T2 (4 weeks post intervention), T3 (8 weeks post intervention).
Primary outcome [2] 287870 0
Performance status assessed by the Australia-modified Karnofsky Performance Scale;
Timepoint [2] 287870 0
T1 (at recruitment), T2 (4 weeks post intervention), T3 (8 weeks post intervention).
Secondary outcome [1] 298964 0
Breathlessness severity, distress and impact - 5 items 11 point Numeric Rating Scale
Timepoint [1] 298964 0
T1 (at recruitment), T2 (4 weeks post intervention), T3 (8 weeks post intervention).
Secondary outcome [2] 298965 0
Anxiety and depression assessed using the 14-item 4-point Hospital Anxiety and Depression Scale;
Timepoint [2] 298965 0
T1 (at recruitment), T2 (4 weeks post intervention), T3 (8 weeks post intervention).
Secondary outcome [3] 298966 0
Severity of co-occurring symptoms (cough, pain, fatigue, anorexia) assessed by the 7-item 11-point (0-10) Symptom Assessment Scale;
Timepoint [3] 298966 0
T1 (at recruitment), T2 (4 weeks post intervention), T3 (8 weeks post intervention).
Secondary outcome [4] 298967 0
Use of non-pharmacological methods for managing breathlessness and co-occurring symptoms at 4 and 8 weeks; the scale includes two sub-scales: the first including items assessing use of strategies for improving breathing efficiency and effectiveness, and the second assessing use of psychosocial support strategies. For each item, patients report whether or not they have used the specific strategy in the past week and, if used, to rate on a four point scale from 'not at all' to 'very much' how useful the strategy was in reducing their breathlessness.
Timepoint [4] 298967 0
T1 (at recruitment), T2 (4 weeks post intervention), T3 (8 weeks post intervention).

Eligibility
Key inclusion criteria
Diagnosed with a primary or secondary lung cancer; life expectancy of at least 3 months; completed first line therapy;
have an average dyspnoea rating > 2 on an 11 point numeric rating scale in the past week
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
< 18 years; have an intellectual or mental impairment; primary language other than English

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)
Potentially eligible patients will be first approached by Clinical staff and asked if they would like to participate in the study. If patients agree, the research nurses will then approach the patients and provide them with an information sheet explaining the study. Patients will be asked for permission to obtain relevant clinical and demographic information from their records for use only in this study. Consent for access to this information is also included in the Information Sheets and Consent Forms. Patients will be allowed as much time as necessary to consider their involvement in the study, and if they agree to participate, written consent will be obtained. Participants will have the opportunity to ask questions before completing the consent form.

Using a computer generated table of random sequence, all recruited patients will be allocated randomly within each study site to one of two conditions (intervention/control). After informed consent is obtained, 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 by SPSS
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
1/12/2012
Actual
18/02/2013
Date of last participant enrolment
Anticipated
Actual
18/08/2014
Date of last data collection
Anticipated
Actual
17/10/2014
Sample size
Target
30
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 19700 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 34331 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 285899 0
University
Name [1] 285899 0
Queensland University of Technology
Country [1] 285899 0
Australia
Funding source category [2] 308804 0
Charities/Societies/Foundations
Name [2] 308804 0
Cancer Australia
Country [2] 308804 0
Australia
Funding source category [3] 308805 0
Other Collaborative groups
Name [3] 308805 0
PC4
Country [3] 308805 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
School of Nursing, Queensland University of Technology, Victoria Park Rd, Kelvin Grove, QLD 4059
Country
Australia
Secondary sponsor category [1] 284723 0
Hospital
Name [1] 284723 0
Princess Alexandra Hospital
Address [1] 284723 0
199 Ipswich Rd, Woolloongabba, QLD 4102
Country [1] 284723 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287928 0
Princess Alexandra Hospital
Ethics committee address [1] 287928 0
Ethics committee country [1] 287928 0
Australia
Date submitted for ethics approval [1] 287928 0
13/09/2012
Approval date [1] 287928 0
19/12/2012
Ethics approval number [1] 287928 0
HREC/12/QPAH/603
Ethics committee name [2] 308722 0
Queensland University of Technology Human Research Ethics Committee
Ethics committee address [2] 308722 0
Ethics committee country [2] 308722 0
Australia
Date submitted for ethics approval [2] 308722 0
13/08/2012
Approval date [2] 308722 0
03/10/2012
Ethics approval number [2] 308722 0
1300000035

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

Contacts
Principal investigator
Name 34638 0
Prof Patsy Yates
Address 34638 0
Queensland University of Technology, 88 Musk Ave, Kelvin Grove, QLD 4059
Country 34638 0
Australia
Phone 34638 0
+61 7 3138 2132
Fax 34638 0
Email 34638 0
[email protected]
Contact person for public queries
Name 17885 0
Patsy Yates
Address 17885 0
School of Nursing, Queensland University of Technology Victoria Park Road Kelvin Grove QLD 4059
Country 17885 0
Australia
Phone 17885 0
+ 61 7 3138 3835
Fax 17885 0
Email 17885 0
[email protected]
Contact person for scientific queries
Name 8813 0
Patsy Yates
Address 8813 0
School of Nursing, Queensland University of Technology Victoria Park Road Kelvin Grove QLD 4059
Country 8813 0
Australia
Phone 8813 0
+ 61 7 3138 3835
Fax 8813 0
Email 8813 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.