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

Primary Purpose

Thyroid Cancer, Thyroid Nodule, Benign Thyroid Nodule

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Emotionally Supportive Video
Standard Video
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Thyroid Cancer focused on measuring thyroid cancer, low-risk, thyroidectomy, emotional support, treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

Sites / Locations

  • University of Wisconsin Carbone Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Video

Emotionally Supportive Video

Arm Description

A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITHOUT emotionally supportive statements

A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITH emotionally supportive statements

Outcomes

Primary Outcome Measures

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 hemithyroidectomy) immediately after they finish watching the video.

Secondary Outcome Measures

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'
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.
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.
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.
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.

Full Information

First Posted
November 12, 2021
Last Updated
February 7, 2023
Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI), University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT05132478
Brief Title
The Effect of Surgeon Emotional Support on Treatment Choice for Low-risk Thyroid Cancer
Official Title
The Effect of Surgeon Emotional Support on Treatment Choice for Low-risk Thyroid Cancer: a Randomized Hypothetical Choice Experiment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 17, 2021 (Actual)
Primary Completion Date
February 7, 2023 (Actual)
Study Completion Date
February 7, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI), University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer, Thyroid Nodule, Benign Thyroid Nodule
Keywords
thyroid cancer, low-risk, thyroidectomy, emotional support, treatment

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Video
Arm Type
Active Comparator
Arm Description
A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITHOUT emotionally supportive statements
Arm Title
Emotionally Supportive Video
Arm Type
Experimental
Arm Description
A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITH emotionally supportive statements
Intervention Type
Other
Intervention Name(s)
Emotionally Supportive Video
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Video
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment Choice
Description
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.
Time Frame
post video intervention (up to 60 minutes during the only study visit)
Secondary Outcome Measure Information:
Title
Participant Decisional Confidence Score
Description
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'
Time Frame
post video intervention (up to 60 minutes during the only study visit)
Title
State Trait Anxiety Inventory brief (STAI brief) Score
Description
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.
Time Frame
measured at baseline and after video intervention (during 1 day study visit)
Title
Adapted Thyroid Cancer Fear Scale Score
Description
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.
Time Frame
measured at baseline and after video intervention (during 1 day study visit)
Title
Adapted Jefferson Scale of Patient's Perceptions of Physician's Empathy Score
Description
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.
Time Frame
post video intervention (up to 60 minutes during the only study visit)
Title
Adapted Trust in Physician Scale Score
Description
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.
Time Frame
post video intervention (up to 60 minutes during the only study visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corrine Voils, PhD
Organizational Affiliation
UW School of Medicine and Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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