Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000556741
Ethics application status
Approved
Date submitted
30/03/2022
Date registered
11/04/2022
Date last updated
11/04/2022
Date data sharing statement initially provided
11/04/2022
Date results information initially provided
11/04/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of different unconditional monetary incentives on survey response rates in men with prostate cancer: a 2-arm SWAT
Scientific title
Impact of different unconditional monetary incentives on survey response rates in men with prostate cancer: a 2-arm SWAT
Secondary ID [1] 306807 0
NA
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12620000170921
http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379100&isReview=true

This SWAT (study within a trial) was a sub-study to the parent trial/study listed above.

Health condition
Health condition(s) or problem(s) studied:
prostate cancer 325877 0
Condition category
Condition code
Cancer 323190 323190 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We conducted a randomised study within a trial (SWAT) in a case-control cross-sectional study aiming to explore the social-ecological reasons why prostate cancer patients discontinued active surveillance. All participants were recruited through the South Australian Prostate Cancer Clinical Outcomes Collaborative (SA-PCCOC). Participants in the main study were to complete a survey that took approximately 20-30 minutes to complete. Prior to the mail-out, a pilot test (N=32 controls) was conducted to assess the probable response rate. Six of the 32 responded (19% response rate). Therefore, alterations to the materials and protocol were made in an attempt to boost the response rate. We reduced the survey length (by two pages, reducing time to complete to ~ 20 minutes), sent all participants a priming letter two weeks prior to study materials, and included an unconditional incentive.

Participants were randomised to receive either an AUD$10 or AUD$20 unconditional gift card (redeemable at thousands of Australian stores) incentive with the study materials. In this SWAT, we aimed to investigate if (a) response rate would vary by different relatively large unconditional incentive amounts, and (b) patient characteristics (e.g., age, marital status, employment status, education level) would vary in those who responded within the different incentive groups.

Intervention group: Recieved a $20 unconditional monetary incentive with their study materials.
Intervention code [1] 323267 0
Behaviour
Comparator / control treatment
The control/comparator group received the same study materials as the intervention group, but instead received a $10 unconditional monetary incentive.
Control group
Active

Outcomes
Primary outcome [1] 330945 0
The primary outcome of the SWAT was the proportion of responders. Responders were defined as those who either (a) completed and returned a survey (i.e., participants) or (b) did not complete and return the survey but did complete and return a form that had been included with the survey on which individuals could indicate their ineligibility for the study due to having never been on active surveillance (“Never on Active Surveillance” form). Packages returned to sender and returned blank questionnaires were not counted as responses.
Timepoint [1] 330945 0
at 1 month after mail-out of study materials.
Secondary outcome [1] 408188 0
The secondary outcome of the SWAT was differences in demographic variables in responders within each incentive group. This self-reported information was sourced from the completed surveys (marital status, employment status, and education level) and the registry (postcode, diagnosis information, and age).
Timepoint [1] 408188 0
In analysis (response cut off 1 month after study material mail-out).

Eligibility
Key inclusion criteria
As in the main trial, participants must have met the following eligibility criteria:

Age 18+ years old, had been diagnosed with prostate cancer between January 2014 and October 2019, were able to communicate in English, and had been on active surveillance for at least six months immediately following their prostate cancer diagnosis.
Minimum age
18 Years
Maximum age
80 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
NA

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Matched groups from the case-control study were randomized 1:1 between the two study arms using block randomisation with random block lengths of two or four. Of the eligible participants, 121 were provided the AUD$10 incentive and 117 received the AUD$20 incentive.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Descriptive statistics to illustrate participant demographics were performed. Mixed-effects logistic regression with matched groups as the random effect was used to compare differences in response rates between the two incentive groups. To compare differences in demographics by incentive group responders, Pearson’s chi-square analyses (for categorical variables) and Welsh’s two-sample T tests (for continuous variables) were used. The significance level was set at 0.05 (two-sided). All analyses were completed in R

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Planned recruitment of participants from other Australian state registries did not go ahead due to COVID-19 shutdowns.
Date of first participant enrolment
Anticipated
Actual
3/02/2020
Date of last participant enrolment
Anticipated
Actual
28/02/2020
Date of last data collection
Anticipated
Actual
31/03/2020
Sample size
Target
450
Accrual to date
Final
238
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 311143 0
Charities/Societies/Foundations
Name [1] 311143 0
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Country [1] 311143 0
Australia
Primary sponsor type
Individual
Name
Megan McIntosh
Address
University of Adelaide,
North Terrace, South Australia, 5000
Country
Australia
Secondary sponsor category [1] 312490 0
None
Name [1] 312490 0
Address [1] 312490 0
Country [1] 312490 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310670 0
The Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 310670 0
Office for Research
Flinders Medical Centre
Ward 6C, Room 6A219
Flinders Drive, Bedford Park, SA, 5042
Ethics committee country [1] 310670 0
Australia
Date submitted for ethics approval [1] 310670 0
Approval date [1] 310670 0
04/06/2019
Ethics approval number [1] 310670 0
HREC/19/SAC/88

Summary
Brief summary
The main study aimed to explore men's reasons for transitioning from active surveillance to further treatment in prostate cancer management, and the factors which may have contributed to this decision. In this study within a trial, we investigated whether response rates to the questionnaire would differ by incentive amount (provided as an unconditional monetary incentive in the form of a gift card). All participants were required to complete a one-time survey (sent via mail but may be completed on paper, online, or via telephone). This survey consists of questions relating to social-ecological factors (i.e., personal, social, community, organisation, policy) and your experience with active surveillance. Participants in the main study were randomised to receive either a $20AUD or $10AUD unconditional incentive with their study materials. We aimed to investigate whether (a) response rates to a 30-minute questionnaire completed via mail, online, or phone would vary with different unconditional incentive amounts, and (b) demographics would vary in those who responded within the different incentive groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118462 0
Ms Megan McIntosh
Address 118462 0
University of Adelaide,
North Terrace Campus,
South Australia, 5000
Country 118462 0
Australia
Phone 118462 0
+61447870173
Fax 118462 0
Email 118462 0
megan.mcintosh@adelaide.edu.au
Contact person for public queries
Name 118463 0
Ms Megan McIntosh
Address 118463 0
University of Adelaide,
North Terrace Campus,
South Australia, 5000
Country 118463 0
Australia
Phone 118463 0
+61447870173
Fax 118463 0
Email 118463 0
megan.mcintosh@adelaide.edu.au
Contact person for scientific queries
Name 118464 0
Ms Megan McIntosh
Address 118464 0
University of Adelaide,
North Terrace Campus,
South Australia, 5000
Country 118464 0
Australia
Phone 118464 0
+61447870173
Fax 118464 0
Email 118464 0
megan.mcintosh@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified individual participant data collected from the study will be shared.
When will data be available (start and end dates)?
As soon as possible following publication. There is no current end-date.
Available to whom?
Researchers who provide a methodologically sound proposal
Available for what types of analyses?
To achieve the aims in the approved proposal
How or where can data be obtained?
Data will be published unrestricted on Figshare (https://figshare.com/).


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.