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临床试验/NCT05132478
NCT05132478已完成不适用

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

University of Wisconsin, Madison1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2021年11月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
126
试验地点
1
主要终点
Treatment Choice

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •(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

排除标准

  • •(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
  • •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

研究组 & 干预措施

Standard Video

Active Comparator

A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITHOUT emotionally supportive statements

干预措施: Standard Video (Other)

Emotionally Supportive Video

Experimental

A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITH emotionally supportive statements

干预措施: Emotionally Supportive Video (Other)

结局指标

主要结局

Treatment Choice

时间窗: 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.

次要结局

  • State Trait Anxiety Inventory Brief (STAI Brief) Score(measured at baseline and after video intervention (during 1 day study visit))
  • Participant Decisional Confidence Score(post video intervention (up to 60 minutes during the only study visit))
  • Adapted Thyroid Cancer Fear Scale Score(measured at baseline and after video intervention (during 1 day study visit))
  • Adapted Jefferson Scale of Patient's Perceptions of Physician's Empathy Score(post video intervention (up to 60 minutes during the only study visit))
  • Adapted Trust in Physician Scale Score(post video intervention (up to 60 minutes during the only study visit))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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