Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617000066381
Ethics application status
Approved
Date submitted
11/01/2017
Date registered
13/01/2017
Date last updated
1/11/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Treatment decision making in papillary thyroid cancer: an online discrete choice experiment survey
Scientific title
Treatment decision making in papillary thyroid cancer: an online discrete choice experiment survey
Secondary ID [1] 290891 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Papillary thyroid cancer 301605 0
Condition category
Condition code
Cancer 301314 301314 0 0
Thyroid

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention aims to test the factors (trade-offs of risks including surgical side-effects, cancer progression and risk of mortality) that are most important to patients when deciding between treatment options (total surgery, partial surgery or active surveillance, which will be described as monitoring to participants) for papillary thyroid cancer, and whether this differs based on the terminology used to describe the condition. This understanding will enable further discussion and understanding as to how the varying terms to describe the same diagnosis change patient decision making and how powerful and influential the term ‘cancer’ can be. It will also provide insight into the acceptability of active surveillance as a management option for papillary thyroid cancer.

Participants in this study will be men and women across the Australian community identified and recruited using a market research company specialising in online panel survey research (Survey Sampling International, SSI). This company maintains an extensive database of over 100,000 Australians, who have indicated their willingness to be involved in online survey research. To be eligible participants need to be above the age of 18, be fluent in English and have no previous history of a thyroid cancer diagnosis. Potential participants will be recruited to reflect the general population in terms of sex, age, cultural background, education, employment status, income. Participants will be excluded from the study if they are below the age of 18, unable to speak adequate English and have been diagnosed with thyroid cancer.

The intended sample size for recruitment will be between 750-1000 participants in each arm (in total between 1500-2000 participants). Piloting the survey will produce results to allow for more a more definite sample size to be determined. Previous experience with discrete choice experiments (DCE), and the use of an efficient DCE design that will be generated using specific software to minimize sample size requirements, will ensure that this sample is sufficient to accurately and robustly estimate model parameters and subsequent benefit harm trade-offs.

This quantitative survey study is intended to take approximately 3-5 months for recruitment and completion of the survey by participants. The study will be conducted via an online survey, accessed through SSI. Each survey will taking approximately 10-15 minutes for participants to complete.

Data will be collected directly from participants in the form of an online survey. Once invited by email by SSI, participants will be provided a link to login in to the discrete choice survey. Participants will be provided with an online Participant Information Sheet. As this is an online survey, no signed consent will be sought, rather, if respondents proceed beyond the Participant Information Sheet and consent information and complete and submit the survey, this will be considered evidence of consent (as discussed in NHMRC National Statement on Ethical Conduct in Human Research (2007)). Participants will be randomised to either receive the cancer term (papillary thyroid cancer) or non-cancer term (papillary lesions). The discrete choice survey will consist of at least 6 choice questions comparing different decision making scenarios. Participants will be asked to choose the option they most prefer for each question. This will be presented as a two part question to give people an option not to choose either scenario. Following completion of the discrete choice questions, participants will be asked some additional sociodemographic questions such as age, education level, employment status and personal and family history of cancer.

By observing participant choices for different scenarios using DCE, the analyst is able to construct sets of utility functions. These utility functions model the weights that individuals attach to each of the attributes, and as such, allow for an estimation of the relative importance of each attribute.
Intervention code [1] 296835 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 vs no cancer term) and based on the varying attributes given to participants (chance of requiring lifelong medication, follow-up required, chance of recurrence etc.).
Control group
Active

Outcomes
Primary outcome [1] 300723 0
The primary outcome is treatment decision making. This will be measured for each scenario with different terminology and attributes presented by participants selecting between 3 treatment options (thyroidectomy, hemi-thyroidectomy, active surveillance).
Timepoint [1] 300723 0
Immediately following intervention (5-10 minutes after participants are presented with the hypothetical diagnosis scenario).
Secondary outcome [1] 330701 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 [1] 330701 0
Immediately following intervention (10-15 minutes after participants are presented with the hypothetical diagnosis scenario).
Secondary outcome [2] 330702 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 [2] 330702 0
Immediately following intervention (10-15 minutes after participants are presented with the hypothetical diagnosis scenario).
Secondary outcome [3] 330703 0
Personal/family history of cancer. Multiple choice question.
Timepoint [3] 330703 0
Immediately following intervention (10-15 minutes after participants are presented with the hypothetical diagnosis scenario).
Secondary outcome [4] 333081 0
Self-rated general health from the 36-item short form survey instrument (SF-36)
Timepoint [4] 333081 0
Immediately following intervention (10-15 minutes after participants are presented with the hypothetical diagnosis scenario).
Secondary outcome [5] 333082 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 [5] 333082 0
Immediately following intervention (10-15 minutes after participants are presented with the hypothetical diagnosis scenario).
Secondary outcome [6] 333083 0
Numeracy. Measured using questions from the Objective Numeracy Scale. Lipkus IM, Samsa G, Rimer BK. General performance on a numeracy scale among highly educated samples. Medical Decision Making, 2001;21:37-44.
Timepoint [6] 333083 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 Survey Sampling International. 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 the survey company (Survey Sampling International). 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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/03/2017
Actual
3/04/2017
Date of last participant enrolment
Anticipated
Actual
20/04/2017
Date of last data collection
Anticipated
Actual
20/04/2017
Sample size
Target
2000
Accrual to date
Final
2054
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 295322 0
Government body
Name [1] 295322 0
National Health and Medical Research Council (NHMRC) Program Grant APP1113532
Country [1] 295322 0
Australia
Primary sponsor type
University
Name
Sydney School of Public Health, University of Sydney
Address
University of Sydney
NSW
2006
Country
Australia
Secondary sponsor category [1] 294144 0
None
Name [1] 294144 0
Nil
Address [1] 294144 0
Nil
Country [1] 294144 0
Other collaborator category [1] 279387 0
Individual
Name [1] 279387 0
A/Prof Juan P Brito
Address [1] 279387 0
Endocrinology & Metabolism, Mayo Clinic
200 1st Street SW
Rochester, MN
55905
Country [1] 279387 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296654 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 296654 0
University of Sydney
NSW
2006
Ethics committee country [1] 296654 0
Australia
Date submitted for ethics approval [1] 296654 0
03/11/2016
Approval date [1] 296654 0
08/12/2016
Ethics approval number [1] 296654 0
2016/970

Summary
Brief summary
Purpose of the study: The proposed study will produce new data on what attributes (including terminology and risks) are driving papillary thyroid cancer treatment preferences, the trade-offs between risks of treatment that people are willing to accept, and how changes in terminology and risks can lead to changes in preferences. This is understanding is important in order to help reduce patient’s anxiety and concern about low-risk conditions and decrease the preference for unnecessary aggressive treatments. The findings will help the medical community understand the power of language which may enable more effect strategies for communication of low-risk disease and its management options.

Who is it for?: You may be eligible to join this study if you are aged 18 years or more, have no history of thyroid cancer.

Study details: All participants in this study will be presented with a survey which includes 12 hypothetical scenarios that describe the diagnosis of papillary thyroid cancer using various terminology with and without the "cancer" term, and with varying attribute levels. The order in which the scenarios will be provided is random (by chance). Each scenario and the treatment options presented to participants will be identical with the only difference being the terminology used and the levels at which each attribute is set. Following the scenarios participants will be asked a range of socio-demographic questions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71642 0
Prof Kirsten McCaffery
Address 71642 0
307F Edward Ford Building (A27)
University of Sydney
NSW 2006
Country 71642 0
Australia
Phone 71642 0
+61 2 9351 7220
Fax 71642 0
Email 71642 0
[email protected]
Contact person for public queries
Name 71643 0
Kirsten McCaffery
Address 71643 0
307F Edward Ford Building (A27)
University of Sydney
NSW 2006
Country 71643 0
Australia
Phone 71643 0
+61 2 9351 7220
Fax 71643 0
Email 71643 0
[email protected]
Contact person for scientific queries
Name 71644 0
Kirsten McCaffery
Address 71644 0
307F Edward Ford Building (A27)
University of Sydney
NSW 2006
Country 71644 0
Australia
Phone 71644 0
+61 2 9351 7220
Fax 71644 0
Email 71644 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.