Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06411834 |
| Other study ID # |
22-001913 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2025 |
| Est. completion date |
January 2027 |
Study information
| Verified date |
May 2024 |
| Source |
University of California, Los Angeles |
| Contact |
James Wu, MD |
| Phone |
303-518-3186 |
| Email |
jameswu[@]mednet.ucla.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
