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| ID | Type | Description | Link |
|---|---|---|---|
| A539722 | Other Identifier | UW Madison | |
| Protocol Version 11/8/2021 | Other Identifier | UW Madison | |
| K08CA230204 | U.S. NIH Grant/Contract | View source | |
| 2021-1079 | Other Identifier | UW Madison | |
| NCI-2022-02184 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| University of Michigan | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Video | Active Comparator | A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITHOUT emotionally supportive statements |
|
| Emotionally Supportive Video | Experimental | A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITH emotionally supportive statements |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emotionally Supportive Video | Other | 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. |
| 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) |
| 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) |
| State Trait Anxiety Inventory Brief (STAI Brief) Score |
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Inclusion Criteria (Determined during electronic medical record (EMR) screening):
Inclusion Criteria (Determined/reconfirmed during pre-study screening on Qualtrics):
Exclusion Criteria (Determined during EMR screening):
Exclusion Criteria (Reconfirmed during pre-study screening on Qualtrics):
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| Name | Affiliation | Role |
|---|---|---|
| Corrine Voils, PhD | UW School of Medicine and Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | 53792 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39236399 | Derived | Evans EE, Dougherty A, Jensen CB, Sinco B, Robinson N, Ozkan M, Khan I, Roche K, Saucke MC, Bushaw KJ, Antunez AG, Voils CI, Pitt SC. Thyroid Cancer-Related Fear & Anxiety in Patients With Benign Thyroid Nodules: A Mixed-Methods Study. J Surg Res. 2024 Oct;302:805-813. doi: 10.1016/j.jss.2024.07.108. Epub 2024 Sep 4. |
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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.
After the completion of the primary endpoint.
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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 were enrolled at the University of Wisconsin Carbone Cancer Center from November 2021 to February 2023
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline information provided for analysis population.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | post video intervention (up to 60 minutes during the only study visit) |
|
This study involves one study visit that will take up to 60 minutes.
The current study will pose minimal risk to the participants. Although no problems or adverse events are expected, any study related adverse events will be documented and reported to the local IRB per institutional policy.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Emotionally Supportive Video | A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITH emotionally supportive statements |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Corrine Voils, PhD | UW School of Medicine and Public Health | (608) 262-9636 | voils@surgery.wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 8, 2021 | Jan 18, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 22, 2021 | Feb 7, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D016606 | Thyroid Nodule |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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|
| Standard Video | Other | 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. |
|
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) |
| 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) |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Education Level | Count of Participants | Participants |
|
| Number of Participants with Bilateral Nodules | Count of Participants | Participants |
|
| Nodule Size | Number of participants who self-reported that their largest nodule biopsied was in the size category indication: less than or equal to 2 cm, greater than 2 cm, or unknown (meaning that the patient did not know). | Count of Participants | Participants |
|
| Number of Participants with Symptomatic Nodule | Participants were asked: Before your thyroid nodule(s) was biopsied, were you experiencing any symptoms from your thyroid nodule(s)? Symptoms might include problems with your swallowing, voice, or neck pressure. | Count of Participants | Participants |
|
| Hypothyroidism | Count of Participants | Participants |
|
|
|
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| 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' | Posted | Mean | Standard Deviation | score on a scale | post video intervention (up to 60 minutes during the only study visit) |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | measured at baseline and after video intervention (during 1 day study visit) |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | measured at baseline and after video intervention (during 1 day study visit) |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | post video intervention (up to 60 minutes during the only study visit) |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | post video intervention (up to 60 minutes during the only study visit) |
|
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | Standard Video | A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITHOUT emotionally supportive statements | 0 | 58 | 0 | 58 | 0 | 58 |
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| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| 0.176 |
| Superiority |
| 0.351 |
| Superiority |