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The Effect of Surgeon Emotional Support on Treatment Choice for Low-risk Thyroid Cancer
NA trial testing Emotionally Supportive Video in Thyroid Cancer in 126 participants. Completed in 7 February 2023.
| Lead sponsor | University of Wisconsin, Madison |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | health services research |
| Enrollment | 126 |
| Start date | 17 November 2021 |
| Primary completion | 7 February 2023 |
| Estimated completion | 7 February 2023 |
| Sites | 1 location across United States |
University of Wisconsin, Madison
18 and older, any sex, with Thyroid Cancer or Thyroid Nodule. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Emotionally Supportive Video | 54 | |
| Standard Video | 51 | |
| Emotionally Supportive Video | 6 | |
| Standard Video | 7 |
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'
| Group | Value | 95% CI |
|---|---|---|
| Emotionally Supportive Video | 7.6 | ± 2.1 |
| Standard Video | 7.7 | ± 1.9 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Emotionally Supportive Video | 9.5 | ± 3.6 |
| Standard Video | 8.8 | ± 2.7 |
| Group | Value | 95% CI |
|---|---|---|
| Emotionally Supportive Video | 12.1 | ± 4.1 |
| Standard Video | 11.1 | ± 3.9 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Emotionally Supportive Video | 26.0 | ± 7.0 |
| Standard Video | 27.0 | ± 5.5 |
| Group | Value | 95% CI |
|---|---|---|
| Emotionally Supportive Video | 24.2 | ± 7.4 |
| Standard Video | 25.4 | ± 6.7 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Emotionally Supportive Video | 34.5 | ± 5.8 |
| Standard Video | 25.9 | ± 9.1 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Emotionally Supportive Video | 12.0 | ± 2.6 |
| Standard Video | 10.4 | ± 3.1 |
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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