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Focus on Values to Stimulate Shared Decisions

Primary Purpose

Thyroid Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Decision aid and SDM booster
Deliberation training
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Cancer focused on measuring shared decision making, quality of life, patient-doctor communication, patient treatment preferences

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rijnstate hospitalRecruiting
  • CWZRecruiting
  • RadboudumcRecruiting
  • MUMCRecruiting
  • Catharina hospitalRecruiting
  • AUMC
  • AVLRecruiting
  • HagaRecruiting
  • LUMCRecruiting
  • UMCGRecruiting
  • UMC UtrechtRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Decision aid, SDM booster and deliberation training

Deliberation training

Arm Description

In the first arm, patients have COMBO, consisting of the decision aid, the SDM-booster, and the values deliberation training for physicians

In the second arm, patients have the values deliberation training for physicians alone.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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).
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
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)

Full Information

First Posted
March 21, 2019
Last Updated
March 30, 2023
Sponsor
Radboud University Medical Center
Collaborators
Dutch Cancer Society
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1. Study Identification

Unique Protocol Identification Number
NCT03905369
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
Dutch Cancer Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer
Keywords
shared decision making, quality of life, patient-doctor communication, patient treatment preferences

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Decision aid, SDM booster and deliberation training
Arm Type
Experimental
Arm Description
In the first arm, patients have COMBO, consisting of the decision aid, the SDM-booster, and the values deliberation training for physicians
Arm Title
Deliberation training
Arm Type
Active Comparator
Arm Description
In the second arm, patients have the values deliberation training for physicians alone.
Intervention Type
Other
Intervention Name(s)
Decision aid and SDM booster
Other Intervention Name(s)
Deliberation training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Deliberation training
Intervention Description
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 Measure Information:
Title
5-item Observer OPTION scale
Description
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.
Time Frame
2.5 years
Secondary Outcome Measure Information:
Title
Problem-Solving Decision-Making Scale from Deber
Description
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.
Time Frame
1 year
Title
Knowledge questionnaire about treatment options
Description
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.
Time Frame
1 year
Title
Decision evaluation scale
Description
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).
Time Frame
1 year
Title
Trust in oncologist scale - short form
Description
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
Time Frame
1 year
Title
3-item Collaborate instrument
Description
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)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rosalie Koot
Phone
024-36168171
Email
rosalie.koot@radboudumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Peep Stalmeier
Phone
024-3666841
Email
peep.stalmeier@radboudumc.nl
Facility Information:
Facility Name
Rijnstate hospital
City
Arnhem
State/Province
Gelderland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arianne Bon, Dr.
Facility Name
CWZ
City
Nijmegen
State/Province
Gelderland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariel Keemers, Dr.
Facility Name
Radboudumc
City
Nijmegen
State/Province
Gelderland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosalie Koot
Phone
02436168171
Email
rosalie.koot@radboudumc.nl
First Name & Middle Initial & Last Name & Degree
Peep Stalmeier
Phone
024-3666841
Email
peep.stalmeier@radboudumc.nl
Facility Name
MUMC
City
Maastricht
State/Province
Limburg
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marleen Kars, Dr.
Facility Name
Catharina hospital
City
Tilburg
State/Province
Noord-Brabant
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grard Nieuwenhuijzen, Dr.
Facility Name
AUMC
City
Amsterdam
State/Province
Noord-Holland
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Willemijn Menke-van der Houven van Oordt, Dr.
Facility Name
AVL
City
Amsterdam
State/Province
Noord-Holland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J de Boer, Dr.
Facility Name
Haga
City
Den-Haag
State/Province
Zuid-Holland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maarten Aken, Dr.
Facility Name
LUMC
City
Leiden
State/Province
Zuid-Holland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marieke Snel, Dr.
Facility Name
UMCG
City
Groningen
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wouter Zandee
Facility Name
UMC Utrecht
City
Utrecht
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Leeuwaarde, Dr.

12. IPD Sharing Statement

Plan to Share IPD
No

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