The Effect of Surgeon Emotional Support on Treatment Choice for Low-risk Thyroid Cancer

Thyroid Cancer Clinical Trial

Official title:

The Effect of Surgeon Emotional Support on Treatment Choice for Low-risk Thyroid Cancer: a Randomized Hypothetical Choice Experiment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05132478
• Other study ID #: UW21090
• Secondary ID: A539722Protocol
• Status: Completed
• Phase: N/A
• Start date: November 17, 2021
• Est. completion date: February 7, 2023

Study information

• Verified date: April 2024
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

In this study, the investigators will test the extent to which emotionally supportive communication from a surgeon is associated with patient preference for total thyroidectomy. The investigators will conduct a hypothetical choice experiment with "analogue" patients, defined as those with a benign thyroid nodule not requiring surgery. Baseline measures will be collected, then participants will be randomized to watch a video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer with or without emotionally supportive statements. The investigators hypothesize that increased emotionally supportive communication by the surgeon will decrease the likelihood of patients choosing total thyroidectomy, reduce anxiety and thyroid cancer fear, and increase decisional confidence, perceived physician empathy, trust in physician, and information recall.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: February 7, 2023
• Est. primary completion date: February 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria (Determined during electronic medical record (EMR) screening):

• 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

Inclusion Criteria (Determined/reconfirmed during pre-study screening on Qualtrics):

• Seen in a UW Health Clinic for FNA of a thyroid nodule in the last 30 days

Exclusion Criteria (Determined during EMR screening):

• 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

Exclusion Criteria (Reconfirmed during pre-study screening on Qualtrics):

• 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

Related Conditions & MeSH terms

• Benign Thyroid Nodule
• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms
• Thyroid Nodule

Intervention

Other:
• Emotionally Supportive Video
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.
• Standard Video
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.

Locations

Country	Name	City	State
United States	University of Wisconsin Carbone Cancer Center	Madison	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Cancer Institute (NCI), University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Participant Decisional Confidence Score	Decisional Confidence in treatment option is measured using a single-item 10-point Likert scale where 1 is 'not confident at all' and 10 is 'completely confident'	post video intervention (up to 60 minutes during the only study visit)
Secondary	State Trait Anxiety Inventory Brief (STAI Brief) Score	The STAI brief is a 6-item survey about how the participant is feeling in the moment (calm, tense, upset, relaxed, content, worried) scored on a 4 point likert scale. The total possible range of scores is 6 to 24 with higher scores indicating higher anxiety.	measured at baseline and after video intervention (during 1 day study visit)
Secondary	Adapted Thyroid Cancer Fear Scale Score	The adapted Thyroid Cancer Fear Scale is a 8-item survey originally designed to assess fear of breast cancer in patients undergoing cancer screening. Items are rated on a 5-point scale from strongly disagree (1) to strongly agree (5) with a total possible range of scores from 8-40 where higher scores indicate increased fear of cancer.	measured at baseline and after video intervention (during 1 day study visit)
Secondary	Adapted Jefferson Scale of Patient's Perceptions of Physician's Empathy Score	This 5-question instrument assesses patient perceptions of physician empathy, scored on a 7-point Likert scale ranging from 'strongly disagree' (1) to 'strongly agree' (7). Items are summed, with a max score of 35, higher values indicate a perception of more empathy.	post video intervention (up to 60 minutes during the only study visit)
Secondary	Adapted Trust in Physician Scale Score	This 5-question instrument assesses patient trust in a physician, scored on a 5-point Likert scale ranging from 'strongly disagree' (1) to 'strongly agree' (5). Responses are summed and scores are on a scale of 5 to 25, with higher values indicating more trust.	post video intervention (up to 60 minutes during the only study visit)