Thyroid Cancer, Thyroid Nodules
Conditions
Keywords
thyroid nodules, shared decision making
Brief summary
There is an epidemic of thyroid cancer that is harmful to patients and the medical system. The study hypothesizes that the use of an electronic conversation aid during clinical visits can help patients and clinicians collaborate when deciding the next step in management for a thyroid nodule. The study aims to update a conversation aid prototype that was developed to support shared decision making in the diagnosis of thyroid cancer. This entry (Aim 1) has an associated study (Aim 2) registered under NCT04463719
Interventions
This conversation aid will help you and your doctor discuss ways to care for your thyroid nodule. We will evaluate the acceptability of the conversation aid and barriers to implementation in clinical practice. Post visit semi structured interviews and recordings of the clinical visits will be qualitatively analyzed. We hypothesize that the conversation aid will be accepted and facilitate the decision making process.
Sponsors
National Cancer Institute (NCI)
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Adults \>18 years old presenting for evaluation of a thyroid nodule
Exclusion criteria
* Patients with hyperthyroidism * Patients with previous biopsy of the nodule of interest * Pregnant patients * Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative Analysis of the Patient and Clinician Experience Using the Conversation Aid | Up to the time the post visit interview was completed (on average 1 weeks after the clinical visit for patients and 1 month after completion of 3 visit using the tool for clinicians) | The clinical visit and post visit semi-structure interviews of patient and clinicians that have used the conversation aid will be analyzed qualitatively to better understand the acceptability of the conversation aid in clinical practice and used to further update the conversation aid. |
Countries
United States
Participant flow
Recruitment details
The study aims to update a conversation aid prototype that was developed to support shared decision making in the diagnosis of thyroid cancer. Adult patients with thyroid nodules presenting for consultation were recruited from two clinical centers (University of Florida, Gainesville and Mayo Clinic, Rochester). Enrollment started on 07/16/2020 and was completed on 08/02/2021.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group: Patients Counseling using the electronic conversation aid
Counseling using the electronic conversation aid: This conversation aid will help you and your doctor discuss ways to care for your thyroid nodule. We will evaluate the acceptability of the conversation aid and barriers to implementation in clinical practice. Post visit semi structured interviews and recordings of the clinical visits will be qualitatively analyzed. We hypothesize that the conversation aid will be accepted and facilitate the decision making process. | 53 |
| Intervention Group: Clinicians Counseling using the electronic conversation aid
Counseling using the electronic conversation aid: This conversation aid will help you and your patient discuss ways to care for their thyroid nodule. We will evaluate the acceptability of the conversation aid and barriers to implementation in clinical practice. Post visit semi structured interviews and recordings of the clinical visits will be qualitatively analyzed. We hypothesize that the conversation aid will be accepted and facilitate the decision making process. | 13 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 5 |
Baseline characteristics
| Characteristic | Total | Intervention Group: Patients | Intervention Group: Clinicians |
|---|---|---|---|
| Age, Continuous | 62 years | 62 years | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53 Participants | 53 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 13 Participants | 0 Participants | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 5 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 14 Participants | 1 Participants | 13 Participants |
| Race (NIH/OMB) White | 47 Participants | 47 Participants | 0 Participants |
| Sex: Female, Male Female | 50 Participants | 42 Participants | 8 Participants |
| Sex: Female, Male Male | 16 Participants | 11 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Qualitative Analysis of the Patient and Clinician Experience Using the Conversation Aid
The clinical visit and post visit semi-structure interviews of patient and clinicians that have used the conversation aid will be analyzed qualitatively to better understand the acceptability of the conversation aid in clinical practice and used to further update the conversation aid.
Time frame: Up to the time the post visit interview was completed (on average 1 weeks after the clinical visit for patients and 1 month after completion of 3 visit using the tool for clinicians)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients Receiving Care With the Conversation Aid | Qualitative Analysis of the Patient and Clinician Experience Using the Conversation Aid | Positive (tool features and components) | 12 Participants |
| Patients Receiving Care With the Conversation Aid | Qualitative Analysis of the Patient and Clinician Experience Using the Conversation Aid | Positive (Understanding the medical condition, situation and options) | 12 Participants |
| Patients Receiving Care With the Conversation Aid | Qualitative Analysis of the Patient and Clinician Experience Using the Conversation Aid | Positive (Interaction with the clinician) | 12 Participants |
| Patients Receiving Care With the Conversation Aid | Qualitative Analysis of the Patient and Clinician Experience Using the Conversation Aid | Negative (Suggestions for improvement related to TNOC features/components) | 7 Participants |
| Patients Receiving Care With the Conversation Aid | Qualitative Analysis of the Patient and Clinician Experience Using the Conversation Aid | Negative (Impact on the interaction) | 6 Participants |
| Patients Receiving Care With the Conversation Aid | Qualitative Analysis of the Patient and Clinician Experience Using the Conversation Aid | Positive (tool features) | 0 Participants |
| Patients Receiving Care With the Conversation Aid | Qualitative Analysis of the Patient and Clinician Experience Using the Conversation Aid | Positive (benefits patients) | 0 Participants |
| Patients Receiving Care With the Conversation Aid | Qualitative Analysis of the Patient and Clinician Experience Using the Conversation Aid | Positive (benefits clinicians) | 0 Participants |
| Patients Receiving Care With the Conversation Aid | Qualitative Analysis of the Patient and Clinician Experience Using the Conversation Aid | Negative (using TNOC is a change in their routine) | 0 Participants |
| Patients Receiving Care With the Conversation Aid | Qualitative Analysis of the Patient and Clinician Experience Using the Conversation Aid | Negative (Improvements to support the use of TNOC in routine Practice) | 0 Participants |
| Clinician Providing Care With the Conversation Aid | Qualitative Analysis of the Patient and Clinician Experience Using the Conversation Aid | Negative (Improvements to support the use of TNOC in routine Practice) | 1 Participants |
| Clinician Providing Care With the Conversation Aid | Qualitative Analysis of the Patient and Clinician Experience Using the Conversation Aid | Positive (tool features and components) | 0 Participants |
| Clinician Providing Care With the Conversation Aid | Qualitative Analysis of the Patient and Clinician Experience Using the Conversation Aid | Positive (tool features) | 4 Participants |
| Clinician Providing Care With the Conversation Aid | Qualitative Analysis of the Patient and Clinician Experience Using the Conversation Aid | Positive (Understanding the medical condition, situation and options) | 0 Participants |
| Clinician Providing Care With the Conversation Aid | Qualitative Analysis of the Patient and Clinician Experience Using the Conversation Aid | Negative (using TNOC is a change in their routine) | 1 Participants |
| Clinician Providing Care With the Conversation Aid | Qualitative Analysis of the Patient and Clinician Experience Using the Conversation Aid | Positive (Interaction with the clinician) | 0 Participants |
| Clinician Providing Care With the Conversation Aid | Qualitative Analysis of the Patient and Clinician Experience Using the Conversation Aid | Positive (benefits patients) | 4 Participants |
| Clinician Providing Care With the Conversation Aid | Qualitative Analysis of the Patient and Clinician Experience Using the Conversation Aid | Negative (Suggestions for improvement related to TNOC features/components) | 0 Participants |
| Clinician Providing Care With the Conversation Aid | Qualitative Analysis of the Patient and Clinician Experience Using the Conversation Aid | Positive (benefits clinicians) | 2 Participants |
| Clinician Providing Care With the Conversation Aid | Qualitative Analysis of the Patient and Clinician Experience Using the Conversation Aid | Negative (Impact on the interaction) | 0 Participants |