Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000271404
Ethics application status
Approved
Date submitted
23/02/2016
Date registered
1/03/2016
Date last updated
7/11/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised comparison of how different terminologies for papillary thyroid cancer affect decision making about treatment among an Australian community sample
Scientific title
Randomised comparison of how different terminologies for papillary thyroid cancer affect decision making about treatment among an Australian community sample
Secondary ID [1] 288603 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thyroid cancer 297745 0
Condition category
Condition code
Public Health 297927 297927 0 0
Other public health
Cancer 297968 297968 0 0
Thyroid

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will test how different terminologies used to describe the same diagnosis (papillary thyroid cancer) affect decision making about treatment. This will be done by surveying a population from the Australian community with no history of thyroid cancer and presenting them with 3 hypothetical scenarios that describe a diagnosis of papillary thyroid cancer using various terminology with and without the "cancer" term. The terms presented to participants are papillary thyroid cancer, papillary lesions of indolent course and abnormal cells. Participants will also be given a table with information on the risks and benefits to each treatment option (total thyroidectomy, hemi-thyroidectomy or active surveillance) so that participants are able to make an informed decision about their treatment options. Each hypothetical scenario and the treatment options presented to participants will be identical with the only difference being the terminology used.

Participants will be called randomly using random-digit dialing to mobile numbers across Australia by an experienced independent social research company (the Hunter Research Foundation). Participants who agree to participate will be sent a link via email to the online survey. Participants will then complete the survey which includes all 3 hypothetical scenarios at once. It is estimated to take participants 10-15 minutes to complete.

The aim of this intervention is to assess if the term "cancer" used to describe a diagnosis of papillary thyroid cancer may impact patient treatment preferences (primary outcomes) as well as psycho-social outcomes (secondary outcomes).
Intervention code [1] 293996 0
Treatment: Other
Comparator / control treatment
The comparator will be the treatment preference choice. We will be comparing the proportion that choose each treatment option under the two descriptions (cancer term included - papillary thyroid cancer vs. no cancer term included - papillary lesions of indolent course or abnormal cells).
Control group
Active

Outcomes
Primary outcome [1] 297446 0
The primary outcome is treatment decision making. This will be measured for each scenario with different terminology presented by participants selecting between 3 treatment options (thyroidectomy, hemi-thyroidectomy, active surveillance).
Timepoint [1] 297446 0
Immediately following intervention (5-10 minutes after participants are presented with the hypothetical diagnosis scenario).
Secondary outcome [1] 321071 0
Diagnosis-related anxiety. Measured using a 1-item Visual Analog Scale.

Davey, HM, Barratt AL, Butow PN, Deeks JJ. A one-item question with a Likert or Visual Analog Scale adequately measured current anxiety. Journal of Clinical Epidemiology 2007;60:356-360.
Timepoint [1] 321071 0
Immediately following intervention (approximately 5 minutes after participants are presented with the hypothetical diagnosis scenario).
Secondary outcome [2] 321192 0
Treatment-related anxiety. Measured using a 1-item Visual Analog Scale.

Davey, HM, Barratt AL, Butow PN, Deeks JJ. A one-item question with a Likert or Visual Analog Scale adequately measured current anxiety. Journal of Clinical Epidemiology 2007;60:356-360.
Timepoint [2] 321192 0
Immediately following intervention (approximately 5 minutes after participants are presented with the hypothetical diagnosis scenario).
Secondary outcome [3] 321193 0
General anxiety. Measured using the State-Trait Anxiety Inventory,

Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Speilberg State-Trait Anxiety Inventory (STAI). British Journal of Clinical Psychology 1992;31:301-306.
Timepoint [3] 321193 0
Immediately following intervention (10-15 minutes after participants are presented with the hypothetical diagnosis scenario).
Secondary outcome [4] 321194 0
Cancer worry. Measured using a 4-point Likert scale.

Sutton S, Bickler G, Sancho-Alridge J, Saidi G. Prospective study of predictors of attendance for breast screening in inner London. Journal of Epidemiology and Community Health 1994;48(1):65-73.
Timepoint [4] 321194 0
Immediately following intervention (10-15 minutes after participants are presented with the hypothetical diagnosis scenario).
Secondary outcome [5] 321198 0
Health literacy. Measured by a 1-item health literacy screening question.

Morris NS, MacLean CD, Chew LD, Littenberg B. The single item literacy screener: evaluation of a brief instrument to identify limited reading ability. BMC Family Practice 2006;7:21.
Timepoint [5] 321198 0
Immediately following intervention (10-15 minutes after participants are presented with the hypothetical diagnosis scenario).
Secondary outcome [6] 321201 0
Personal/family history of cancer. Multiple choice question.
Timepoint [6] 321201 0
Immediately following intervention (10-15 minutes after participants are presented with the hypothetical diagnosis scenario).

Eligibility
Key inclusion criteria
Participants in this study will be men and women across the Australian community identified through random digit dialing. Participants will be eligible to participate in the study if they are above 18 years of age, are fluent in English and have no history of a thyroid cancer diagnosis. Researchers will try and recruit a 1:1 ratio of male and female participants.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded from the study if they are unable to speak adequate English upon initial contact, if they do not have a valid email address to access the survey, are below the age of 18 years and have been diagnosed with thyroid cancer.

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)
Central randomisation by phone. Once a participant agrees to take part in the study they will be randomly assigned to be immediately sent one of the versions of the survey.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computerised sequence generation will be used. An independent research organisation (the Hunter Research Foundation) will use their software to administer the randomisation.
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
Efficacy
Statistical methods / analysis
The sample size was calculated by simplifying the assumption that if a person does not opt for surgical treatment (active surveillance) when a more serious description is used (ie. papillary thyroid cancer) they will also not opt for surgical intervention when a less serious description is used (ie. abnormal cells) Since we are carrying out multiple comparisons (3 terms analysed separately using McNemar’s test, alpha=0.05/3=0.01667) we would need 264 participants to detect a 5% change. We also want to analyse men and women separately therefore, we would need 264 men and 264 women (aim to recruit 600 participants total).

Data will be analysed using chi-square tests to compare the treatment choices (primary outcome) between study arms. A univariate analysis of factors (secondary outcomes and demographic characteristics) associated with surgical treatment choice will be used. A multivariate logistic regression model will also be used to assess predictors of surgical treatment choice by terminology used, including diagnosis and treatment related anxiety, general anxiety, cancer worry, health literacy and personal/family history of cancer.

.All data will be analysed by researchers at the University of Sydney and compiled for publication and dissemination.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2016
Actual
28/04/2016
Date of last participant enrolment
Anticipated
1/06/2016
Actual
5/07/2016
Date of last data collection
Anticipated
Actual
5/07/2016
Sample size
Target
600
Accrual to date
Final
550
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 292947 0
Government body
Name [1] 292947 0
National Health and Medical Research Council (NHMRC) Program Grant 633003
Country [1] 292947 0
Australia
Primary sponsor type
University
Name
Sydney School of Public Health
Address
University of Sydney
NSW
2006
Country
Australia
Secondary sponsor category [1] 291719 0
None
Name [1] 291719 0
Address [1] 291719 0
Country [1] 291719 0
Other collaborator category [1] 278850 0
Individual
Name [1] 278850 0
A/Prof Juan P Brito
Address [1] 278850 0
Endocrinology & Metabolism, Mayo Clinic
200 1st Street SW
Rochester, MN
55905
Country [1] 278850 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294454 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 294454 0
Ethics committee country [1] 294454 0
Australia
Date submitted for ethics approval [1] 294454 0
29/10/2015
Approval date [1] 294454 0
08/12/2015
Ethics approval number [1] 294454 0
2015/916

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

Contacts
Principal investigator
Name 63794 0
Prof Kirsten McCaffery
Address 63794 0
307F Edward Ford Building (A27)
University of Sydney
NSW 2006
Country 63794 0
Australia
Phone 63794 0
+61 2 9351 7220
Fax 63794 0
Email 63794 0
[email protected]
Contact person for public queries
Name 63795 0
Kirsten McCaffery
Address 63795 0
307F Edward Ford Building (A27)
University of Sydney
NSW 2006
Country 63795 0
Australia
Phone 63795 0
+61 2 9351 7220
Fax 63795 0
Email 63795 0
[email protected]
Contact person for scientific queries
Name 63796 0
Kirsten McCaffery
Address 63796 0
307F Edward Ford Building (A27)
University of Sydney
NSW 2006
Country 63796 0
Australia
Phone 63796 0
+61 2 9351 7220
Fax 63796 0
Email 63796 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
SourceTitleYear of PublicationDOI
EmbaseEffect of a Change in Papillary Thyroid Cancer Terminology on Anxiety Levels and Treatment Preferences: A Randomized Crossover Trial.2018https://dx.doi.org/10.1001/jamaoto.2018.1272
N.B. These documents automatically identified may not have been verified by the study sponsor.