Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001356550
Ethics application status
Approved
Date submitted
9/10/2024
Date registered
13/11/2024
Date last updated
13/11/2024
Date data sharing statement initially provided
13/11/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Australian Decision Aid for low-risk Papillary Thyroid Cancer
Impact on the use of a Decision Aid in Adult patients with Low Risk Thyroid cancer
Scientific title
Australian Decision Aid for low-risk Papillary Thyroid Cancer
A real-world trial investigating acceptability and impact on shared decision making
Secondary ID [1] 312560 0
ADAPT Clinical Trial Protocol Version 2.1 3 August 2024
Universal Trial Number (UTN)
Trial acronym
ADAPT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thyroid cancer 334457 0
Condition category
Condition code
Metabolic and Endocrine 331077 331077 0 0
Thyroid disease
Cancer 332111 332111 0 0
Thyroid

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To evaluate a hybrid (paper and web-based) decision aid for initial management of low-risk thyroid cancer (“the Decision Aid") within clinical practice, assessing its acceptability and effect on shared decision making including decisional conflict, regret, satisfaction.
Thyroid cancer has very good outcomes and recent guidelines have suggested that patients can chose between active surveillance (no surgery by regular follow-up), hemithyroidectomy (removal of the half of the thyroid containing the cancer) or total thyroidectomy (removal of the whole thyroid). Prior research has identified a gap in information resources available to both clinicians and patients when making this decision. We have developed decision support tools to assist patients and clinicians in the process of shared decision making for low-risk thyroid cancer. We have collected patient and clinician feedback and developed a paper and web-based decision aid. Decision aids aim to enhance shared decision-making by improving information sharing and clinician-patient communication. Recognising that surgeons and patients have varied information needs and communication styles, a two-page paper aid and a detailed website were developed and revised over three years. The paper aid is meant for use during specialist consultations, tailored to each patient’s context, while the website allows patients to explore additional information at their own pace. The intervention in this study is both the paper and web based decision aids.
The website can be found at:
https://thyroidology.au/thyroid_aid/
During the one-on-one, face to face clinical encounter with the patients specialist, patients will be screened and recruited into the study by the specialist based on eligibility. This is potentially a single consultation. Patients choosing to participate will be sent an email that contains a link to study information and the first set of surveys. Participants that consent to this study will be asked to complete 6 x survey questionnaires at two timepoints: baseline and 8-months after consultation. Each survey contains between 5-30 questions. Completion of all surveys will take approximately 10-15 minutes.
Adherence is monitored. Screened patient details will be entered into redcap within 24 hours of the consultation. Patients who have not responded to the initial patient survey within 24 hours will receive a reminder email regarding the survey. Those who have not responded within 72 hours will be sent a SMS and/or called.
There are two phases to this study, the first, the preintervention phase, assesses patients baseline responses prior to the use of the decision aid in practice. During this phase, the decision aid materials will NOT be supplied. This phase is anticipated to take 3 months.
Following this, there will be a “washout phase” where no recruitment will be undertaken. This will allow for clear delineation between the two phases of the study.
The intervention phase will recruit the same target population and assess outcomes with the same surveys, allowing comparisons between the cohorts. During the intervention phase, clinicians and patients will have access to BOTH the paper decision aid materials and the web-based decision aid materials. The intervention phase is anticipated to take 6 months.
Intervention code [1] 329073 0
Treatment: Other
Comparator / control treatment
Standard treatment- no intervention- no decision aids. Surgery is the most common treatment for thyroid cancer. When thyroid cancer is probable based on biopsy results, patients have previously been recommended to undergo total thyroidectomy and radioactive iodine. Thyroid cancer has very good outcomes and hence recent treatments have suggested that patients can chose between active surveillance, hemithyroidectomy or total thyroidectomy .Recent guidelines have advocated for a de-escalation approach to thyroid cancer surgery, as it is now recognised that many thyroid cancers are indolent and over treated.
Control group
Active

Outcomes
Primary outcome [1] 338850 0
-To evaluate acceptability of the Decision Aid for clinicians who have tried to use it, measured as >80% of clinicians planning to continue using the decision aid after six months of use in practice
Timepoint [1] 338850 0
First participant consultation (Baseline) and 8 months post intervention administration
Primary outcome [2] 339701 0
To evaluate the effect of the Decision Aid for patients on decisional conflict.
Timepoint [2] 339701 0
Baseline (without the decision aid) and 8 months post intervention administration
Secondary outcome [1] 437670 0
-To evaluate the impact of the hybrid decision aid on patient decisional regret at 8 months.
Timepoint [1] 437670 0
Clinicians answer survey at baseline (pre-intervention phase) followed by second clinician survey in the final week of the intervention phase (8 months). Patients answer survey at baseline (pre-intervention phase) followed by second patient survey in the final week of the intervention phase (8 months)
Secondary outcome [2] 440941 0
-To evaluate the impact of the hybrid decision aid on patient health-related quality of life.
Timepoint [2] 440941 0
First participant consultation (baseline) and 8 months post intervention administration
Secondary outcome [3] 440942 0
-To evaluate the impact of the hybrid decision aid on patient fear of cancer recurrence
Timepoint [3] 440942 0
First participant consultation (baseline) and 8 months post intervention administration
Secondary outcome [4] 440943 0
-To explore the impact of clinician-patient concordance as measured by maximiser-minimiser tendencies for both patients and clinicians on decision making, decisional conflict and regret.
Timepoint [4] 440943 0
First participant consultation (baseline) and 8 months post intervention administration
Secondary outcome [5] 440944 0
To evaluate the impact of the hybrid decision making for patients
Timepoint [5] 440944 0
First participant consultation (baseline) and 8 months post intervention administration

Eligibility
Key inclusion criteria
-Patients aged >=18 years
-with a clinical suspicion of low-risk thyroid cancer according to ATA guidelines (Bethesda 5 or 6 cytology)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clinical suspicion NOT considered Low risk

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
21/09/2024
Date of last participant enrolment
Anticipated
27/12/2024
Actual
Date of last data collection
Anticipated
31/08/2025
Actual
Sample size
Target
150
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 316987 0
Government body
Name [1] 316987 0
NSW Regional Cancer Research Network
Country [1] 316987 0
Australia
Primary sponsor type
Government body
Name
NSW Regional Cancer Research Network
Address
Country
Australia
Secondary sponsor category [1] 319234 0
None
Name [1] 319234 0
Address [1] 319234 0
Country [1] 319234 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315741 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 315741 0
Ethics committee country [1] 315741 0
Australia
Date submitted for ethics approval [1] 315741 0
03/08/2024
Approval date [1] 315741 0
15/08/2024
Ethics approval number [1] 315741 0

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

Contacts
Principal investigator
Name 135666 0
A/Prof Christine O.Neill
Address 135666 0
Surgical Services John Hunter Hospital Locked Bag1 Hunter Region Mail Centre 2310 NSW
Country 135666 0
Australia
Phone 135666 0
+61 0249236397
Fax 135666 0
Email 135666 0
[email protected]
Contact person for public queries
Name 135667 0
Michelle Chapman
Address 135667 0
Surgical Services John Hunter Hospital Locked Bag1 Hunter Region Mail Centre 2310 NSW
Country 135667 0
Australia
Phone 135667 0
+61 0249236397
Fax 135667 0
Email 135667 0
[email protected]
Contact person for scientific queries
Name 135668 0
Christine O'Neill
Address 135668 0
Surgical Services John Hunter Hospital Locked Bag1 Hunter Region Mail Centre 2310 NSW
Country 135668 0
Australia
Phone 135668 0
+61 0249236397
Fax 135668 0
Email 135668 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Other approved surgical researchers

Conditions for requesting access:
• -

What individual participant data might be shared?
• All outcome data

What types of analyses could be done with individual participant data?
• Descriptive analysis

When can requests for individual participant data be made (start and end dates)?
From:
No end date. Post publication of study results.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.