Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000892910
Ethics application status
Approved
Date submitted
20/08/2011
Date registered
22/08/2011
Date last updated
3/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A strategy to increase rates of patients recruited from an Australian Cancer Registry: A study involving survivors of haematological malignancies
Scientific title
In a registry based sample of adult haematological cancer survivors, what is the effect of an enhanced invitation letter on participation rates with participation rates of haematological cancer survivors who receive the standard registry letter?
Secondary ID [1] 262881 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Participation rates of haematological cancer survivors recruited from an Australian state-based Cancer Registry invited to take part in an unmet needs survey. 270610 0
Condition category
Condition code
Public Health 270777 270777 0 0
Other public health
Public Health 270787 270787 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention strategy is a modified version of the standard invitation and reminder letters sent from the Cancer Registry. The intervention letters are modified by incorporating specific changes to wording and formatting which have been identified as potentially increasing suitability, readability and legibility of written communication. Patients receiving the modified letters will make up the experimental arm of the study. Both the enhanced letter (intervention strategy) and the standard letter (control) were sent to participants via mail. Mailing of the invitation letters was carried out over several days. If participants had not responded to the invitation letter approximately 4 weeks after they were mailed a reminder letter (an enhanced reminder for the intervention group and the standard reminder letter for the control group) was sent to non-responders via mail. Again mailing of the reminder letters occurred over several days.
Intervention code [1] 269236 0
Behaviour
Comparator / control treatment
Participants in the control arm will receive the standard invitation and reminder letters sent from the Cancer Registry
Control group
Active

Outcomes
Primary outcome [1] 279471 0
Participant/study consent rates as assessed by survivors returning a completed survey.
Timepoint [1] 279471 0
At the completion of the study.
Secondary outcome [1] 287707 0
Nil
Timepoint [1] 287707 0
Nil

Eligibility
Key inclusion criteria
Participants were survivors identified by the Cancer Registry as:
* Having been diagnosed between 1 July 2007 and 30 June 2010
* Diagnosed with a blood cancer (including leukaemias, lymphomas and myelomas)
* Aged between 18 and 80 years.
* Alive.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Survivors were ineligible to participate if they were:
* Deceased;
* Had previously indicated to the Cancer Registry that they did not wish to be contacted about participating in research studies;
* Were uncontactable.

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)
800 survivors diagnosed with a blood cancer between 1st July 2007 and 30th June 2010 and aged between 18 and 80 were chosen from the Cancer Registry. Staff from the Cancer Registry randomly allocated 400 survivors to the intervention group and 400 survivors to the control group through random number allocation. Random number was generated by an external .exe file, while sorting and implementation of cutoff was done in excel. The researchers were not involved in the random allocation of survivors, so were blinded to this process until data was collected.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number was generated by an external .exe file, while sorting and implementation of cutoff was done in excel.
Masking / blinding
Blinded (masking 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
20/09/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269703 0
Government body
Name [1] 269703 0
beyondblue and Cancer Australia
Country [1] 269703 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 268742 0
None
Name [1] 268742 0
Address [1] 268742 0
Country [1] 268742 0
Other collaborator category [1] 252219 0
Government body
Name [1] 252219 0
Western Australian Cancer Registry
Address [1] 252219 0
Western Australian Cancer Registry
Dept of Health (WA)
1st floor C Block, 189 Royal St
EAST PERTH WA 6004
Country [1] 252219 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271665 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 271665 0
Research Services
Research Office
The University of Newcastle
Callaghan NSW 2308
Ethics committee country [1] 271665 0
Australia
Date submitted for ethics approval [1] 271665 0
Approval date [1] 271665 0
17/06/2010
Ethics approval number [1] 271665 0
H-2009-0032
Ethics committee name [2] 271666 0
Department of Health WA Human Research Ethics Committee
Ethics committee address [2] 271666 0
DOHWA HREC
1st Floor 'C' Block
189 Royal Street
East Perth WA 6004
Ethics committee country [2] 271666 0
Australia
Date submitted for ethics approval [2] 271666 0
Approval date [2] 271666 0
11/08/2010
Ethics approval number [2] 271666 0
1/11/2009

Summary
Brief summary
We have conducted a RCT sub-study within the recruitment phase of a larger project utilising an Australian Cancer Registry to recruit survivors of a haematological study. This sub-study aimed to test the effect of two different patient invitation and reminder letters on participation rates to the study from patients. The first invitation and reminder letters were the standard letters sent by the Cancer Registry. Patients receiving this letter acted as the control arm of the intervention. The second invitation and reminder letters were modified versions of the standard letters incorporating specific changes to wording and formatting which have been identified as potentially increasing suitability, readability and legibility.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33049 0
Address 33049 0
Country 33049 0
Phone 33049 0
Fax 33049 0
Email 33049 0
Contact person for public queries
Name 16296 0
Laureate Professor Rob Sanson-Fisher
Address 16296 0
University of Newcastle
David Maddison Building
University Drive
Callaghan NSW 2308
Country 16296 0
Australia
Phone 16296 0
+61 2 49138169
Fax 16296 0
Email 16296 0
[email protected]
Contact person for scientific queries
Name 7224 0
Laureate Professor Rob Sanson-Fisher
Address 7224 0
University of Newcastle
David Maddison Building
University Drive
Callaghan NSW 2308
Country 7224 0
Australia
Phone 7224 0
+61 2 49138169
Fax 7224 0
Email 7224 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.