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NCT Number: NCT05132478

The Effect of Surgeon Emotional Support on Treatment Choice for Low-risk Thyroid Cancer

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.

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Key information

Conditions

Thyroid Cancer Benign Thyroid Nodule Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases Thyroid Neoplasms Thyroid Nodule

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Participant Decisional Confidence Score

    Time frame: 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'

  2. State Trait Anxiety Inventory Brief (STAI Brief) Score

    Time frame: 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.

  3. Adapted Thyroid Cancer Fear Scale Score

    Time frame: 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.

  4. 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)

    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.

  5. Adapted Trust in Physician Scale Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Cancer Institute (NCI)
  • University of Michigan

Registry information

Official study title

The Effect of Surgeon Emotional Support on Treatment Choice for Low-risk Thyroid Cancer: a Randomized Hypothetical Choice Experiment

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 24, 2021
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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