Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06411834
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2023-06-09
Brief Title:
Mapping Patient Decision-making in Thyroid Cancer
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Mapping Patient Decision-making in Thyroid Cancer Improving Decision Outcomes Through Ethnographic Decision Modeling
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 raceethnicity 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
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 raceethnicity 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 raceethnicity 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
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 raceethnicity 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None