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

NCT ID: NCT05132478

Last Updated: 2024-04-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-17

Study Completion Date

2023-02-07

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Thyroid Cancer Thyroid Nodule Benign Thyroid Nodule

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Standard Video

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

Group Type ACTIVE_COMPARATOR

Standard Video

Intervention Type 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.

Emotionally Supportive Video

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

Group Type EXPERIMENTAL

Emotionally Supportive Video

Intervention Type 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.

Interventions

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Emotionally Supportive Video

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.

Intervention Type OTHER

Standard Video

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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


* Seen in a UW Health Clinic for FNA of a thyroid nodule in the last 30 days

Exclusion Criteria

* 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


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Corrine Voils, PhD

Role: PRINCIPAL_INVESTIGATOR

UW School of Medicine and Public Health

Locations

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University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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A539722

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 11/8/2021

Identifier Type: OTHER

Identifier Source: secondary_id

K08CA230204

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2021-1079

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2022-02184

Identifier Type: REGISTRY

Identifier Source: secondary_id

UW21090

Identifier Type: -

Identifier Source: org_study_id

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