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

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

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.

Study Overview

• Status: Completed
• Conditions: Thyroid Cancer; Thyroid Nodule; Benign Thyroid Nodule
• Intervention / Treatment: Other: Standard Video; Other: Emotionally Supportive Video

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Carbone Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Video; A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITHOUT emotionally supportive statements	Other: 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.
Experimental: Emotionally Supportive Video; A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITH emotionally supportive statements	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Cancer Institute (NCI); University of Michigan
• Investigators: Principal Investigator: Corrine Voils, PhD, UW School of Medicine and Public Health

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2021
• Primary Completion (Actual): February 7, 2023
• Study Completion (Actual): February 7, 2023

Study Registration Dates

• First Submitted: November 12, 2021
• First Submitted That Met QC Criteria: November 23, 2021
• First Posted (Actual): November 24, 2021

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: treatment; thyroid cancer; thyroidectomy; emotional support; low-risk
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Neoplasms; Thyroid Nodule
• Other Study ID Numbers: UW21090; 2021-1079 (Other Identifier: UW Madison); A539722 (Other Identifier: UW Madison); Protocol Version 11/8/2021 (Other Identifier: UW Madison); K08CA230204 (U.S. NIH Grant/Contract); NCI-2022-02184 (Registry Identifier: NCI CTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: After the completion of the primary endpoint.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No