Clinical trial NCT03905369: Focus on Values to Stimulate Shared Decisions
Official title: Focus on Values to Stimulate Shared Decisions in Patients With Thyroid Cancer: A Multifaceted COMmunication BOoster (COMBO)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Cancer
Keywords: shared decision making
quality of life
patient-doctor communication
patient treatment preferences
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Dutch Cancer Society
First posted: 2019-04-05
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Decision 1: total thyroidectomy vs. hemithyroidectomy:

Inclusion Criteria:

* patients with nodules \>1 cm and \<4 cm, with cytology result suspicious or malignant (Bethesda 5 or 6) with no clinical or radiological evidence of pathological lymph nodes and/or distant metastases before the primary (diagnostic) surgery
* patients with histologically (after diagnostic hemithyroidectomy) proven TC but are defined as low-risk according to the ATA classification.

Exclusion criteria:

* patients with multifocal TC
* patients with incomplete resection of the primary tumor
* patients with ATA defined intermediate risk or high risk

Decision 2: no treatment with RAI vs. treatment with RAI:

Inclusion criteria:

• patients with ATA defined low-risk and patients with multifocal papillary TC in the absence of other adverse features

Exclusion criteria:

• patients with ATA defined intermediate and high risk

Decision 3: active surveillance vs. systemic treatment

Inclusion criteria:

• patients with asymptomatic or mildly symptomatic RAI-refractory (slowly) progressive metastatic disease

Exclusion criteria:

• patients with coexisting conditions that do not allow prescription of TKI's

Other exclusion Criteria:

* lack of Dutch language proficiency
* mental incompetence hampering the process of shared decision making as judged by the physician

Primary outcomes:
measure: 5-item Observer OPTION scale
timeFrame: 2.5 years
Secondary outcomes:
measure: Problem-Solving Decision-Making Scale from Deber
timeFrame: 1 year
measure: Knowledge questionnaire about treatment options
timeFrame: 1 year
measure: Decision evaluation scale
timeFrame: 1 year
measure: Trust in oncologist scale - short form
timeFrame: 1 year
measure: 3-item Collaborate instrument
timeFrame: 1 year
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate hospital
state: Gelderland
city: Nijmegen
country: Netherlands
facility: CWZ
state: Gelderland
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
city: Maastricht
country: Netherlands
facility: MUMC
state: Limburg
city: Tilburg
country: Netherlands
facility: Catharina hospital
state: Noord-Brabant
city: Amsterdam
country: Netherlands
facility: AUMC
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: AVL
state: Noord-Holland
city: Den-Haag
country: Netherlands
facility: Haga
state: Zuid-Holland
city: Leiden
country: Netherlands
facility: LUMC
state: Zuid-Holland
city: Groningen
country: Netherlands
facility: UMCG
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
References: