Mapping Patient Decision-making in Thyroid Cancer

Mapping Patient Decision-making in Thyroid Cancer: Improving Decision Outcomes Through Ethnographic Decision Modeling

The incidence of thyroid cancer has exploded in the past 5 decades, with a roughly three-fold increase since 1995. Fortunately, many new cases are small, early-stage thyroid cancers. The American Thyroid Association guidelines state that patients with papillary thyroid cancers less than 4 cm can choose either thyroid lobectomy or total thyroidectomy. However, it is unclear why patients will sometimes choose more aggressive treatments that carry additional operative risk when a less aggressive option is available. When investigators examined thyroid specialists' recommendations for thyroid cancer treatment, investigators found significant variation between physicians' risk estimates and their treatment recommendations. This illustrated that patients may receive inconsistent counseling regarding their diagnosis and treatment options from different providers. Worse yet, other studies have shown that patients often do not perceive a choice in their treatment. When patients undergo treatments that do not align with their own priorities and values, they may experience regret and low satisfaction. Decision aids have been shown to help patients feel more educated about their options but have not had an effect on their treatment choice, decision regret, or satisfaction.

The aim of this study is to use an ethnographic approach to map the patient decision-making process and develop a Decision Navigation Tool to improve decision outcomes for thyroid cancer patients. An ethnographic approach seeks to understand the social norms, culture, and context that influence these decisions. Investigators will do so in 3 phases: 1) elicit patient decision criteria in selecting initial treatment for thyroid cancer, 2) construction and validation of decision-tree model for initial treatment of thyroid cancer, and 3) pilot randomized controlled trial of a Decision Navigation Tool. To construct the decision model, investigators will recruit a diverse sample of patients with varying age, gender, race/ethnicity, and operative and cancer outcomes. The Decision Navigation Tool will highlight patients' values and priorities and empower them to select a treatment aligned with their preferences. This study will provide important insights into the patient experience of decision-making in thyroid cancer and test the feasibility of a future multi-center large-scale clinical trial of a Decision Navigation Tool to improve decision outcomes.

Study Overview

• Status: Not yet recruiting
• Conditions: Thyroid Cancer
• Intervention / Treatment: Behavioral: Decision navigation tool

Detailed Description

The incidence of thyroid cancer has exploded in the past 5 decades, with a roughly three-fold increase since 1995. Fortunately, many new cases are small, early-stage thyroid cancers. The American Thyroid Association guidelines state that patients with papillary thyroid cancers less than 4 cm can choose either thyroid lobectomy or total thyroidectomy. However, it is unclear why patients will sometimes choose more aggressive treatments that carry additional operative risk when a less aggressive option is available. When investigators examined thyroid specialists' recommendations for thyroid cancer treatment, investigators found significant variation between physicians' risk estimates and their treatment recommendations. This illustrated that patients may receive inconsistent counseling regarding their diagnosis and treatment options from different providers. Worse yet, other studies have shown that patients often do not perceive a choice in their treatment. When patients undergo treatments that do not align with their own priorities and values, they may experience regret and low satisfaction. Decision aids have been shown to help patients feel more educated about their options but have not had an effect on their treatment choice, decision regret, or satisfaction.

The aim of this study is to use an ethnographic approach to map the patient decision-making process and develop a Decision Navigation Tool to improve decision outcomes for thyroid cancer patients. An ethnographic approach seeks to understand the social norms, culture, and context that influence these decisions. Investigators will do so in 3 phases: 1) elicit patient decision criteria in selecting initial treatment for thyroid cancer, 2) construction and validation of decision-tree model for initial treatment of thyroid cancer, and 3) pilot randomized controlled trial of a Decision Navigation Tool. To construct the decision model, investigators will recruit a diverse sample of patients with varying age, gender, race/ethnicity, and operative and cancer outcomes. The Decision Navigation Tool will highlight patients' values and priorities and empower them to select a treatment aligned with their preferences. This study will provide important insights into the patient experience of decision-making in thyroid cancer and test the feasibility of a future multi-center large-scale clinical trial of a Decision Navigation Tool to improve decision outcomes.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: James Wu, MD; Phone Number: 303-518-3186; Email: jameswu@mednet.ucla.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age >18
• Newly diagnosed or suspected thyroid cancer

Exclusion Criteria:

• Strong indication for total thyroidectomy
• tumor size >4 cm
• nodal or distant metastases
• evidence of extrathyroidal extension
• Non-English speaking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Decision Navigation Tool; Patients will be asked to complete a decision navigation tool that helps them identify and rank key decision criteria. Then we will use a predictive model to inform patients which initial treatment options similar patients have made, and which choices lead to high satisfaction and low regret.	Behavioral: Decision navigation tool; An electronic, interactive form that guides patients through the major factors that influence their decision-making in thyroid cancer
No Intervention: Usual care; Patients will undergo usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decision satisfaction	University of Ottawa Decisional Conflict Scale	1 year postoperative
Decision satisfaction	University of Ottawa Decisional Conflict Scale	Immediately postoperative
Decision satisfaction	University of Ottawa Decisional Conflict Scale	Two weeks postoperative
Decision regret	University of Ottawa Decisional Conflict Scale	1 year postoperative
Decision regret	University of Ottawa Decisional Conflict Scale	immediately postoperative
Decision regret	University of Ottawa Decisional Conflict Scale	two weeks postoperative postoperative
Rate of guideline concordant care vs guideline discordant care		During study period of 12 months

Collaborators and Investigators

• Sponsor: University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: June 9, 2023
• First Submitted That Met QC Criteria: May 9, 2024
• First Posted (Actual): May 13, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 9, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: decision-making
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Neoplasms
• Other Study ID Numbers: 22-001913

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No