Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000215527
Ethics application status
Approved
Date submitted
24/05/2006
Date registered
31/05/2006
Date last updated
31/05/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving continuity of clinical care and educating general practitioners – development and evaluation of information sheets about chemotherapy for general practitioners
Scientific title
Improving continuity of clinical care and educating general practitioners – development and evaluation of information sheets about chemotherapy in patients with cancer for general practitioners
Universal Trial Number (UTN)
Trial acronym
GP Fax Sheets
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer (general) 1193 0
Condition category
Condition code
Cancer 1278 1278 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves standardised faxed information (letter and drug information sheets) being sent to the GP of patients receiving chemotherapy at Peter Maccallum Cancer Centre. The faxed sheet will be one page long and sent immediately after the establishment of a baseline (a questionnaire testing GPs knowledge of their patients chemotherapy regime related side-effects administered directly after a patient begins their chemotherapy regime).
Intervention code [1] 1069 0
Other interventions
Comparator / control treatment
The contol gorup will receive usual correspondance from Peter Maccallum, which consists of a non-standardised letter written by the patient's Medical Oncologist.
Control group
Active

Outcomes
Primary outcome [1] 1727 0
The primary outcome of the evaluation will be improved GP knowledge regarding management of patients having chemotherapy
Timepoint [1] 1727 0
Measured one week after the administration of the intervention.
Primary outcome [2] 1728 0
The primary outcome of the evaluation will be improved self-perceived confidence regarding management of patients having chemotherapy
Timepoint [2] 1728 0
Measured one week after the administration of the intervention.
Secondary outcome [1] 3082 0
For GPs – providing improved care for their patients on the basis of the consistent and comprehensive information provided.
Timepoint [1] 3082 0
Secondary outcome [2] 3083 0
For patients – enhanced care through more integrated health care delivery between Peter Mac and GPs and better-informed GPs. This might result in fewer uncontrolled side effects, and greater access to medical staff able to manage their side effects.
Timepoint [2] 3083 0
Secondary outcome [3] 3084 0
For Peter Mac – improved relationship with the GP community, fewer unplanned admissions due to inadequately controlled side effects, potentially fewer admissions of seriously unwell patients; more rapid triage of patients with life-threatening side effects such as febrile neutropenia. These outcomes will be measured at follow up one week after the administration of the intervemtion.
Timepoint [3] 3084 0

Eligibility
Key inclusion criteria
To be eligible GPs must:1.Be the nominated GP of a patient with a defined cancer type, who is scheduled to commence a defined chemotherapy regimen 2.Agree to be randomised to either the intervention group who will receive faxed or e-mailed information or to the usual contact group3.Agree to participate in two brief telephone surveys (‘pre’ and ‘post’)4.Provide verbal informed consent to participate in this study
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
To be eligible GPs must not:1.have already been enrolled in this study (if the same GP is treating two patients who are receiving chemotherapy in the Day Ward at Peter MacCallum Cancer Centre only the 1st patient will be included in this study)2. have a patient is is receiving concurrent radiotherapy.All age ranges and both genders will be included within the study.

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)
Sealed Opaque Envelope Procedure
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Biased Coin Procedure
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1400 0
Commercial sector/Industry
Name [1] 1400 0
Roche Products
Country [1] 1400 0
Primary sponsor type
Charities/Societies/Foundations
Name
Peter Macallum Cancer Centre
Address
Country
Australia
Secondary sponsor category [1] 1230 0
Commercial sector/Industry
Name [1] 1230 0
Roche Products
Address [1] 1230 0
Country [1] 1230 0
Switzerland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2752 0
Peter Maccallum Cancer Centre
Ethics committee address [1] 2752 0
Ethics committee country [1] 2752 0
Australia
Date submitted for ethics approval [1] 2752 0
Approval date [1] 2752 0
Ethics approval number [1] 2752 0
05/33

Summary
Brief summary
The primary objective of this project is to demonstrate that the provision of information about chemotherapy and management of chemotherapy side effects
1.is perceived by GPs to be useful and,
2.when compared to usual care, results in
(a)improved knowledge;
(b)enhanced confidence regarding the management of patients having chemotherapy and
(c)higher satisfaction with shared care with Peter Mac
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36216 0
Address 36216 0
Country 36216 0
Phone 36216 0
Fax 36216 0
Email 36216 0
Contact person for public queries
Name 10258 0
Carl Baravelli
Address 10258 0
Educational Centre - Level 3, St Andrews Place East Melbourne Vic
Postal Address: Locked Bag 1 A'Beckett Street Victoria 8006
Country 10258 0
Australia
Phone 10258 0
+61 3 9656 1667
Fax 10258 0
+61 3 9656 1337
Email 10258 0
Carl.Baravelli@Petermac.org
Contact person for scientific queries
Name 1186 0
Carl Baravelli
Address 1186 0
Educational Centre - Level 3 St Andrews Place East Melbourne VIC
Locked Bag 1 A'Beckett Street VIC 8006
Country 1186 0
Australia
Phone 1186 0
+61 3 9656 1667
Fax 1186 0
+61 3 9656 1337
Email 1186 0
Carl.Baravelli@Petermac.org

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
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