Mapping Patient Decision-making in Thyroid Cancer

NCT06411834 | Not Yet Recruiting

• 1 other identifier: 22-001913
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Thyroid Cancer

Keywords

decision-making

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

Decision Navigation Tool

EXPERIMENTAL

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

Usual care

NO INTERVENTION

Patients will undergo usual care

Interventions

Decision navigation tool BEHAVIORAL

An electronic, interactive form that guides patients through the major factors that influence their decision-making in thyroid cancer

Decision Navigation Tool

Eligibility Criteria

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

You may qualify if:

• Age \>18
• Newly diagnosed or suspected thyroid cancer

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Los Angeles: lead

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

James Wu, MD

CONTACT

303-518-3186; jameswu@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: May 13, 2024
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share