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

University of Wisconsin (UW)

Status: Completed

Conditions: Thyroid Nodule; Thyroid Cancer; Benign Thyroid Nodule

Treatments: Other: Emotionally Supportive Video; Other: Standard Video

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05132478

UW21090

A539722 (Other Identifier)

2021-1079

K08CA230204 (U.S. NIH Grant/Contract)

NCI-2022-02184 (Registry Identifier)

Protocol Version 11/8/2021 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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126 participants in 2 patient groups

Standard Video

Active Comparator group

Description:

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

Treatment:

Other: Standard Video

Emotionally Supportive Video

Experimental group

Description:

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

Treatment:

Other: Emotionally Supportive Video