Thyroid Cancer Clinical Trial
Official title:
The Effect of Surgeon Emotional Support on Treatment Choice for Low-risk Thyroid Cancer: a Randomized Hypothetical Choice Experiment
Verified date | April 2024 |
Source | University of Wisconsin, Madison |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 126 |
Est. completion date | February 7, 2023 |
Est. primary completion date | February 7, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin Carbone Cancer Center | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison | National Cancer Institute (NCI), University of Michigan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | post video intervention (up to 60 minutes during the only study visit) | |
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' | 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. | 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. | 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. | 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. | post video intervention (up to 60 minutes during the only study visit) |
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