None listed
Conditions
Brief summary
This study will investigate the acceptability and impact of a hybrid paper- and web-based Australian Decision Aid on shared decision making for low-risk Papillary Thyroid Cancer Who is it for? You may be eligible to join this study if you are aged 18 years or above with a clinical suspicion of low-risk thyroid cancer Study details Participants in this study will be allocated to one of two groups based on the time point of clinical review: one group will receive standard care, where a decision on thyroid treatment is made in consultation with the patient's clinician. The other group will be provided with a hybrid (paper and web-based) decision aid for initial management of low-risk thyroid cancer. These decision aids will assist in providing the patient with relevant information and awareness, therefore creating choices for patients and their individual preferences. Information is tailored to patients and their treatment options, to enable shared decision making with their specialist. Clinicians’ and patients’ acceptability of the support aids in clinical practice will be assessed. Patients will answer questionnaires to determine decisional conflict, regret, satisfaction and health related quality of life. Total thyroidectomy remains the predominant procedure, despite recent guidelines advocating a de-escalation approach to thyroid cancer surgery. Treatment decision making in low-risk thyroid cancer is complex. This research will address the information gap in low-risk thyroid cancer management and examine the effect of a patient decision aid on the clinical encounter.
Interventions
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.
Sponsors
Study design
Eligibility
Inclusion criteria
-Patients aged >=18 years -with a clinical suspicion of low-risk thyroid cancer according to ATA guidelines (Bethesda 5 or 6 cytology)
Exclusion criteria
Clinical suspicion NOT considered Low risk