Benign Thyroid Nodule, Thyroid Cancer, Thyroid Nodule
Conditions
Keywords
thyroid cancer, low-risk, thyroidectomy, emotional support, treatment
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.
Interventions
OTHEREmotionally 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.
OTHERStandard 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.
Sponsors
National Cancer Institute (NCI)
University of Michigan
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 lobectomy) immediately after they finish watching the video. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled at the University of Wisconsin Carbone Cancer Center from November 2021 to February 2023
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 60 |
| 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. | 58 |
| Total | 118 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 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
| Characteristic | Standard Video | Total | Emotionally Supportive Video |
|---|---|---|---|
| Age, Continuous | 56.7 years STANDARD_DEVIATION 13.3 | 55.2 years STANDARD_DEVIATION 13.8 | 54.2 years STANDARD_DEVIATION 14.3 |
| Education Level Bachelor's Degree | 18 Participants | 36 Participants | 18 Participants |
| Education Level Graduate or PhD | 14 Participants | 33 Participants | 19 Participants |
| Education Level High School Graduate | 4 Participants | 10 Participants | 6 Participants |
| Education Level Some College or Associate's Degree | 19 Participants | 36 Participants | 17 Participants |
| Education Level Some High School or Less | 1 Participants | 1 Participants | 0 Participants |
| Education Level Unknown/Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 56 Participants | 111 Participants | 55 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 2 Participants |
| Hypothyroidism | 4 Participants | 9 Participants | 5 Participants |
| Nodule Size Greater than 2 cm | 27 Participants | 58 Participants | 31 Participants |
| Nodule Size Less than or equal to 2 cm | 19 Participants | 37 Participants | 18 Participants |
| Nodule Size Unknown | 12 Participants | 23 Participants | 11 Participants |
| Number of Participants with Bilateral Nodules | 25 Participants | 54 Participants | 29 Participants |
| Number of Participants with Symptomatic Nodule | 10 Participants | 22 Participants | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 50 Participants | 104 Participants | 54 Participants |
| Region of Enrollment United States | 58 participants | 118 participants | 60 participants |
| Sex: Female, Male Female | 51 Participants | 101 Participants | 50 Participants |
| Sex: Female, Male Male | 7 Participants | 17 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 58 |
| other Total, other adverse events | 0 / 60 | 0 / 58 |
| serious Total, serious adverse events | 0 / 60 | 0 / 58 |
Outcome results
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.
Time frame: post video intervention (up to 60 minutes during the only study visit)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Emotionally Supportive Video | Treatment Choice | Total Thyroidectomy | 54 Participants |
| Emotionally Supportive Video | Treatment Choice | Lobectomy | 6 Participants |
| Standard Video | Treatment Choice | Total Thyroidectomy | 51 Participants |
| Standard Video | Treatment Choice | Lobectomy | 7 Participants |
p-value: 0.72Regression, Logistic
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.
Time frame: post video intervention (up to 60 minutes during the only study visit)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Emotionally Supportive Video | Adapted Jefferson Scale of Patient's Perceptions of Physician's Empathy Score | 34.5 score on a scale | Standard Deviation 5.8 |
| Standard Video | Adapted Jefferson Scale of Patient's Perceptions of Physician's Empathy Score | 25.9 score on a scale | Standard Deviation 9.1 |
p-value: <0.001t-test, 2 sided
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.
Time frame: measured at baseline and after video intervention (during 1 day study visit)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emotionally Supportive Video | Adapted Thyroid Cancer Fear Scale Score | baseline | 26.0 score on a scale | Standard Deviation 7 |
| Emotionally Supportive Video | Adapted Thyroid Cancer Fear Scale Score | Post-Intervention | 24.2 score on a scale | Standard Deviation 7.4 |
| Standard Video | Adapted Thyroid Cancer Fear Scale Score | baseline | 27.0 score on a scale | Standard Deviation 5.5 |
| Standard Video | Adapted Thyroid Cancer Fear Scale Score | Post-Intervention | 25.4 score on a scale | Standard Deviation 6.7 |
Comparison: baselinep-value: 0.41t-test, 2 sided
Comparison: Post-Interventionp-value: 0.351ANOVA
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.
Time frame: post video intervention (up to 60 minutes during the only study visit)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Emotionally Supportive Video | Adapted Trust in Physician Scale Score | 12.0 score on a scale | Standard Deviation 2.6 |
| Standard Video | Adapted Trust in Physician Scale Score | 10.4 score on a scale | Standard Deviation 3.1 |
p-value: <0.001t-test, 2 sided
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'
Time frame: post video intervention (up to 60 minutes during the only study visit)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Emotionally Supportive Video | Participant Decisional Confidence Score | 7.6 score on a scale | Standard Deviation 2.1 |
| Standard Video | Participant Decisional Confidence Score | 7.7 score on a scale | Standard Deviation 1.9 |
p-value: 0.743t-test, 2 sided
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.
Time frame: measured at baseline and after video intervention (during 1 day study visit)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emotionally Supportive Video | State Trait Anxiety Inventory Brief (STAI Brief) Score | Baseline | 9.5 score on a scale | Standard Deviation 3.6 |
| Emotionally Supportive Video | State Trait Anxiety Inventory Brief (STAI Brief) Score | Post-Intervention | 12.1 score on a scale | Standard Deviation 4.1 |
| Standard Video | State Trait Anxiety Inventory Brief (STAI Brief) Score | Baseline | 8.8 score on a scale | Standard Deviation 2.7 |
| Standard Video | State Trait Anxiety Inventory Brief (STAI Brief) Score | Post-Intervention | 11.1 score on a scale | Standard Deviation 3.9 |
Comparison: baselinep-value: 0.228t-test, 2 sided
Comparison: Post-Interventionp-value: 0.176t-test, 2 sided