Focus on values to stimulate shared decisions in patients with thyroid cancer: A multifaceted
COMmunication BOoster (COMBO)*

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.

Aim: to develop, implement and evaluate COMBO to improve SDM during the
treatment trajectory of TC patients in situations when clear cut
recommendations cannot be made either because the benefits closely balance with
risks, or because this balance cannot be determined based on existing evidence;
to make physicians more aware of patients* values through SDM.

Research questions:
1) Does COMBO result in better SDM (primary outcome) and better decision
outcomes in patients with TC?
2) Does COMBO improve physicians* understanding of what patients with TC find
important?
3) What is the feasibility of COMBO regarding its uptake and what are
experiences of patients with TC and their physicians?

Plan of investigation: In WP1, the decision aids, SDM-booster, and deliberation
training will be developed together with patients, physicians, and experts in
medical decision making and doctor-patient communication. Decision aids are
developed for the care pathway: 1) extent of thyroid resection, 2) initiation
of TKIs for high-risk patients. In WP2, patients with TC are randomised between
COMBO and the training for physicians alone. The decision aid, the SDM-booster,
and baseline questionnaire are sent to patients* home. The baseline measures
contain demographic and clinical characteristics, patient pre-consultation
values, and decision making and safety items. For both arms, the next decision
consultation is audio-recorded and SDM as measured with the OPTION scale is
scored. Physicians*own values and substitute values are also noted. Patients'
post-consultation values and decision outcomes are assessed 1 week after the
consultation by questionnaires sent at home. In WP3, the feasibility of the
uptake of COMBO components is studied using interviews and questionnaires for
patients and physicians. Power: a moderate effect size of 0.5 on OPTION can be
detected with 128 complete patients with an alpha 5%, and a power of 80%. Seven
academic hospitals will participate in the study, and 224 patients will be
approached for participation.

The intervention consists of a decision aid, a values clarification exercise
(the booster), and the values communication training for physicians.
The decision aid is randomised. We choose for this design because we aim to
evaluate the combined tool, COMBO, against the best alternative care regarding
shared decision making. As communication training is a prevalent strategy to
implement SDM in Dutch health care, we consider communication training as a
standard element of current care. Therefore the values deliberation training
for physicians is present in both arms.

Patients face difficulties to express their values in the patient-doctor
communication. Listening to patient values is a prerequisite for honouring
their treatment preferences, and for personalising their care. Audio-recordings
in clinical practice show that behaviours such as "the physician invites
patient to ask questions; the physician asks for expectations and fears; the
physician asks whether information is understood" are not frequently observed.
Clearly, more powerful tools should be created to improve SDM.
The aim of our study is to facilitate patients to express what matters to
them in the treatment choice. The burden on patients in the intervention group
is that they receive a decision aid: Decision aids have been shown to be save,
and are welcomed by patients.