Focus on Values to Stimulate Shared Decisions

NCT03905369 | Unknown DMC

• 1 other identifier: 11463
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 11

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.

Conditions

Thyroid Cancer

Keywords

shared decision making; quality of life; patient-doctor communication; patient treatment preferences

Outcome Measures

Primary Outcomes (1)

• 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.

  2.5 years

Secondary Outcomes (5)

• Problem-Solving Decision-Making Scale from Deber

  1 year

• Knowledge questionnaire about treatment options

  1 year

• Decision evaluation scale

  1 year

• Trust in oncologist scale - short form

  1 year

• 3-item Collaborate instrument

  1 year

Study Arms (2)

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

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.

Other: Deliberation training

Interventions

Decision aid and SDM booster OTHER

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.

Also known as: Deliberation training

Decision aid, SDM booster and deliberation training

Deliberation training OTHER

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.

Decision aid, SDM booster and deliberation training; Deliberation training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 low-risk and patients with multifocal papillary TC in the absence of other adverse features
• patients with ATA defined intermediate and high risk
• Decision 3: active surveillance vs. systemic treatment
• patients with asymptomatic or mildly symptomatic RAI-refractory (slowly) progressive metastatic disease
• patients with coexisting conditions that do not allow prescription of TKI's
• lack of Dutch language proficiency
• mental incompetence hampering the process of shared decision making as judged by the physician

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Dutch Cancer Society: collaborator

Study Sites (11)

Rijnstate hospital

Arnhem, Gelderland, Netherlands

RECRUITING

CWZ

Nijmegen, Gelderland, Netherlands

RECRUITING

Radboudumc

Nijmegen, Gelderland, Netherlands

RECRUITING

MUMC

Maastricht, Limburg, Netherlands

RECRUITING

Catharina hospital

Tilburg, North Brabant, Netherlands

RECRUITING

AUMC

Amsterdam, North Holland, Netherlands

NOT YET RECRUITING

AVL

Amsterdam, North Holland, Netherlands

RECRUITING

LUMC

Leiden, South Holland, Netherlands

RECRUITING

Haga

The Hague, South Holland, Netherlands

RECRUITING

UMCG

Groningen, Netherlands

RECRUITING

UMC Utrecht

Utrecht, Netherlands

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Rosalie Koot

CONTACT

024-36168171; rosalie.koot@radboudumc.nl

Peep Stalmeier

CONTACT

024-3666841; peep.stalmeier@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: April 5, 2019
• Study Start: March 1, 2020
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: April 3, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (11)