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Trial registered on ANZCTR


Registration number
ACTRN12618001306202
Ethics application status
Approved
Date submitted
1/08/2018
Date registered
2/08/2018
Date last updated
31/05/2019
Date data sharing statement initially provided
31/05/2019
Date results information initially provided
31/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Intentions for Cancer Screening in Older Adults
Scientific title
The Effect of Different Communication Strategies about Stopping Cancer Screening on Intention to Screen and Cancer Anxiety: a Randomised Online Study in Older Adults
Secondary ID [1] 294948 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The effect of communication strategies about cancer screening cessation 307945 0
Condition category
Condition code
Mental Health 306976 306976 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 306977 306977 0 0
Health promotion/education
Cancer 306978 306978 0 0
Breast
Cancer 306979 306979 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be delivered online and will take approximately 20-30 minutes to complete.

Time 1 intervention: Hypothetical scenarios will be used to communicate the benefits and harms of cancer screening and to test different communication strategies on outcome measures. The text scenarios will be presented online using Qualtrics survey software.

Intervention materials: A hypothetical scenario of a doctor’s visit- Participants will be asked to imagine that their doctor is speaking to them about cancer screening, providing them with the benefits and harms and telling them of the importance of making an informed decision.

Participants will be randomised to receive one of four hypothetical scenarios, where the final statement the GP makes will be varied:
1) Benefits vs. harms: "This test may harm you more than benefit you."
2) Benefits vs. harms + negative framing life expectancy: "You may not live long enough to benefit from breast screening/PSA testing, and this test may harm you more than benefit you."
3) Benefits vs. harms + positive framing life expectancy: "Breast screening/PSA testing may not help you to live longer, and this test may harm you more than benefit you."
4) Benefits vs. harms + health status: "This test may harm you more than benefit you, so other aspects of your health should take priority."

Time 2 Intervention: Second hypothetical scenario will highlight the counterintuitive nature of stopping screening.
After completing the outcome measures after viewing the first hypothetical scenario, all participants will be presented with another scenario. They will be asked to imagine their GP continues discussing with them the idea of stopping screening. The GP will acknowledge the counterintuitive nature of stopping screening by providing an anchoring frame, where a reason for why the change in recommendation has occurred.

The second hypothetical scenario will read:
"For many years breast/prostate cancer screening has been strongly recommended, but we now know more about the harms and benefits than we did when these cancer screening programs began.
A large body of research has shown that for older people like you the harms might outweigh the benefits such as those that we discussed earlier.
So, this is why I don't think you should get the test anymore."


Intervention code [1] 301271 0
Behaviour
Comparator / control treatment
The control group will be provided the same explanation and summary of associated benefits and risks of breast/prostate screening in the hypothetical scenario of a doctor's visit, but will not receive an additional statement after "This test may harm you more than benefit you".
Control group
Active

Outcomes
Primary outcome [1] 305963 0
Intention to have a PSA test/breast screening: a single item on a 10-point scale assessing hypothetical intention to get screening/testing, adapted from previous research (Copp et al., 2017) (1=Definitely will not to 10=Definitely will).
Timepoint [1] 305963 0
Immediately after participants have read their first respective hypothetical scenarios of the doctors visit at Time 1, and again after the second hypothetical scenario at Time 2.
Primary outcome [2] 305965 0
Cancer anxiety (level of anxiety about developing breast/prostate cancer) will be measured using two items with ten responses ranging from not worried at all to extremely worried, guided by Scherer et al., 2018.
Timepoint [2] 305965 0
After participants have read their first respective hypothetical scenarios of the doctors visit at Time 1 and been asked about intention to screen, and again after the second hypothetical scenario at Time 2.
Secondary outcome [1] 347123 0
Trust in the information provided by GP in the scenarios will be measured by a single item using a 5-point scale (very little trust, to a great deal of trust), guided by Hillen et al., 2014.
Timepoint [1] 347123 0
After participants have read their first respective hypothetical scenarios of the doctors visit at Time 1
Secondary outcome [2] 347124 0
Trust in GP will be measured by a single item using a 5-point scale (very little trust, to a great deal of trust), guided by Hillen et al., 2014.
Timepoint [2] 347124 0
After participants have read their first respective hypothetical scenarios of the doctors visit at Time 1
Secondary outcome [3] 347125 0
Trust in the Australian health system will be measured using a single item with a 5-point scale (very little trust, to a great deal of trust) guided by Hillen et al., 2014.
Timepoint [3] 347125 0
After participants have read their first respective hypothetical scenarios of the doctors visit at Time 1
Secondary outcome [4] 347126 0
Decisional conflict will be measured using a ten-item measure with a 3-point scale (yes, no, unsure), (O’Connor, 1995).
Timepoint [4] 347126 0
After participants have read their first respective hypothetical scenarios of the doctors visit at Time 1
Secondary outcome [5] 347127 0
Knowledge/understanding of the information presented in scenario one will be measured using a single item with responses true, false and don’t know, guided by Hersch et al., 2015.
Timepoint [5] 347127 0
After participants have read their first respective hypothetical scenarios of the doctors visit at Time 1
Secondary outcome [6] 347128 0
Knowledge/understanding of the information presented in scenario two will be measured using a single item with responses true, false and don’t know.
Timepoint [6] 347128 0
Measured after participants are presented with the second hypothetical scenario at Time 2 and have answered questions regarding intention and cancer anxiety.

Eligibility
Key inclusion criteria
Australian older adults aged 65 years or older who have had a PSA test or mammogram at least once in the past 10 years
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Previous diagnosis of prostate cancer, breast cancer or dementia

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)
Participants will be sent an email link to access the Qualtrics survey by the recruitment company Research Now. The link will direct participants to read the online consent form. After giving consent participants will be randomised to one of the four hypothetical scenarios using Qualtrics survey software. The researcher will be unaware of which condition participants are randomised to, as randomisation occurred after participants had clicked on the link to complete the online intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using Qualtrics survey software, stratified by gender.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
A sample size calculation using Cohen’s d formula indicates that a sample size of N = 252 would be ample to detect a moderate effect size (f = .25) with 80% power and alpha at 0.025. This means each group will have a minimum of 63 participants.

We will use a one-way Analysis of Variance (ANOVA) using SPSS Version 22.0 to test differences in outcomes between the three experimental conditions. Additionally, repeated measures using within-subjects ANOVA will determine whether there is a change in intention and cancer anxiety after the second scenario is presented.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 299532 0
Government body
Name [1] 299532 0
National Health and Medical Research Council Program
Address [1] 299532 0
Level 1, 16 Marcus Clarke Street, Canberra City ACT 2600
Country [1] 299532 0
Australia
Primary sponsor type
University
Name
School of Public Health, University of Sydney
Address
Edward Ford Building (A27)
The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 298893 0
None
Name [1] 298893 0
Address [1] 298893 0
Country [1] 298893 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300431 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 300431 0
Human Ethics Office
Margaret Telfer Building (K07)
University of Sydney
NSW 2006
Ethics committee country [1] 300431 0
Australia
Date submitted for ethics approval [1] 300431 0
11/05/2018
Approval date [1] 300431 0
16/05/2018
Ethics approval number [1] 300431 0
2018/357

Summary
Brief summary
Cancer screening is one aspect of health care that is perceived as “more equals better”. However, there is uncertainty associated with the benefits and harms of screening for cancer in older adults. More specifically, evidence shows that older men and women are more likely to experience net harm from breast and prostate cancer screening than younger adults. However, it is challenging to communicate effectively and sensitively about these issues to older adults. Qualitative research suggests that life expectancy could be helpful to mention, but the way that it is framed could have importance in how the information is received. The aim of this study is to examine different strategies to communicate with older people about the option of stopping cancer screening, taking into account well-known heuristics and biases that impact on decision making in this group. In particular, we will test the effect of different strategies to communicate about benefits versus harms and life expectancy. Furthermore, we will compare positively and negatively framed statements of life expectancy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83642 0
Dr Jesse Jansen
Address 83642 0
126a Edward Ford Building (A27)
The University of Sydney
NSW 2006
Country 83642 0
Australia
Phone 83642 0
+61 02 9351 5178
Fax 83642 0
Email 83642 0
jesse.jansen@sydney.edu.au
Contact person for public queries
Name 83643 0
Dr Jesse Jansen
Address 83643 0
126a Edward Ford Building (A27)
The University of Sydney
NSW 2006
Country 83643 0
Australia
Phone 83643 0
+61 02 9351 5178
Fax 83643 0
Email 83643 0
jesse.jansen@sydney.edu.au
Contact person for scientific queries
Name 83644 0
Dr Jesse Jansen
Address 83644 0
126a Edward Ford Building (A27)
The University of Sydney
NSW 2006
Country 83644 0
Australia
Phone 83644 0
+61 02 9351 5178
Fax 83644 0
Email 83644 0
jesse.jansen@sydney.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 individual participant data collected during the trial can be made available in de-identified csv or excel datasets, along with the data dictionary.
When will data be available (start and end dates)?
Data will be made available once the manuscript outlining results from the study has been published for up to 5 years after publication.
Available to whom?
Data will be made available upon request to anyone wishing to access it who provides a methodologically sound proposal to the principal investigator.
Available for what types of analyses?
Replication and meta-analysis.
How or where can data be obtained?
Data will be made available upon direct contact with the principal investigator. Contact details of the principal investigator are: jesse.jansen@sydney.edu.au
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary