We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Focus on Values to Stimulate Shared Decisions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03905369
Recruitment Status : Recruiting
First Posted : April 5, 2019
Last Update Posted : March 15, 2021
Dutch Cancer Society
Information provided by (Responsible Party):
Radboud University Medical Center

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.

Condition or disease Intervention/treatment Phase
Thyroid Cancer Other: Decision aid and SDM booster Other: Deliberation training Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Focus on Values to Stimulate Shared Decisions in Patients With Thyroid Cancer: A Multifaceted COMmunication BOoster (COMBO)
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : March 1, 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Decision aid, SDM booster and deliberation training
In the first arm, patients have COMBO, consisting of the decision aid, the SDM-booster, and the values deliberation training for physicians
Other: Decision aid and SDM booster
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.
Other Name: Deliberation training

Other: Deliberation training
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.

Active Comparator: Deliberation training
In the second arm, patients have the values deliberation training for physicians alone.
Other: Deliberation training
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.

Primary Outcome Measures :
  1. 5-item Observer OPTION scale [ Time Frame: 2.5 years ]
    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.

Secondary Outcome Measures :
  1. Problem-Solving Decision-Making Scale from Deber [ Time Frame: 1 year ]

    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.

  2. Knowledge questionnaire about treatment options [ Time Frame: 1 year ]
    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.

  3. Decision evaluation scale [ Time Frame: 1 year ]
    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).

  4. Trust in oncologist scale - short form [ Time Frame: 1 year ]
    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

  5. 3-item Collaborate instrument [ Time Frame: 1 year ]
    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)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03905369

Layout table for location contacts
Contact: Rosalie Koot 024-36168171 rosalie.koot@radboudumc.nl
Contact: Peep Stalmeier 024-3666841 peep.stalmeier@radboudumc.nl

Layout table for location information
Rijnstate hospital Recruiting
Arnhem, Gelderland, Netherlands
Contact: Arianne Bon, Dr.         
CWZ Recruiting
Nijmegen, Gelderland, Netherlands
Contact: Mariel Keemers, Dr.         
Radboudumc Recruiting
Nijmegen, Gelderland, Netherlands
Contact: Rosalie Koot    02436168171    rosalie.koot@radboudumc.nl   
Contact: Peep Stalmeier    024-3666841    peep.stalmeier@radboudumc.nl   
MUMC Recruiting
Maastricht, Limburg, Netherlands
Contact: Marleen Kars, Dr.         
Catharina hospital Recruiting
Tilburg, Noord-Brabant, Netherlands
Contact: Grard Nieuwenhuijzen, Dr.         
AUMC Not yet recruiting
Amsterdam, Noord-Holland, Netherlands
Contact: Willemijn Menke-van der Houven van Oordt, Dr.         
AVL Recruiting
Amsterdam, Noord-Holland, Netherlands
Contact: J de Boer, Dr.         
Haga Recruiting
Den-Haag, Zuid-Holland, Netherlands
Contact: Maarten Aken, Dr.         
LUMC Recruiting
Leiden, Zuid-Holland, Netherlands
Contact: Marieke Snel, Dr.         
UMCG Recruiting
Groningen, Netherlands
Contact: Wouter Zandee         
UMC Utrecht Recruiting
Utrecht, Netherlands
Contact: Rachel Leeuwaarde, Dr.         
Sponsors and Collaborators
Radboud University Medical Center
Dutch Cancer Society
Layout table for additonal information
Responsible Party: Radboud University Medical Center
ClinicalTrials.gov Identifier: NCT03905369    
Other Study ID Numbers: 11463
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: March 15, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Radboud University Medical Center:
shared decision making
quality of life
patient-doctor communication
patient treatment preferences
Additional relevant MeSH terms:
Layout table for MeSH terms
Thyroid Neoplasms
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms