Thyroid CancerNCT03905369
Focus on Values to Stimulate Shared Decisions
A study testing Decision aid and SDM booster and Deliberation training in people with Thyroid Cancer, run by Radboud University Medical Center at 11 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Decision aid and SDM booster and Deliberation training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 11 sitesNetherlands
- Study dates
- 1 Mar 2020to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- patients with ATA defined low-risk and patients with multifocal papillary TC in the absence of other adverse features
- patients with asymptomatic or mildly symptomatic RAI-refractory (slowly) progressive metastatic disease
Who cannot join
- 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:
- patients with ATA defined intermediate and high risk
- Decision 3: active surveillance vs. systemic treatment
Show all 10Show fewer
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Netherlands11 sites, 11 recruiting
- Not yet recruiting
AUMC
Amsterdam, North Holland
Willemijn Menke-van der Houven van Oordt, Dr.
- Recruiting
AVL
Amsterdam, North Holland
J de Boer, Dr.
- Recruiting
Rijnstate hospital
Arnhem, Gelderland
Arianne Bon, Dr.
- Recruiting
UMCG
Groningen
Wouter Zandee
- Recruiting
LUMC
Leiden, South Holland
Marieke Snel, Dr.
- Recruiting
MUMC
Maastricht, Limburg
Marleen Kars, Dr.
- Recruiting
CWZ
Nijmegen, Gelderland
Mariel Keemers, Dr.
- Recruiting
Radboudumc
Nijmegen, Gelderland
Rosalie Koot, 02436168171, rosalie.koot@radboudumc.nl
Peep Stalmeier, 024-3666841, peep.stalmeier@radboudumc.nl
- Recruiting
Haga
The Hague, South Holland
Maarten Aken, Dr.
- Recruiting
Catharina hospital
Tilburg, North Brabant
Grard Nieuwenhuijzen, Dr.
- Recruiting
UMC Utrecht
Utrecht
Rachel Leeuwaarde, Dr.
About this study
Official title: 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.
- Conditions
- Thyroid Cancer
- Being tested
- Decision aid and SDM booster, Deliberation training
- Keywords
- shared decision making, quality of life, patient-doctor communication, patient treatment preferences
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision aid and SDM boosterOther
Also called Deliberation training
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.
Deliberation trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Decision aid, SDM booster and deliberation training | Experimental | In the first arm, patients have COMBO, consisting of the decision aid, the SDM-booster, and the values deliberation training for physicians Receives: Other: Decision aid and SDM booster; Other: Deliberation training |
| Deliberation training | Active comparator | In the second arm, patients have the values deliberation training for physicians alone. Receives: Other: Deliberation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2.5 years
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start1 Mar 2020
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905369
- Sponsor's protocol ID
- 11463
- Status last verified
- Oct 2022
- First submitted
- 21 Mar 2019
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Koot A, Ottevanger P, Hermens R, Aarts A, Walraven J, Bonenkamp H, de Wilt J, Nieuwenhuijzen G, van der Veen A, Keemers M, Zandee W, Blanken C, van Aken M, Donders R, Stalmeier P, Netea-Maier R; COMBO study group. Effect of a patient decision aid on shared decision making in patients with differentiated thyroid cancer: a randomized controlled trial. Oncologist. 2026 Apr 10;31(5):oyag126. doi: 10.1093/oncolo/oyag126.
PubMed 41955340
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focus on Values to Stimulate Shared Decisions in Patients With Thyroid Cancer: A Multifaceted COMmunication BOoster (COMBO)
- ClinicalTrials.gov ID
- NCT03905369
- Acronym / sponsor ID
- 11463
- Conditions
- Thyroid Cancer
- Keywords
- shared decision making, quality of life, patient-doctor communication, patient treatment preferences
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Cancer Society
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 5 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decision aid, SDM booster and deliberation training | Experimental | Other: Decision aid and SDM booster, Other: Deliberation trainingIn the first arm, patients have COMBO, consisting of the decision aid, the SDM-booster, and the values deliberation training for physicians |
| Deliberation training | Active comparator | Other: Deliberation trainingIn the second arm, patients have the values deliberation training for physicians alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
- patients with ATA defined low-risk and patients with multifocal papillary TC in the absence of other adverse features
- patients with asymptomatic or mildly symptomatic RAI-refractory (slowly) progressive metastatic disease
Key exclusion criteria (10 listed)
- patients with multifocal TC
- patients with incomplete resection of the primary tumor
- patients with ATA defined intermediate risk or high risk
- patients with ATA defined intermediate and high risk
- Decision 3: active surveillance vs. systemic treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision aid and SDM boosterAlso: Deliberation trainingThe 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 | Decision aid, SDM booster and deliberation training |
| Deliberation trainingThe 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. | Other | Decision aid, SDM booster and deliberation training, Deliberation training |
Primary outcome
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.
5 secondary outcomes
Problem-Solving Decision-Making Scale from Deber
Time frame: 1 year
Knowledge questionnaire about treatment options
Time frame: 1 year
Decision evaluation scale
Time frame: 1 year
Trust in oncologist scale - short form
Time frame: 1 year
3-item Collaborate instrument
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Derived from this study: PubMed 41955340Koot A, Ottevanger P, Hermens R, Aarts A, Walraven J, Bonenkamp H, de Wilt J, Nieuwenhuijzen G, van der Veen A, Keemers M, Zandee W, Blanken C, van Aken M, Donders R, Stalmeier P, Netea-Maier R; COMBO study group. Effect of a patient decision aid on shared decision making in patients with differentiated thyroid cancer: a randomized controlled trial. Oncologist. 2026 Apr 10;31(5):oyag126. doi: 10.1093/oncolo/oyag126.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision aid and SDM booster and Deliberation training in people with Thyroid Cancer, run by Radboud University Medical Center at 11 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rosalie Koot (024-36168171, rosalie.koot@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-item Observer OPTION scale (time frame: 2.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03905369, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023; AzTrials last refreshed its copy on 26 Oct 2026.