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. The study aims to update a conversation aid prototype that was developed to support shared decision making in the diagnosis of thyroid cancer and conduct a pilot clinical trial to evaluate the feasibility of conducting a larger efficacy study.
Interventions
Patients receive counseling about thyroid biopsy with the use of the conversation aid.
BEHAVIORALcounseling by routine care
Patients receive counseling by routine care without the use of the conversation aid
Sponsors
National Cancer Institute (NCI)
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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 |
|---|---|---|
| Proportion of Eligible Patients for Feasibility | at 6 months of follow up | Proportion of participants that are eligible relative to total trial referrals.To measure the proportion of eligible patients after review of upcoming clinical visits, enrollment and refusal reasons, ability to randomize patients and tolerability by patients and clinicians of the required assessments (time to complete assessments and obtain complete assessment at 6 months of follow up). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adequate Randomization | initial clinical visit | Proportion of patients that were randomized and completed the study |
| Completeness of Baseline Survey (Patients) | baseline | Proportion of patients that completed the baseline survey |
| Patient Survey (6 Months) | 6 months | Proportion of patients that completed the 6 month survey |
| Clinician Baseline Survey | baseline | — |
| Knowledge | baseline | To assess knowledge transfer related to thyroid nodules, patients completed a 12-item questionnaire with Yes/No and I don't know response options, related to thyroid nodule knowledge. Higher score indicate increased number of correct answers. |
| Decisional Conflict | baseline | Decisional conflicts reflects degree of conflict with the decision made. This construct was evaluated with a validated questionnaire that includes 16-items, with the total score transformed into a 1-100 scale, with higher scores indicating greater decisional conflict. |
| OPTION Score | baseline | Observing Patient Involvement (OPTION), evaluates the extent to which clinicians engaged patients in decision making, higher levels more engagement, range (0-100) |
| Patient's Acceptance to Participate in the Study | first visit | From eligible patients that were invited to participate, the proportion of patients that agreed to enter the study |
| Diagnostic Decision | baseline | Proportion of patients undergoing thyroid biopsy |
| Fidelity | baseline | Fidelity of use of the conversation aid during clinical visit, evaluating using 12 items during review of clinical visit. Higher percentage refers to higher number of items observed. |
| Risk Communication | baseline | Proportion of visits in which thyroid cancer risk was communicated evaluated through review of clinical visit, as yes/no outcome. |
| Satisfaction With the Communication (Patient) | baseline | Likert score, lower number more satisfied, 1-7 |
| Satisfaction With the Visit (Clinician) | baseline | Likert score, higher numbers better, 1-5 options |
| Worry About Thyroid Cancer | baseline | Worry about thyroid cancer diagnosis assessed through a survey item, including the options Not at all, rarely/a little or somewhat or a lot |
| Distress Due to Thyroid Nodule (6 Months) | 6 months | Impact of Event Scale evaluates distress with a new medical situation (new thyroid nodule in this case). The scale includes 6 items, with a score range from 0 to 24 points, with higher values indicating more distress. |
| Visit Duration | baseline | Length of the clinical visit |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients - Intervention Group Counseling using the electronic conversation aid
Counseling using the electronic conversation aid: Patients receive counseling about thyroid biopsy with the use of the conversation aid. | 43 |
| Patients - Control Group Routine counseling only
counseling by routine care: Patients receive counseling by routine care without the use of the conversation aid | 43 |
| Clinicians Clinicians enrolled in the study counseled patients with or without the use of the conversation aid, per patient randomization assignment | 17 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Exclusion criteria identified during clinical visit | 2 | 2 | 0 |
Baseline characteristics
| Characteristic | Patients - Control Group | Total | Patients - Intervention Group | Clinicians |
|---|---|---|---|---|
| Age, Continuous | 57.2 years STANDARD_DEVIATION 15.5 | 57.2 years STANDARD_DEVIATION 15.8 | 57.1 years STANDARD_DEVIATION 16.2 | — |
| Education Graduate or professional degree | 19 Participants | 41 Participants | 22 Participants | — |
| Education High school graduate | 4 Participants | 8 Participants | 4 Participants | — |
| Education Less than high school | 0 Participants | 1 Participants | 1 Participants | — |
| Education Missing | 3 Participants | 4 Participants | 1 Participants | — |
| Education Professional degree in health related sciences | 6 Participants | 11 Participants | 5 Participants | — |
| Education Some college, no degree | 11 Participants | 21 Participants | 10 Participants | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants | — |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 43 Participants | 84 Participants | 41 Participants | — |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | — |
| General Health Excellent/Very good | 10 Participants | 30 Participants | 20 Participants | — |
| General Health Fair | 9 Participants | 14 Participants | 5 Participants | — |
| General Health Good | 21 Participants | 36 Participants | 15 Participants | — |
| General Health Missing | 2 Participants | 2 Participants | 0 Participants | — |
| General Health Poor | 1 Participants | 4 Participants | 3 Participants | — |
| Income >$150,000 | 6 Participants | 13 Participants | 7 Participants | — |
| Income < $40,000 | 13 Participants | 27 Participants | 14 Participants | — |
| Income $40,000 to $79,999 | 10 Participants | 19 Participants | 9 Participants | — |
| Income $80,000 to $149,999 | 11 Participants | 22 Participants | 11 Participants | — |
| Income Missing | 3 Participants | 5 Participants | 2 Participants | — |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants | — |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants | — |
| Race (NIH/OMB) Black or African American | 5 Participants | 7 Participants | 2 Participants | — |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants | — |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | — |
| Race (NIH/OMB) White | 37 Participants | 74 Participants | 37 Participants | — |
| Region of Enrollment United States | 43 participants | 86 participants | 43 participants | 17 participants |
| Sex: Female, Male Female | 33 Participants | 69 Participants | 36 Participants | — |
| Sex: Female, Male Male | 10 Participants | 17 Participants | 7 Participants | — |
| Thyroid nodule size | 1.8 cm | 1.7 cm | 1.6 cm | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 43 | 0 / 43 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Proportion of Eligible Patients for Feasibility
Proportion of participants that are eligible relative to total trial referrals.To measure the proportion of eligible patients after review of upcoming clinical visits, enrollment and refusal reasons, ability to randomize patients and tolerability by patients and clinicians of the required assessments (time to complete assessments and obtain complete assessment at 6 months of follow up).
Time frame: at 6 months of follow up
Population: Number of patients that were screened for inclusion in the study
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Eligible Patient for the Study | Proportion of Eligible Patients for Feasibility | Eligible Patients Based on Chart Review | 213 Participants |
| Eligible Patient for the Study | Proportion of Eligible Patients for Feasibility | Patients not eligible based on chart review | 318 Participants |
Secondary
Adequate Randomization
Proportion of patients that were randomized and completed the study
Time frame: initial clinical visit
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Eligible Patient for the Study | Adequate Randomization | Adequate randomization | 86 Participants |
| Eligible Patient for the Study | Adequate Randomization | Post Randomization exclusion | 4 Participants |
Secondary
Clinician Baseline Survey
Time frame: baseline
Population: 17 clinicians care for the patients in the study and were asked to complete a baseline survey
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Eligible Patient for the Study | Clinician Baseline Survey | Completed | 17 Participants |
| Eligible Patient for the Study | Clinician Baseline Survey | Not Completed | 0 Participants |
Secondary
Completeness of Baseline Survey (Patients)
Proportion of patients that completed the baseline survey
Time frame: baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Eligible Patient for the Study | Completeness of Baseline Survey (Patients) | Completed baseline survey | 84 Participants |
| Eligible Patient for the Study | Completeness of Baseline Survey (Patients) | Did not complete baseline survey | 2 Participants |
Secondary
Decisional Conflict
Decisional conflicts reflects degree of conflict with the decision made. This construct was evaluated with a validated questionnaire that includes 16-items, with the total score transformed into a 1-100 scale, with higher scores indicating greater decisional conflict.
Time frame: baseline
Population: 43 were randomized in each arm in the study, and for 31 in the intervention group items related the decisional conflict scale in the survey were completed and 23 for those in the control group.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Eligible Patient for the Study | Decisional Conflict | 10.9 score on a scale |
| Control Group | Decisional Conflict | 20.3 score on a scale |
Secondary
Diagnostic Decision
Proportion of patients undergoing thyroid biopsy
Time frame: baseline
Population: 43 patients were randomized in the study, the outcome of next diagnostic test (undergoing thyroid biopsy) was assessed from clinical chart review which was available for all patients.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Eligible Patient for the Study | Diagnostic Decision | Thyroid Biopsy | 17 Participants |
| Eligible Patient for the Study | Diagnostic Decision | Other | 26 Participants |
| Control Group | Diagnostic Decision | Thyroid Biopsy | 22 Participants |
| Control Group | Diagnostic Decision | Other | 21 Participants |
Secondary
Distress Due to Thyroid Nodule (6 Months)
Impact of Event Scale evaluates distress with a new medical situation (new thyroid nodule in this case). The scale includes 6 items, with a score range from 0 to 24 points, with higher values indicating more distress.
Time frame: 6 months
Population: From the initial population of 86 participants (43 in each group), 6 were diagnosed with thyroid cancer and were not eligible for evaluation of outcomes at 6 months of follow up. Leaving 42 eligible patients in the intervention group (1 cancer diagnosis) of which 29 completed the follow up survey and 38 in the control group (5 cancer diagnoses) of which 21 completed the follow up survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eligible Patient for the Study | Distress Due to Thyroid Nodule (6 Months) | 1.1 units on a scale | Standard Deviation 2.1 |
| Control Group | Distress Due to Thyroid Nodule (6 Months) | 3.0 units on a scale | Standard Deviation 3.1 |
Secondary
Fidelity
Fidelity of use of the conversation aid during clinical visit, evaluating using 12 items during review of clinical visit. Higher percentage refers to higher number of items observed.
Time frame: baseline
Population: 43 patients were randomized in the study, and clinical visit recordings were available for 42 patients in the intervention group and 43 patients in the control group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eligible Patient for the Study | Fidelity | 78.6 percentage of items of the conversation | Standard Error 16.5 |
| Control Group | Fidelity | 59.6 percentage of items of the conversation | Standard Error 17.9 |
Secondary
Knowledge
To assess knowledge transfer related to thyroid nodules, patients completed a 12-item questionnaire with Yes/No and I don't know response options, related to thyroid nodule knowledge. Higher score indicate increased number of correct answers.
Time frame: baseline
Population: 43 patients were included in each arm, completion of survey items related to knowledge were available for 40 patients in the intervention group and 41 patients in the control group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eligible Patient for the Study | Knowledge | 72.1 correct response | Standard Deviation 18.1 |
| Control Group | Knowledge | 65.0 correct response | Standard Deviation 22.4 |
Secondary
OPTION Score
Observing Patient Involvement (OPTION), evaluates the extent to which clinicians engaged patients in decision making, higher levels more engagement, range (0-100)
Time frame: baseline
Population: 43 patients were randomized in the study, and clinical visit recordings were available for 42 patients in the intervention group and 43 patients in the control group.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Eligible Patient for the Study | OPTION Score | 35.4 score on a scale |
| Control Group | OPTION Score | 27.1 score on a scale |
Secondary
Patient's Acceptance to Participate in the Study
From eligible patients that were invited to participate, the proportion of patients that agreed to enter the study
Time frame: first visit
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Eligible Patient for the Study | Patient's Acceptance to Participate in the Study | Patients that agree to participate | 90 Participants |
| Eligible Patient for the Study | Patient's Acceptance to Participate in the Study | Patients that refused participation | 30 Participants |
Secondary
Patient Survey (6 Months)
Proportion of patients that completed the 6 month survey
Time frame: 6 months
Population: From the initial group of 86 patients, 6 were diagnosed with cancer and not eligible for the follow up survey.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Eligible Patient for the Study | Patient Survey (6 Months) | Completed the survey | 50 Participants |
| Eligible Patient for the Study | Patient Survey (6 Months) | Did not complete the survey | 30 Participants |
Secondary
Risk Communication
Proportion of visits in which thyroid cancer risk was communicated evaluated through review of clinical visit, as yes/no outcome.
Time frame: baseline
Population: 43 patients were randomized in the study, and clinical visit recordings were available for 42 patients in the intervention group and 43 patients in the control group.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Eligible Patient for the Study | Risk Communication | Risk communicated yes | 39 Participants |
| Eligible Patient for the Study | Risk Communication | Risk communicated no | 3 Participants |
| Control Group | Risk Communication | Risk communicated no | 5 Participants |
| Control Group | Risk Communication | Risk communicated yes | 38 Participants |
Secondary
Satisfaction With the Communication (Patient)
Likert score, lower number more satisfied, 1-7
Time frame: baseline
Population: 43 patients were randomized in each arm, for all patients in the intervention group items related to satisfaction were completed in the survey and for 41 in the control group these items were completed in the survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eligible Patient for the Study | Satisfaction With the Communication (Patient) | 1.3 units on a scale | Standard Deviation 0.8 |
| Control Group | Satisfaction With the Communication (Patient) | 1.4 units on a scale | Standard Deviation 0.9 |
Secondary
Satisfaction With the Visit (Clinician)
Likert score, higher numbers better, 1-5 options
Time frame: baseline
Population: Clinicians expressed satisfaction with the clinical visit through a survey, that was completed for all patients in the intervention group (43) and (42) in the control group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eligible Patient for the Study | Satisfaction With the Visit (Clinician) | 4.5 units on a scale | Standard Deviation 0.7 |
| Control Group | Satisfaction With the Visit (Clinician) | 4.4 units on a scale | Standard Deviation 0.7 |
Secondary
Visit Duration
Length of the clinical visit
Time frame: baseline
Population: 43 patients were randomized in the study, and clinical visit recordings were available for 42 patients in the intervention group and 43 patients in the control group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eligible Patient for the Study | Visit Duration | 21.5 minutes | Standard Deviation 9.3 |
| Control Group | Visit Duration | 22.1 minutes | Standard Deviation 9.3 |
Secondary
Worry About Thyroid Cancer
Worry about thyroid cancer diagnosis assessed through a survey item, including the options Not at all, rarely/a little or somewhat or a lot
Time frame: baseline
Population: 43 patients were randomized in each arm, survey responses for this outcome were available for 43 participants in the intervention group and 41 participants in the control group.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Eligible Patient for the Study | Worry About Thyroid Cancer | Not at all | 14 Participants |
| Eligible Patient for the Study | Worry About Thyroid Cancer | Rarely/ a litte | 16 Participants |
| Eligible Patient for the Study | Worry About Thyroid Cancer | Somewhat or a lot | 13 Participants |
| Control Group | Worry About Thyroid Cancer | Not at all | 8 Participants |
| Control Group | Worry About Thyroid Cancer | Rarely/ a litte | 18 Participants |
| Control Group | Worry About Thyroid Cancer | Somewhat or a lot | 15 Participants |