Trial Outcomes & Findings for PCORI-CER-1306-03385 Informed Decisions About Lung Cancer Screening (NCT NCT02286713)
NCT ID: NCT02286713
Last Updated: 2021-02-01
Results Overview
The Preparation for Decision Making© Scale assesses a patient's perception of how useful a decision aid or other decision support intervention is in preparing the respondent to communicate with their practitioner at a consultation visit and making a health decision. The scale is scored by summing the 10 items and dividing by 10. Scores are then converted to a 0-100 scale by subtracting 1 and multiplying by 25. Higher scores indicate higher perceived level of preparation for decision making. For this study, researchers used the patient version of the Preparation for Decision Making© scale, adapted for Lung Cancer Screening (LCS) context.
COMPLETED
NA
516 participants
Assessment at 1-week follow-up.
2021-02-01
Participant Flow
Recruitment Period: March 2015 to September 2016 from tobacco quitline new and former callers.
After consent participants completed baseline assessments prior to randomization.
Participant milestones
| Measure |
Patient Decision Aid
Decision Aid study materials including video mailed to participant with 1-week, 3-month, and 6-month follow-up assessments
|
Standard Educational Information
Study materials including education booklet mailed to participant with 1-week, 3-month, and 6-month follow-up assessments
|
|---|---|---|
|
One Week Follow-Up
STARTED
|
259
|
257
|
|
One Week Follow-Up
COMPLETED
|
235
|
233
|
|
One Week Follow-Up
NOT COMPLETED
|
24
|
24
|
|
Three Month Follow-Up
STARTED
|
252
|
254
|
|
Three Month Follow-Up
COMPLETED
|
224
|
228
|
|
Three Month Follow-Up
NOT COMPLETED
|
28
|
26
|
|
Six Month Follow-Up
STARTED
|
250
|
252
|
|
Six Month Follow-Up
COMPLETED
|
218
|
225
|
|
Six Month Follow-Up
NOT COMPLETED
|
32
|
27
|
Reasons for withdrawal
| Measure |
Patient Decision Aid
Decision Aid study materials including video mailed to participant with 1-week, 3-month, and 6-month follow-up assessments
|
Standard Educational Information
Study materials including education booklet mailed to participant with 1-week, 3-month, and 6-month follow-up assessments
|
|---|---|---|
|
One Week Follow-Up
Death
|
1
|
0
|
|
One Week Follow-Up
Lost to Follow-up
|
17
|
21
|
|
One Week Follow-Up
Withdrawal by Subject
|
6
|
3
|
|
Three Month Follow-Up
Death
|
1
|
1
|
|
Three Month Follow-Up
Lost to Follow-up
|
26
|
24
|
|
Three Month Follow-Up
Withdrawal by Subject
|
1
|
1
|
|
Six Month Follow-Up
Death
|
2
|
0
|
|
Six Month Follow-Up
Lost to Follow-up
|
30
|
27
|
Baseline Characteristics
PCORI-CER-1306-03385 Informed Decisions About Lung Cancer Screening
Baseline characteristics by cohort
| Measure |
Patient Decision Aid
n=259 Participants
Decision Aid study materials including video mailed to participant with 1-week, 3-month, and 6-month follow-up assessments
|
Standard Educational Information
n=257 Participants
Study materials including education booklet mailed to participant with 1-week, 3-month, and 6-month follow-up assessments
|
Total
n=516 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
190 Participants
n=5 Participants
|
180 Participants
n=7 Participants
|
370 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
69 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Age, Continuous
|
61.5 years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
61.7 years
STANDARD_DEVIATION 5.8 • n=7 Participants
|
61.6 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
157 Participants
n=5 Participants
|
163 Participants
n=7 Participants
|
320 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
102 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
196 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
62 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
185 Participants
n=5 Participants
|
177 Participants
n=7 Participants
|
362 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Refused
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
259 participants
n=5 Participants
|
257 participants
n=7 Participants
|
516 participants
n=5 Participants
|
|
Participant Pack-Year Smoking History
|
47.0 pack-years
n=5 Participants
|
49.0 pack-years
n=7 Participants
|
48.0 pack-years
n=5 Participants
|
|
Participant Education Level
Less than High School
|
41 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Participant Education Level
Graduated high school/GED
|
72 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
|
Participant Education Level
Some college/Trade school
|
107 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
212 Participants
n=5 Participants
|
|
Participant Education Level
Graduated college or more
|
39 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Participant Health Insurance Status
Has insurance
|
239 Participants
n=5 Participants
|
230 Participants
n=7 Participants
|
469 Participants
n=5 Participants
|
|
Participant Health Insurance Status
Does not have insurance
|
20 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessment at 1-week follow-up.Population: Of participants providing data at the 1-week follow-up, seventeen(17) of the participants did not answer the scale items and were therefore dropped from analysis.
The Preparation for Decision Making© Scale assesses a patient's perception of how useful a decision aid or other decision support intervention is in preparing the respondent to communicate with their practitioner at a consultation visit and making a health decision. The scale is scored by summing the 10 items and dividing by 10. Scores are then converted to a 0-100 scale by subtracting 1 and multiplying by 25. Higher scores indicate higher perceived level of preparation for decision making. For this study, researchers used the patient version of the Preparation for Decision Making© scale, adapted for Lung Cancer Screening (LCS) context.
Outcome measures
| Measure |
Patient Decision Aid
n=227 Participants
Decision Aid study materials including video mailed to participant with 1-week, 3-month, and 6-month follow-up assessments
|
Standard Educational Information
n=224 Participants
Study materials including education booklet mailed to participant with 1-week, 3-month, and 6-month follow-up assessments
|
|---|---|---|
|
Mean Value: Preparation for Decision Making© Scale
|
79.4 units on a scale
Standard Deviation 17.7
|
69.4 units on a scale
Standard Deviation 22.7
|
PRIMARY outcome
Timeframe: Assessment at 1-week follow-up.Population: All participants providing data at the 1-week follow-up where one participant in the Decision Aid Arm did not answer the scale questions and was dropped from the analysis.
A 3-item subscale that measures the degree to which the patient feels informed in making a decision about lung cancer screening. Total scores range from 0 (feels extremely informed) to 100 (feels extremely uninformed) related to making a decision. The scale was adapted for the LCS context.
Outcome measures
| Measure |
Patient Decision Aid
n=234 Participants
Decision Aid study materials including video mailed to participant with 1-week, 3-month, and 6-month follow-up assessments
|
Standard Educational Information
n=233 Participants
Study materials including education booklet mailed to participant with 1-week, 3-month, and 6-month follow-up assessments
|
|---|---|---|
|
Mean Value: Informed Subscale of the Decisional Conflict Scale©
|
27.1 units on a scale
Standard Deviation 25.9
|
42.1 units on a scale
Standard Deviation 30.8
|
PRIMARY outcome
Timeframe: Assessment at 1-week follow-up.Population: Of participants providing data at the 1-week follow-up, one participant in the Standard Educational Information group did not answer the Values Clarity Subscale questions and was dropped from the analysis and where one participant in the Decision Aid Arm did not answer the scale questions and was dropped from the analysis.
A 3-item subscale that measures the degree to which the patient feels clear about his or her values related to the lung cancer screening decision, including values about the harms and benefits. Total scores range from 0 (feels extremely clear about personal value for benefits and risks/side effects of screening) 100 (feels extremely unclear about personal value for benefits and risks/side effects of screening) related to making a decision. The scale was adapted for the LCS context.
Outcome measures
| Measure |
Patient Decision Aid
n=234 Participants
Decision Aid study materials including video mailed to participant with 1-week, 3-month, and 6-month follow-up assessments
|
Standard Educational Information
n=232 Participants
Study materials including education booklet mailed to participant with 1-week, 3-month, and 6-month follow-up assessments
|
|---|---|---|
|
Mean Value: Values Clarity Subscale of the Decisional Conflict Scale©
|
17.6 units on a scale
Standard Deviation 26.2
|
31.7 units on a scale
Standard Deviation 32.8
|
SECONDARY outcome
Timeframe: One week to 6 months, assessments at 1-week, 3-months and 6-months follow-up.Population: For the participants providing data at the 1-week follow-up, no data was missing in either group.
A 12-item, self-report measure of the patient's knowledge of facts related to lung cancer and lung cancer screening, including the harms and benefits of testing. The knowledge scale yields a single score, representing the percentage of correct responses (ranging from 0% to 100% correct). Higher scores indicate greater knowledge.
Outcome measures
| Measure |
Patient Decision Aid
n=235 Participants
Decision Aid study materials including video mailed to participant with 1-week, 3-month, and 6-month follow-up assessments
|
Standard Educational Information
n=233 Participants
Study materials including education booklet mailed to participant with 1-week, 3-month, and 6-month follow-up assessments
|
|---|---|---|
|
Mean Value: Knowledge of Lung Cancer Screening
6-Months
|
49.9 percentage of correct responses
Standard Deviation 17.8
|
40.0 percentage of correct responses
Standard Deviation 18.1
|
|
Mean Value: Knowledge of Lung Cancer Screening
One-week
|
57.5 percentage of correct responses
Standard Deviation 21.8
|
40.1 percentage of correct responses
Standard Deviation 17.1
|
|
Mean Value: Knowledge of Lung Cancer Screening
3-Months
|
44.4 percentage of correct responses
Standard Deviation 19.6
|
35.9 percentage of correct responses
Standard Deviation 16.9
|
Adverse Events
Patient Decision Aid
Standard Educational Information
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Clinical Research Operations Team, Office of VP Clinical Research
UT MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place