Thyroid CancerNCT05132478
The Effect of Surgeon Emotional Support on Treatment Choice for Low-risk Thyroid Cancer
A study testing Emotionally Supportive Video and Standard Video in people with Thyroid Cancer and Thyroid Nodule, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer, Thyroid Nodule, Benign Thyroid Nodule
- What is being tested?
- Emotionally Supportive Video and Standard Video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2021to 7 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
About this study
Official title: The Effect of Surgeon Emotional Support on Treatment Choice for Low-risk Thyroid Cancer: a Randomized Hypothetical Choice Experiment
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.
Read the 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.
- Conditions
- Thyroid Cancer, Thyroid Nodule, Benign Thyroid Nodule
- Being tested
- Emotionally Supportive Video, Standard Video
- Keywords
- thyroid cancer, low-risk, thyroidectomy, emotional support, treatment
- Medical subject headings
- Thyroid Neoplasms, Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotionally Supportive VideoOther
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 VideoOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Video | Active comparator | A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITHOUT emotionally supportive statements Receives: Other: Standard Video |
| Emotionally Supportive Video | Experimental | A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITH emotionally supportive statements Receives: Other: Emotionally Supportive Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: post video intervention (up to 60 minutes during the only study visit)
Secondary outcomes (5)
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'
Measured: post video intervention (up to 60 minutes during the only study visit)
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.
Measured: 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: 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.
Measured: 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.
Measured: post video intervention (up to 60 minutes during the only study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start17 Nov 2021
- Primary completion7 Feb 2023
- Study completion7 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Michigan
- Responsible party
- Sponsor
- Investigators
- Corrine Voils, PhD, Principal investigator, UW School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05132478
- Sponsor's protocol ID
- UW21090
- Other IDs
- A539722, Protocol Version 11/8/2021, K08CA230204, 2021-1079, NCI-2022-02184
- Status last verified
- Apr 2024
- First submitted
- 12 Nov 2021
- Last updated
- 3 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39236399
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Surgeon Emotional Support on Treatment Choice for Low-risk Thyroid Cancer: a Randomized Hypothetical Choice Experiment
- ClinicalTrials.gov ID
- NCT05132478
- Acronym / sponsor ID
- UW21090
- Conditions
- Thyroid Cancer, Thyroid Nodule, Benign Thyroid Nodule
- Keywords
- thyroid cancer, low-risk, thyroidectomy, emotional support, treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Michigan
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 7 Feb 2023 (actual)
- Study completion
- 7 Feb 2023 (actual)
- First posted
- 24 Nov 2021 (actual)
- Results
- Posted 3 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Video | Active comparator | Other: Standard VideoA video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITHOUT emotionally supportive statements |
| Emotionally Supportive Video | Experimental | Other: Emotionally Supportive VideoA video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITH emotionally supportive statements |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotionally Supportive VideoThe 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. | Other | Emotionally Supportive Video |
| Standard VideoThe 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. | Other | Standard Video |
Primary outcome
Treatment Choice
Time frame: 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.
5 secondary outcomes
Participant Decisional Confidence Score
Time frame: post video intervention (up to 60 minutes during the only study visit)
State Trait Anxiety Inventory Brief (STAI Brief) Score
Time frame: measured at baseline and after video intervention (during 1 day study visit)
Adapted Thyroid Cancer Fear Scale Score
Time frame: measured at baseline and after video intervention (during 1 day study visit)
Adapted Jefferson Scale of Patient's Perceptions of Physician's Empathy Score
Time frame: post video intervention (up to 60 minutes during the only study visit)
Adapted Trust in Physician Scale Score
Time frame: post video intervention (up to 60 minutes during the only study visit)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39236399Evans 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corrine Voils, PhD principal investigator
UW School of Medicine and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotionally Supportive Video and Standard Video in people with Thyroid Cancer and Thyroid Nodule, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Choice (time frame: post video intervention (up to 60 minutes during the only study visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05132478, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.