Most patients with non-medullary thyroid carcinoma (TC) achieve remission after primary treatment. Nonetheless, 30% develop recurrent disease and/or distant metastases resulting in worse survival. Patients with low- and intermediate-risk, whilst having a good prognosis, generally undergo similar primary treatment as those with a high-risk disease and face the risk of complications and burden of treatment, without a proven benefit in long-term outcome. For these patients, current guidelines state that less aggressive treatment (e.g. hemi-thyroidectomy vs. total thyroidectomy, and selective use of radioiodine (RAI) therapy), and tailored follow-up can be equally acceptable leaving room for patients' preferences. For high- risk patients, important unanswered question regard the optimal timing of starting tyrosine kinase inhibitors (TKI). For those who are asymptomatic or only mildly symptomatic, starting the treatment too early may expose them to side effects and impair quality of life, without evidence of a survival benefit. Different patients have different views on these decisions, and so do physicians. Therefore, care should honour preferences and values of individual patients, and care should involve patients through shared decision making (SDM). The principle of SDM is twofold: 1. physicians provide patients with information on the existing options, and 2. help patients identify their preferences considering their individual values and needs. This involves important life values, for instance the desire to do everything possible, or to minimise complaints. Addressing patients' treatment-related values is arguably the most difficult part of SDM so patient values are less likely to be discussed and honoured in a consultation. Current tools improve values deliberation but their effects are clearly insufficient. Tools should be integrated and applied in consultations to increase effectiveness. To strengthen values deliberation with TC as an example, a multifaceted intervention, COMBO, is proposed including 1) a patient values clarification exercise, named SDM-booster, 2) a physician values deliberation training using the SDM-booster, and 3) a patient decision aid. The SDM-booster strengthens values deliberation by 1) strengthening and clarifying patients' values and preferences, 2) communicating patients' values in the consultation, 3) serving as a focus in the values deliberation training.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
128
The investigators develop the decision aid and SDM booster. The scope of the investigators of decision making combines the clinical and patient perspective. The decision aids are developed for patients with TC either newly diagnosed or patients with advanced disease, presently in the follow-up at the participating centers, covering the whole treatment trajectory of these patients (Figure 4). Three treatment decisions are considered: 1) the extent of thyroid resection, 2) the use of RAI, and 3) the initiation of TKIs.The SDM-booster is developed alongside the decision aids, as the SDM-booster (or values clarification exercise) is often a component developed together with a decision aid. The SDM-booster aims to shape patients' values regarding aspects of the decision and ensuing treatment preferences.
The investigators develop the deliberation training. It makes physicians more aware and responsive to patients' values. The communication training for physicians will consist of 1) an e-learning SDM-training lasting 40 minutes and, 2) an individual values deliberation training lasting 2 hours.
Rijnstate hospital
Arnhem, Gelderland, Netherlands
RECRUITINGCWZ
Nijmegen, Gelderland, Netherlands
RECRUITINGRadboudumc
Nijmegen, Gelderland, Netherlands
RECRUITINGMUMC
Maastricht, Limburg, Netherlands
RECRUITINGCatharina hospital
Tilburg, North Brabant, Netherlands
RECRUITINGAUMC
Amsterdam, North Holland, Netherlands
NOT_YET_RECRUITINGAVL
Amsterdam, North Holland, Netherlands
RECRUITINGLUMC
Leiden, South Holland, Netherlands
RECRUITINGHaga
The Hague, South Holland, Netherlands
RECRUITINGUMCG
Groningen, Netherlands
RECRUITING...and 1 more locations
5-item Observer OPTION scale
Audio recordings of the patient doctor communication. Measuring shared decision making by assessing recordings or transcripts of encounters from clinical settings. Each item is score 0-4 (0= no effort, 1 = minimal effort, 2 = moderate effort, 3 = skilled effort, 4 = exemplary effort), yielding a total between 0-20.
Time frame: 2.5 years
Problem-Solving Decision-Making Scale from Deber
The problem solving decision making scale comprises six tasks, four tasks problem solving and two tasks decision making. All six tasks are evaluated on a 5-point Likert scale, where: 1 = the doctor alone; 2 = mostly the doctor; 3 = both equally; 4 = mostly me and 5 = me alone.
Time frame: 1 year
Knowledge questionnaire about treatment options
Objective knowledge will be measured with 5 right/wrong items about the three treatment decisions (hemithyroidectomy/total thyroidectomy, RAI/no RAI, active surveillance/TKI). These items will be generated by a panel of experts not involved in the development of the decision aid.
Time frame: 1 year
Decision evaluation scale
The Decision Evaluation Scales comprise the Satisfaction- Uncertainty, Informed Choice, and Decision Control scale. Each scale contain five items asking about the decision between screening and prohylactic mastectomy. Responses were on a 5- point scale ranging from 1 (strongly disagree) to 5 (strongly agree).
Time frame: 1 year
Trust in oncologist scale - short form
This scale assesses cancer patients' trust in their oncologist, it's a 5-item measure. Each item is scored on a five-point Likert scale: 1 = totally disagree, 2 = disagree, 3 = as much agree as disagree, 4 = agree, 5 = strongly agree
Time frame: 1 year
3-item Collaborate instrument
Patient's subjective evaluation of shared decision making process. Each item is scored 0-4 (0 = no effort was made, 1 = a little effort was made, 2 = some effort was made, 3 = a lot of effort was made, and 4 = every effort was made)
Time frame: 1 year
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