Clinical trial NCT06411834: Mapping Patient Decision-making in Thyroid Cancer
Official title: Mapping Patient Decision-making in Thyroid Cancer: Improving Decision Outcomes Through Ethnographic Decision Modeling
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Thyroid Cancer
Keywords: decision-making
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2024-05-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Decision satisfaction
timeFrame: 1 year postoperative
measure: Decision satisfaction
timeFrame: Immediately postoperative
measure: Decision satisfaction
timeFrame: Two weeks postoperative
measure: Decision regret
timeFrame: 1 year postoperative
measure: Decision regret
timeFrame: immediately postoperative
measure: Decision regret
timeFrame: two weeks postoperative postoperative
measure: Rate of guideline concordant care vs guideline discordant care
timeFrame: During study period of 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: