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

Sponsor

University of Wisconsin, Madison (Other)

Overall Status

Recruiting

CT.gov ID

NCT05132478

Collaborator

National Cancer Institute (NCI) (NIH), University of Michigan (Other)

118

Enrollment

Location

Arms

23.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Cancer Thyroid Nodule Benign Thyroid Nodule	Other: Emotionally Supportive Video Other: Standard Video	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

118 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Nov 17, 2021

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Treatment Choice [post video intervention (up to 60 minutes during the only study visit)]
The investigators will measure which treatment participants would choose if they were the patient with thyroid cancer in the video (total thyroidectomy or hemithyroidectomy) immediately after they finish watching the video.

Secondary Outcome Measures

Participant Decisional Confidence Score [post video intervention (up to 60 minutes during the only study visit)]
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'
State Trait Anxiety Inventory brief (STAI brief) Score [measured at baseline and after video intervention (during 1 day study visit)]
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.
Adapted Thyroid Cancer Fear Scale Score [measured at baseline and after video intervention (during 1 day study visit)]
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.
Adapted Jefferson Scale of Patient's Perceptions of Physician's Empathy Score [post video intervention (up to 60 minutes during the only study visit)]
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.
Adapted Trust in Physician Scale Score [post video intervention (up to 60 minutes during the only study visit)]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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