Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000193279
Ethics application status
Approved
Date submitted
9/04/2009
Date registered
20/04/2009
Date last updated
1/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Academic detailing -an educational program for General Practioners (GPs) to aid in their management of cancer patients with breathlessness.
Scientific title
A randomised pilot study to develop and explore the efficacy of an academic detailing educational program for General Practioners (GPs) targeting dyspnoea symptom management in palliative cancer patients.
Secondary ID [1] 284416 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Academic detailing for cancer patients with breathlessness.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dyspnoea in cancer patients at end of life. 4580 0
Condition category
Condition code
Respiratory 4876 4876 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Academic detailing (an educational program) based upon the best available evidence, given to GPs by an experienced Respiratory and Palliative Care physician.The academic detailing is delivered face to face at a place and time suitable to the GP (usually at his/her surgery). There are 2 sessions, the first 2 weeks then 4 weeks after randomisation. The sessions last approximately 15-30 minutes.
The patient is not present at these sessions but is visited at home 3 times by the study nurse, at baseline, week 6 and week 8. These visits last about 30 minutes and are at a time convenient to the patient. The information collected is about their general health, breathlessness and the medications they take.
The detailing pertains specifically to their patient enrolled in the study but the topics cover 4 key messages. They are
treatment of the underlying conditions contributing to their patients dyspnoea, which is assessed and amended if necessary. Examples of this may include management of pleural effusions, obstructions and anaemia.
Pharmacological treatments: -Drug therapies can be varied but include oxygen and opioids.
Non-pharmacological:- Complementary and alternative medical treatments such as visualisation, breathing training, time and pacing training can be included in some nurse led clinics or complementary therapy programmes.
Pulmonary rehabilitation:- Referral to established programmes are appropriate in some circumstances and can overcome the barrier of GP time, while improving patient function.
Duration of the intervention is approximately 8 weeks for the patient and 10 weeks for the GP.
Intervention code [1] 4336 0
Other interventions
Comparator / control treatment
Same care and teaching that is normally offered to GPs through SAPS(Southern Palliative Care Services). SAPS medical specialists offer advice to GPs by telephone during the day and after hours. They can also refer patients to palliative care outpatients and request patients to be reviewed at home by medical specialists and/or community palliative care nurses.
Control group
Active

Outcomes
Primary outcome [1] 5720 0
The primary outcome is the uptake of key messages by GPs. This will be assessed by a single questionnaire which will ask questions about the current treatments GPs use for their patients with dyspnoea, acceptability of the academic detailing program and how it has impacted on their practice.
Timepoint [1] 5720 0
Approximately 10 weeks after randomisation.
Secondary outcome [1] 241649 0
Patient sensation of dyspnoea measured by the 0-10 point numerical rating scale (NRS) for dyspnoea and a categorical or verbal rating scales for dyspnoea.
Timepoint [1] 241649 0
At baseline,and at 6 weeks and 8 weeks post randomisation.
Secondary outcome [2] 241650 0
Patient level of function measured by the modified MRC (Medical Research Council Scale)and the DES
(Dyspnoea Exertion Scale)
Timepoint [2] 241650 0
At baseline and at 6 weeks and 8 weeks post randomisation.
Secondary outcome [3] 241651 0
Patient quality of life measured by the McGill QOL Questionnaire.
Timepoint [3] 241651 0
At baseline and at 6 weeks and 8 weeks post randomisation.
Secondary outcome [4] 241652 0
Patient self-efficacy measured by the Australian-modified Karnofsky Performance Scale and a global rating scale.
Timepoint [4] 241652 0
At baseline and at 6 weeks and 8 weeks post randomisation.
Secondary outcome [5] 241653 0
Stress and anxiety of patients measured by the Edmonton Symptom Assessment.
Timepoint [5] 241653 0
At baseline, and at 6 weeks and 8 weeks post randomisation

Eligibility
Key inclusion criteria
Moderate to severe dyspnoea (score of 3-5 on the modified MRC scale.)
Referred to Southern Palliative Services (SAPS) with cancer.
Within the geographic area visited by SAPS Community Palliative Care Nurses.
All GPs of patients who consent to the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are cognitively impaired Mini Mental Status Examination (MMSE) <24 .
Patients who are dying at time of referral (expected death within 2 weeks)
Patients who are referred to SAPS while hospital in-patients and are unlikely to be discharged( no further GP involvement). Patients who do not give consent or whose GP does not give consent.

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)
Allocation involved contacting the holder of the allocation scheldule who was at central administration.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by computerised sequence generation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
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
13/03/2007
Date of last participant enrolment
Anticipated
15/09/2008
Actual
15/09/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4768 0
Charities/Societies/Foundations
Name [1] 4768 0
The Cancer Council of South Australia
Country [1] 4768 0
Australia
Primary sponsor type
University
Name
Flinders University - Department of Palliative and Supportive Services
Address
700 Goodwood Road
Daw Park
SA 5041
Country
Australia
Secondary sponsor category [1] 4305 0
None
Name [1] 4305 0
Address [1] 4305 0
Country [1] 4305 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6816 0
Repatriation General Hospital Research and Ethics Committee
Ethics committee address [1] 6816 0
Ethics committee country [1] 6816 0
Australia
Date submitted for ethics approval [1] 6816 0
Approval date [1] 6816 0
15/11/2006
Ethics approval number [1] 6816 0
40/06

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

Contacts
Principal investigator
Name 29472 0
Prof David Currow
Address 29472 0
Department of Palliative and Supportive Services Flinders University 700 Goodwood Road Daw Park SA 5041
Country 29472 0
Australia
Phone 29472 0
61 8 8275 1871
Fax 29472 0
+61 8 8275 1201
Email 29472 0
[email protected]
Contact person for public queries
Name 12719 0
Professor David Currow
Address 12719 0
Department of Palliative and Supportive Services Flinerds University
700 Goodwood Road
Daw Park SA 5041
Country 12719 0
Australia
Phone 12719 0
+61 8 8275 1871
Fax 12719 0
+61 8 8275 1201
Email 12719 0
[email protected]
Contact person for scientific queries
Name 3647 0
Professor David Currow
Address 3647 0
Department of Palliative and Supportive Services, Flinders University
700 Goodwood Road
Daw Park SA 5041
Country 3647 0
Australia
Phone 3647 0
+61 8 8275 1871
Fax 3647 0
+61 8 8275 1201
Email 3647 0
[email protected]

No information has been provided regarding IPD availability


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.