The Effect of Surgeon Emotional Support on Treatment Choice for Low-risk Thyroid Cancer
6 other identifiers
interventional
126
1 country
1
Brief Summary
118 adults with benign thyroid nodules who were seen at a UW Health clinic for a fine needle biopsy and do not need surgery will be enrolled and can expect to be on study for a one-time visit of up to 60 minutes. Each participant will be randomized to watch one of two videos simulating a patient-surgeon discussion about treatment options for low-risk thyroid cancer with or without emotionally supportive statements.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2021
CompletedStudy Start
First participant enrolled
November 17, 2021
CompletedFirst Posted
Study publicly available on registry
November 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 7, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 7, 2023
CompletedResults Posted
Study results publicly available
April 3, 2024
CompletedApril 3, 2024
April 1, 2024
1.2 years
November 12, 2021
January 26, 2024
April 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment Choice
The investigators will measure which treatment participants would choose if they were the patient with thyroid cancer in the video (total thyroidectomy or lobectomy) immediately after they finish watching the video.
post video intervention (up to 60 minutes during the only study visit)
Secondary Outcomes (5)
Participant Decisional Confidence Score
post video intervention (up to 60 minutes during the only study visit)
State Trait Anxiety Inventory Brief (STAI Brief) Score
measured at baseline and after video intervention (during 1 day study visit)
Adapted Thyroid Cancer Fear Scale Score
measured at baseline and after video intervention (during 1 day study visit)
Adapted Jefferson Scale of Patient's Perceptions of Physician's Empathy Score
post video intervention (up to 60 minutes during the only study visit)
Adapted Trust in Physician Scale Score
post video intervention (up to 60 minutes during the only study visit)
Study Arms (2)
Standard Video
ACTIVE COMPARATORA video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITHOUT emotionally supportive statements
Emotionally Supportive Video
EXPERIMENTALA video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITH emotionally supportive statements
Interventions
The video is approximately 6 1/2 minutes in length and portrays an emotionally supportive conversation between a patient and surgeon during which the surgeon discusses: the diagnosis, prognosis, available treatment options, benefits and harms of the options, and need for decision making. The surgeon speaks for the majority of the simulated visit and discusses total and hemi-thyroidectomy with the addition of emotionally supportive statements and gestures.
The video is approximately 5 minutes in length and portrays a standard conversation between a patient and surgeon during which the surgeon discusses: the diagnosis, prognosis, available treatment options, benefits and harms of the options, and need for decision making. The surgeon speaks for the majority of the simulated visit and discusses total and hemi-thyroidectomy.
Eligibility Criteria
You may qualify if:
- Seen in a UW Health Clinic for fine needle aspiration (FNA) of a thyroid nodule in the last 30 days
- Thyroid nodule measures ≤4 centimeters
- Benign thyroid nodule biopsy result
- Able to speak and read English
- Access to internet
- Seen in a UW Health Clinic for FNA of a thyroid nodule in the last 30 days
You may not qualify if:
- Additional thyroid nodule biopsy results that are not benign
- History of thyroid cancer
- History of thyroid surgery
- Has seen a surgeon about thyroid or parathyroid surgery
- Has a referral to see a surgeon about thyroid surgery
- Deaf
- Blind
- Vulnerable populations such as prisoners
- History of thyroid cancer
- History of thyroid surgery
- Has seen a surgeon about thyroid or parathyroid surgery
- Plans to see a surgeon about thyroid surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Wisconsin, Madisonlead
- National Cancer Institute (NCI)collaborator
- University of Michigancollaborator
Study Sites (1)
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Corrine Voils, PhD
- Organization
- UW School of Medicine and Public Health
Study Officials
- PRINCIPAL INVESTIGATOR
Corrine Voils, PhD
UW School of Medicine and Public Health
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2021
First Posted
November 24, 2021
Study Start
November 17, 2021
Primary Completion
February 7, 2023
Study Completion
February 7, 2023
Last Updated
April 3, 2024
Results First Posted
April 3, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- After the completion of the primary endpoint.
Data collected for this study will be transferred and analyzed at the University of Michigan. After the study is completed, the de-identified, archived data may be transmitted to and stored at a data repository for use by other researchers including those outside of the study. Permission to transmit data to the University of Michigan and data repository will be included in the informed consent.