Trial Outcomes & Findings for The Effect of Surgeon Emotional Support on Treatment Choice for Low-risk Thyroid Cancer (NCT NCT05132478)
NCT ID: NCT05132478
Last Updated: 2024-04-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
126 participants
Primary outcome timeframe
post video intervention (up to 60 minutes during the only study visit)
Results posted on
2024-04-03
Participant Flow
Participants were enrolled at the University of Wisconsin Carbone Cancer Center from November 2021 to February 2023
555 patients were screened, 221 were deemed eligible and invited to participate, 128 consented, 2 participants discontinued after consent prior to randomization, 126 were randomized to start, 2 participants did not complete the survey, and 6 participants who completed the survey greater than 30 days past biopsy, were excluded because they did not meet the eligibility criteria of needing to be within 30 days of their biopsy.
Participant milestones
| Measure |
Emotionally Supportive Video
A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITH emotionally supportive statements
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
A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITHOUT emotionally supportive statements
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.
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
62
|
|
Overall Study
Completed Survey
|
63
|
61
|
|
Overall Study
Analysis Population
|
60
|
58
|
|
Overall Study
COMPLETED
|
60
|
58
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Emotionally Supportive Video
A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITH emotionally supportive statements
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
A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITHOUT emotionally supportive statements
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.
|
|---|---|---|
|
Overall Study
did not complete survey after consent
|
1
|
1
|
|
Overall Study
excluded from analysis because survey was completed >30 days past biopsy
|
3
|
3
|
Baseline Characteristics
The Effect of Surgeon Emotional Support on Treatment Choice for Low-risk Thyroid Cancer
Baseline characteristics by cohort
| Measure |
Emotionally Supportive Video
n=60 Participants
A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITH emotionally supportive statements
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
n=58 Participants
A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITHOUT emotionally supportive statements
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.
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.2 years
STANDARD_DEVIATION 14.3 • n=99 Participants
|
56.7 years
STANDARD_DEVIATION 13.3 • n=107 Participants
|
55.2 years
STANDARD_DEVIATION 13.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
101 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
111 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
104 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=99 Participants
|
58 participants
n=107 Participants
|
118 participants
n=206 Participants
|
|
Education Level
Some High School or Less
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Education Level
High School Graduate
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Education Level
Some College or Associate's Degree
|
17 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Education Level
Bachelor's Degree
|
18 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Education Level
Graduate or PhD
|
19 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Education Level
Unknown/Not Reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Number of Participants with Bilateral Nodules
|
29 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Nodule Size
Less than or equal to 2 cm
|
18 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Nodule Size
Greater than 2 cm
|
31 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Nodule Size
Unknown
|
11 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Number of Participants with Symptomatic Nodule
|
12 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Hypothyroidism
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 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 lobectomy) immediately after they finish watching the video.
Outcome measures
| Measure |
Emotionally Supportive Video
n=60 Participants
A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITH emotionally supportive statements
|
Standard Video
n=58 Participants
A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITHOUT emotionally supportive statements
|
|---|---|---|
|
Treatment Choice
Total Thyroidectomy
|
54 Participants
|
51 Participants
|
|
Treatment Choice
Lobectomy
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 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'
Outcome measures
| Measure |
Emotionally Supportive Video
n=60 Participants
A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITH emotionally supportive statements
|
Standard Video
n=58 Participants
A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITHOUT emotionally supportive statements
|
|---|---|---|
|
Participant Decisional Confidence Score
|
7.6 score on a scale
Standard Deviation 2.1
|
7.7 score on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Emotionally Supportive Video
n=60 Participants
A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITH emotionally supportive statements
|
Standard Video
n=58 Participants
A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITHOUT emotionally supportive statements
|
|---|---|---|
|
State Trait Anxiety Inventory Brief (STAI Brief) Score
Baseline
|
9.5 score on a scale
Standard Deviation 3.6
|
8.8 score on a scale
Standard Deviation 2.7
|
|
State Trait Anxiety Inventory Brief (STAI Brief) Score
Post-Intervention
|
12.1 score on a scale
Standard Deviation 4.1
|
11.1 score on a scale
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Emotionally Supportive Video
n=60 Participants
A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITH emotionally supportive statements
|
Standard Video
n=58 Participants
A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITHOUT emotionally supportive statements
|
|---|---|---|
|
Adapted Thyroid Cancer Fear Scale Score
baseline
|
26.0 score on a scale
Standard Deviation 7.0
|
27.0 score on a scale
Standard Deviation 5.5
|
|
Adapted Thyroid Cancer Fear Scale Score
Post-Intervention
|
24.2 score on a scale
Standard Deviation 7.4
|
25.4 score on a scale
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Emotionally Supportive Video
n=60 Participants
A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITH emotionally supportive statements
|
Standard Video
n=58 Participants
A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITHOUT emotionally supportive statements
|
|---|---|---|
|
Adapted Jefferson Scale of Patient's Perceptions of Physician's Empathy Score
|
34.5 score on a scale
Standard Deviation 5.8
|
25.9 score on a scale
Standard Deviation 9.1
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Emotionally Supportive Video
n=60 Participants
A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITH emotionally supportive statements
|
Standard Video
n=58 Participants
A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITHOUT emotionally supportive statements
|
|---|---|---|
|
Adapted Trust in Physician Scale Score
|
12.0 score on a scale
Standard Deviation 2.6
|
10.4 score on a scale
Standard Deviation 3.1
|
Adverse Events
Emotionally Supportive Video
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Video
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Corrine Voils, PhD
UW School of Medicine and Public Health
Phone: (608) 262-9636
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place