Trial Outcomes & Findings for Incorporating Veterans' Preferences Into Lung Cancer Screening Decisions (NCT NCT02899754)
NCT ID: NCT02899754
Last Updated: 2024-11-14
Results Overview
The Decisional Conflict Scale is a 16-item scale with a value that ranges 0 (low decisional conflict) to 100 (high decisional conflict. The scale includes five subscales in the domains of uncertainty ( 3 items), Informed (3 items), Value Clarity (3 items), Support ( 3 items), and Effective DM (4 items). Each item is scored from a 0 (strongly agree), 1 (agree), 2 (neither agree nor disagree), 3) (disagree) or 4 (strongly disagree). The total sore for the 16 items is calculated by a) summing scores, b) dividing by 16, c) multiplying by 25. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict). For each subscale the scores are obtained by a) summing scores, b) dividing by the number of items in the subscale, c) multiplying by 25. Scores are interpreted as range from 0(low decisional conflict) to 100 (high decisional conflict) in the respective domains.
COMPLETED
NA
140 participants
1 month following the intervention
2024-11-14
Participant Flow
Participant milestones
| Measure |
Intervention Group
Participants in this arm will use the lung cancer screening decision aid (LCSDecTool)
Lung Cancer Screening Decision Tool: This will be a lung cancer screening decision support tool that is web based and provides patients with information about the potential benefits and harms associated with lung cancer screening and helps them to consider their personal values when making a decision about whether to initiate or continue with lung cancer screening.
|
Control Group
Content that provides general information on disease prevention and health promotion unrelated to lung cancer. The information will be delivered on the same modality and take a similar amount of time to administer.
Control Intervention: This will be a health message regarding prevention and healthy behavior that is not related to lung cancer screening but delivered in a similar modality and taking approximately the same amount of time as the LCSDecTool.
|
|---|---|---|
|
Overall Study
STARTED
|
69
|
71
|
|
Overall Study
COMPLETED
|
62
|
62
|
|
Overall Study
NOT COMPLETED
|
7
|
9
|
Reasons for withdrawal
| Measure |
Intervention Group
Participants in this arm will use the lung cancer screening decision aid (LCSDecTool)
Lung Cancer Screening Decision Tool: This will be a lung cancer screening decision support tool that is web based and provides patients with information about the potential benefits and harms associated with lung cancer screening and helps them to consider their personal values when making a decision about whether to initiate or continue with lung cancer screening.
|
Control Group
Content that provides general information on disease prevention and health promotion unrelated to lung cancer. The information will be delivered on the same modality and take a similar amount of time to administer.
Control Intervention: This will be a health message regarding prevention and healthy behavior that is not related to lung cancer screening but delivered in a similar modality and taking approximately the same amount of time as the LCSDecTool.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
9
|
Baseline Characteristics
Incorporating Veterans' Preferences Into Lung Cancer Screening Decisions
Baseline characteristics by cohort
| Measure |
Intervention Group
n=69 Participants
Participants in this arm will use the lung cancer screening decision aid (LCSDecTool)
Lung Cancer Screening Decision Tool: This will be a lung cancer screening decision support tool that is web based and provides patients with information about the potential benefits and harms associated with lung cancer screening and helps them to consider their personal values when making a decision about whether to initiate or continue with lung cancer screening.
|
Control Group
n=71 Participants
Content that provides general information on disease prevention and health promotion unrelated to lung cancer. The information will be delivered on the same modality and take a similar amount of time to administer.
Control Intervention: This will be a health message regarding prevention and healthy behavior that is not related to lung cancer screening but delivered in a similar modality and taking approximately the same amount of time as the LCSDecTool.
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
65.0 years
n=7 Participants
|
64.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
68 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
42 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
69 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Education
Grade School
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Education
High School
|
28 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Education
Some College or University
|
33 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Education
Four or more years of college or university
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Education
Post-college graduate degree
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Income
0-25,000
|
28 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Income
>25,000 - 50.000
|
24 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Income
>50.000 - 75,000
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Income
>75.000 - 100.000
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Income
>100.000
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Income
Prefer not to say
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Post Traumatic Stress Syndrome
Post-Traumatic Stress Syndrome Yes
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Post Traumatic Stress Syndrome
Post-Traumatic Stress Syndrome No
|
38 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Depression
Depression Yes
|
33 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Depression
Depression No
|
36 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Anxiety
Anxiety Yes
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Anxiety
Anxiety No
|
45 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Hypertension
Hypertension Yes
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Hypertension
Hypertension No
|
44 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Diabetes
Diabetes Yes
|
18 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Diabetes
Diabetes No
|
51 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Emphysema
Emphysema Yes
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Emphysema
Emphysema No
|
55 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Heart Disease
Heart Disease Yes
|
9 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Heart Disease
Heart Disease No
|
60 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Asthma
Asthma Yes
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Asthma
Asthma No
|
65 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Health Literacy
|
66.0 units on a scale
n=5 Participants
|
66.0 units on a scale
n=7 Participants
|
66.0 units on a scale
n=5 Participants
|
|
Numeracy
|
4.0 units on a scale
n=5 Participants
|
5.0 units on a scale
n=7 Participants
|
5.0 units on a scale
n=5 Participants
|
|
Arthritis
Arthritis Yes
|
30 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Arthritis
Arthritis No
|
39 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Smoking Pack Years
|
40.8 Pack Years of Smoking
n=5 Participants
|
46.0 Pack Years of Smoking
n=7 Participants
|
44.2 Pack Years of Smoking
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 month following the interventionPopulation: There were 7 participants that were lost to follow-up at the 1 month visit in the experimental group and 9 participants that were lost to follow up at the 1 month visit in the control group.
The Decisional Conflict Scale is a 16-item scale with a value that ranges 0 (low decisional conflict) to 100 (high decisional conflict. The scale includes five subscales in the domains of uncertainty ( 3 items), Informed (3 items), Value Clarity (3 items), Support ( 3 items), and Effective DM (4 items). Each item is scored from a 0 (strongly agree), 1 (agree), 2 (neither agree nor disagree), 3) (disagree) or 4 (strongly disagree). The total sore for the 16 items is calculated by a) summing scores, b) dividing by 16, c) multiplying by 25. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict). For each subscale the scores are obtained by a) summing scores, b) dividing by the number of items in the subscale, c) multiplying by 25. Scores are interpreted as range from 0(low decisional conflict) to 100 (high decisional conflict) in the respective domains.
Outcome measures
| Measure |
Intervention Group
n=62 Participants
Participants in this arm will use the lung cancer screening decision aid (LCSDecTool)
Lung Cancer Screening Decision Tool: This will be a lung cancer screening decision support tool that is web based and provides patients with information about the potential benefits and harms associated with lung cancer screening and helps them to consider their personal values when making a decision about whether to initiate or continue with lung cancer screening.
|
Control Group
n=62 Participants
Content that provides general information on disease prevention and health promotion unrelated to lung cancer. The information will be delivered on the same modality and take a similar amount of time to administer.
Control Intervention: This will be a health message regarding prevention and healthy behavior that is not related to lung cancer screening but delivered in a similar modality and taking approximately the same amount of time as the LCSDecTool.
|
|---|---|---|
|
Decisional Conflict
|
25.7 units on a scale
Interval 21.4 to 30.1
|
29.9 units on a scale
Interval 25.6 to 34.2
|
SECONDARY outcome
Timeframe: 1 month following interventionPopulation: There were 7 participants that were lost to follow-up at the 1 month follow-up visit in experimental intervention group and 9 participants in the control group that were lost to follow up at the 1 month follow-up visit
Decision regret as measured by a 5-item Decision Regret scale that is patient reported. This score range is from 0 (low decisional regret) to 100 (high decisional regret).
Outcome measures
| Measure |
Intervention Group
n=62 Participants
Participants in this arm will use the lung cancer screening decision aid (LCSDecTool)
Lung Cancer Screening Decision Tool: This will be a lung cancer screening decision support tool that is web based and provides patients with information about the potential benefits and harms associated with lung cancer screening and helps them to consider their personal values when making a decision about whether to initiate or continue with lung cancer screening.
|
Control Group
n=62 Participants
Content that provides general information on disease prevention and health promotion unrelated to lung cancer. The information will be delivered on the same modality and take a similar amount of time to administer.
Control Intervention: This will be a health message regarding prevention and healthy behavior that is not related to lung cancer screening but delivered in a similar modality and taking approximately the same amount of time as the LCSDecTool.
|
|---|---|---|
|
Decision Regret
|
34.7 units on a scale
Interval 32.2 to 37.2
|
32.2 units on a scale
Interval 29.6 to 34.8
|
SECONDARY outcome
Timeframe: Immediately Post Intervention, within 24 hours of intervention following the interventionKnowledge was measured with the 12-Item Brief Measures of Smokers Knowledge of Lung Cancer Screening Scale. The scores on this scale range from 0 (low level of knowledge) to 12 (high level of knowledge). Higher scores indicate a better outcome. Each correct response to an item is added to create the final score.
Outcome measures
| Measure |
Intervention Group
n=69 Participants
Participants in this arm will use the lung cancer screening decision aid (LCSDecTool)
Lung Cancer Screening Decision Tool: This will be a lung cancer screening decision support tool that is web based and provides patients with information about the potential benefits and harms associated with lung cancer screening and helps them to consider their personal values when making a decision about whether to initiate or continue with lung cancer screening.
|
Control Group
n=71 Participants
Content that provides general information on disease prevention and health promotion unrelated to lung cancer. The information will be delivered on the same modality and take a similar amount of time to administer.
Control Intervention: This will be a health message regarding prevention and healthy behavior that is not related to lung cancer screening but delivered in a similar modality and taking approximately the same amount of time as the LCSDecTool.
|
|---|---|---|
|
Lung Cancer Knowledge
|
7.0 units on a scale
Interval 6.3 to 7.7
|
4.9 units on a scale
Interval 4.3 to 5.5
|
SECONDARY outcome
Timeframe: 1 month post interventionPopulation: There were 7 participants that were lost to follow up at the time of the 1 month survey assessment for the experimental group and 9 participants lost to follow-up at the time of the 1 month survey assessment.in the control group.
Knowledge was measured with the 12-Item Brief Measures of Smokers Knowledge of Lung Cancer Screening Scale. The scores on this scale range from 0 (low level of knowledge) to 12 (high level of knowledge). Higher scores indicate a higher amount of knowledge. Higher scores are a better outcome. 1 point is given to each correct item. The points are added to provide the total score.
Outcome measures
| Measure |
Intervention Group
n=62 Participants
Participants in this arm will use the lung cancer screening decision aid (LCSDecTool)
Lung Cancer Screening Decision Tool: This will be a lung cancer screening decision support tool that is web based and provides patients with information about the potential benefits and harms associated with lung cancer screening and helps them to consider their personal values when making a decision about whether to initiate or continue with lung cancer screening.
|
Control Group
n=62 Participants
Content that provides general information on disease prevention and health promotion unrelated to lung cancer. The information will be delivered on the same modality and take a similar amount of time to administer.
Control Intervention: This will be a health message regarding prevention and healthy behavior that is not related to lung cancer screening but delivered in a similar modality and taking approximately the same amount of time as the LCSDecTool.
|
|---|---|---|
|
Lung Cancer Screening Knowledge
|
6.3 units on a scale
Interval 5.7 to 6.8
|
5.2 units on a scale
Interval 4.5 to 5.8
|
SECONDARY outcome
Timeframe: 3 months post interventionPopulation: There were 9 participants in the experimental group that were lost to follow-up at the time of the 3 month survey and 14 participants in the control group that were lost to follow-up at the time of the 3 month survey.
Knowledge was measured with the 12-Item Brief Measures of Smokers Knowledge of Lung Cancer Screening Scale. The scores on this scale range from 0 (low level of knowledge) to 12 (high level of knowledge).
Outcome measures
| Measure |
Intervention Group
n=60 Participants
Participants in this arm will use the lung cancer screening decision aid (LCSDecTool)
Lung Cancer Screening Decision Tool: This will be a lung cancer screening decision support tool that is web based and provides patients with information about the potential benefits and harms associated with lung cancer screening and helps them to consider their personal values when making a decision about whether to initiate or continue with lung cancer screening.
|
Control Group
n=57 Participants
Content that provides general information on disease prevention and health promotion unrelated to lung cancer. The information will be delivered on the same modality and take a similar amount of time to administer.
Control Intervention: This will be a health message regarding prevention and healthy behavior that is not related to lung cancer screening but delivered in a similar modality and taking approximately the same amount of time as the LCSDecTool.
|
|---|---|---|
|
Lung Cancer Screening Knowledge
|
6.2 units on a scale
Interval 5.6 to 6.8
|
5.1 units on a scale
Interval 4.4 to 5.8
|
SECONDARY outcome
Timeframe: 1 month following interventionPopulation: There were 7 participants in the experimental intervention group that were lost to follow up at the 1 month survey assessment and 9 participants in the control group that were lost to follow up at the 2 month survey assessment.
State anxiety was measured on the State Trait Anxiety Index Scale using the State subscale. This measure included 20 items with a total score ranging from 20 (low anxiety) to 80 (high anxiety).
Outcome measures
| Measure |
Intervention Group
n=62 Participants
Participants in this arm will use the lung cancer screening decision aid (LCSDecTool)
Lung Cancer Screening Decision Tool: This will be a lung cancer screening decision support tool that is web based and provides patients with information about the potential benefits and harms associated with lung cancer screening and helps them to consider their personal values when making a decision about whether to initiate or continue with lung cancer screening.
|
Control Group
n=62 Participants
Content that provides general information on disease prevention and health promotion unrelated to lung cancer. The information will be delivered on the same modality and take a similar amount of time to administer.
Control Intervention: This will be a health message regarding prevention and healthy behavior that is not related to lung cancer screening but delivered in a similar modality and taking approximately the same amount of time as the LCSDecTool.
|
|---|---|---|
|
Anxiety
|
37.2 units on a scale
Interval 34.0 to 40.4
|
35.2 units on a scale
Interval 31.3 to 39.0
|
SECONDARY outcome
Timeframe: 6 months after the interventionDocumentation of receiving a lung cancer screening test by 6 months following the intervention. This was obtained by chart review.
Outcome measures
| Measure |
Intervention Group
n=69 Participants
Participants in this arm will use the lung cancer screening decision aid (LCSDecTool)
Lung Cancer Screening Decision Tool: This will be a lung cancer screening decision support tool that is web based and provides patients with information about the potential benefits and harms associated with lung cancer screening and helps them to consider their personal values when making a decision about whether to initiate or continue with lung cancer screening.
|
Control Group
n=71 Participants
Content that provides general information on disease prevention and health promotion unrelated to lung cancer. The information will be delivered on the same modality and take a similar amount of time to administer.
Control Intervention: This will be a health message regarding prevention and healthy behavior that is not related to lung cancer screening but delivered in a similar modality and taking approximately the same amount of time as the LCSDecTool.
|
|---|---|---|
|
Lung Cancer Screening Uptake
|
26 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 9 monthsA documented lung cancer screening test completed within 9 months of the intervention obtained by chart review
Outcome measures
| Measure |
Intervention Group
n=69 Participants
Participants in this arm will use the lung cancer screening decision aid (LCSDecTool)
Lung Cancer Screening Decision Tool: This will be a lung cancer screening decision support tool that is web based and provides patients with information about the potential benefits and harms associated with lung cancer screening and helps them to consider their personal values when making a decision about whether to initiate or continue with lung cancer screening.
|
Control Group
n=71 Participants
Content that provides general information on disease prevention and health promotion unrelated to lung cancer. The information will be delivered on the same modality and take a similar amount of time to administer.
Control Intervention: This will be a health message regarding prevention and healthy behavior that is not related to lung cancer screening but delivered in a similar modality and taking approximately the same amount of time as the LCSDecTool.
|
|---|---|---|
|
Lung Cancer Screening Uptake Within 9 Months
|
31 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 1 month after the interventionPopulation: There were 7 participants in the experimental intervention group that were lost to follow-up at the 1 month survey and 9 participants in the control group that were lost to follow-up at the 1 month survey.
Lung cancer worry as measured by a 7 item scale with a range of scores from 3 (low worry) to 13 (high worry).
Outcome measures
| Measure |
Intervention Group
n=62 Participants
Participants in this arm will use the lung cancer screening decision aid (LCSDecTool)
Lung Cancer Screening Decision Tool: This will be a lung cancer screening decision support tool that is web based and provides patients with information about the potential benefits and harms associated with lung cancer screening and helps them to consider their personal values when making a decision about whether to initiate or continue with lung cancer screening.
|
Control Group
n=62 Participants
Content that provides general information on disease prevention and health promotion unrelated to lung cancer. The information will be delivered on the same modality and take a similar amount of time to administer.
Control Intervention: This will be a health message regarding prevention and healthy behavior that is not related to lung cancer screening but delivered in a similar modality and taking approximately the same amount of time as the LCSDecTool.
|
|---|---|---|
|
Lung Cancer Worry
|
6.3 units on a scale
Interval 5.7 to 6.8
|
6.3 units on a scale
Interval 5.7 to 7.0
|
SECONDARY outcome
Timeframe: Immediately post-intervention-the same day as the intervention following the intervention.Population: Two participants in the intervention group did not complete the immediately post-intervention survey and 2 participants in the control group did not complete the immediately post-intervention survey.
Measured by the Decisional Conflict Scale a 16-item scale with scores from 0(low decisional conflict) to 100 (high decisional conflict).
Outcome measures
| Measure |
Intervention Group
n=67 Participants
Participants in this arm will use the lung cancer screening decision aid (LCSDecTool)
Lung Cancer Screening Decision Tool: This will be a lung cancer screening decision support tool that is web based and provides patients with information about the potential benefits and harms associated with lung cancer screening and helps them to consider their personal values when making a decision about whether to initiate or continue with lung cancer screening.
|
Control Group
n=69 Participants
Content that provides general information on disease prevention and health promotion unrelated to lung cancer. The information will be delivered on the same modality and take a similar amount of time to administer.
Control Intervention: This will be a health message regarding prevention and healthy behavior that is not related to lung cancer screening but delivered in a similar modality and taking approximately the same amount of time as the LCSDecTool.
|
|---|---|---|
|
Decisional Conflict
|
22.2 units on a scale
Interval 18.3 to 26.0
|
31.1 units on a scale
Interval 26.1 to 36.0
|
SECONDARY outcome
Timeframe: 3 months post-interventionPopulation: There were 9 participants that were lost to follow-up at the 3 month survey assessment in the intervention group and 14 lost to follow-up at the 3 month assessment in the control group.
Decisional conflict as measured by the 16 item decisional conflict scale scored from 0 (low decisional conflict) to 100 (high decisional conflict)
Outcome measures
| Measure |
Intervention Group
n=60 Participants
Participants in this arm will use the lung cancer screening decision aid (LCSDecTool)
Lung Cancer Screening Decision Tool: This will be a lung cancer screening decision support tool that is web based and provides patients with information about the potential benefits and harms associated with lung cancer screening and helps them to consider their personal values when making a decision about whether to initiate or continue with lung cancer screening.
|
Control Group
n=57 Participants
Content that provides general information on disease prevention and health promotion unrelated to lung cancer. The information will be delivered on the same modality and take a similar amount of time to administer.
Control Intervention: This will be a health message regarding prevention and healthy behavior that is not related to lung cancer screening but delivered in a similar modality and taking approximately the same amount of time as the LCSDecTool.
|
|---|---|---|
|
Decisional Conflict
|
24.2 Scores on the decisional conflict scale
Interval 20.8 to 27.6
|
27.5 Scores on the decisional conflict scale
Interval 23.3 to 31.7
|
SECONDARY outcome
Timeframe: 3 months post-interventionPopulation: There were 9 participants lost to follow-up from the intervention group at the 3 month survey and 14 participants lost to follow-up in the intervention group at the 3 month survey
Decisional regret was measured on the Decisional Regret scale. This is a 5 time scale with scores ranging from 0 (low decisional regret) to 100 (high decisional regret).
Outcome measures
| Measure |
Intervention Group
n=60 Participants
Participants in this arm will use the lung cancer screening decision aid (LCSDecTool)
Lung Cancer Screening Decision Tool: This will be a lung cancer screening decision support tool that is web based and provides patients with information about the potential benefits and harms associated with lung cancer screening and helps them to consider their personal values when making a decision about whether to initiate or continue with lung cancer screening.
|
Control Group
n=57 Participants
Content that provides general information on disease prevention and health promotion unrelated to lung cancer. The information will be delivered on the same modality and take a similar amount of time to administer.
Control Intervention: This will be a health message regarding prevention and healthy behavior that is not related to lung cancer screening but delivered in a similar modality and taking approximately the same amount of time as the LCSDecTool.
|
|---|---|---|
|
Decisional Regret
|
32.5 units on a scale
Interval 30.1 to 35.0
|
34.3 units on a scale
Interval 31.9 to 36.7
|
SECONDARY outcome
Timeframe: Immediately post-intervention-the same day as the intervention following the interventionPopulation: There were 2 participants in the intervention group and 2 participants in the control group that did not complete the post-intervention survey when this outcome was ascertained.
Decisional regret was measured on a 5 point decisional regret scale with scores ranging from 0 (low regret) to 100 (high regret).
Outcome measures
| Measure |
Intervention Group
n=67 Participants
Participants in this arm will use the lung cancer screening decision aid (LCSDecTool)
Lung Cancer Screening Decision Tool: This will be a lung cancer screening decision support tool that is web based and provides patients with information about the potential benefits and harms associated with lung cancer screening and helps them to consider their personal values when making a decision about whether to initiate or continue with lung cancer screening.
|
Control Group
n=69 Participants
Content that provides general information on disease prevention and health promotion unrelated to lung cancer. The information will be delivered on the same modality and take a similar amount of time to administer.
Control Intervention: This will be a health message regarding prevention and healthy behavior that is not related to lung cancer screening but delivered in a similar modality and taking approximately the same amount of time as the LCSDecTool.
|
|---|---|---|
|
Decisional Regret
|
32.6 Score on Decisional Regret Scale
Interval 30.1 to 35.1
|
34.5 Score on Decisional Regret Scale
Interval 31.9 to 37.1
|
SECONDARY outcome
Timeframe: Immediately post-intervention-the same day as the intervention following the interventionPopulation: There were 2 participants in the intervention group that did not complete the immediately post intervention survey and 2 participants in the control group that did not complete the immediately post-intervention survey.
Trait anxiety was measured using the State Trait Anxiety Index. This is a 20 item measure with scores ranging from 20 (low anxiety) to 80 (high anxiety).
Outcome measures
| Measure |
Intervention Group
n=67 Participants
Participants in this arm will use the lung cancer screening decision aid (LCSDecTool)
Lung Cancer Screening Decision Tool: This will be a lung cancer screening decision support tool that is web based and provides patients with information about the potential benefits and harms associated with lung cancer screening and helps them to consider their personal values when making a decision about whether to initiate or continue with lung cancer screening.
|
Control Group
n=69 Participants
Content that provides general information on disease prevention and health promotion unrelated to lung cancer. The information will be delivered on the same modality and take a similar amount of time to administer.
Control Intervention: This will be a health message regarding prevention and healthy behavior that is not related to lung cancer screening but delivered in a similar modality and taking approximately the same amount of time as the LCSDecTool.
|
|---|---|---|
|
Anxiety
|
33.5 units on a scale
Interval 30.7 to 36.3
|
32.8 units on a scale
Interval 29.8 to 35.9
|
SECONDARY outcome
Timeframe: 3 months post interventionPopulation: There were 9 participants in the intervention group that did not complete the 3 months follow up survey and 14 participants in the control group that did not complete the 3 months follow-up survey.
Anxiety was measured using the Trait items on the State Trait Anxiety Index with scores ranging from 20 (low anxiety) to 80 (high anxiety).
Outcome measures
| Measure |
Intervention Group
n=60 Participants
Participants in this arm will use the lung cancer screening decision aid (LCSDecTool)
Lung Cancer Screening Decision Tool: This will be a lung cancer screening decision support tool that is web based and provides patients with information about the potential benefits and harms associated with lung cancer screening and helps them to consider their personal values when making a decision about whether to initiate or continue with lung cancer screening.
|
Control Group
n=57 Participants
Content that provides general information on disease prevention and health promotion unrelated to lung cancer. The information will be delivered on the same modality and take a similar amount of time to administer.
Control Intervention: This will be a health message regarding prevention and healthy behavior that is not related to lung cancer screening but delivered in a similar modality and taking approximately the same amount of time as the LCSDecTool.
|
|---|---|---|
|
Anxiety
|
36.6 Scores on the State Trait Anxiety Index
Interval 33.6 to 39.7
|
38.2 Scores on the State Trait Anxiety Index
Interval 33.9 to 42.4
|
SECONDARY outcome
Timeframe: immediately post-intervention-the same day as the intervention following the intervention.Population: There were 2 participants in the intervention group and 2 participants in the control group that did not complete the immediately post-intervention survey.
Lung cancer worry was measured on a 3 point scale with scores ranging from 3 (low worry) to 13 (high worry)
Outcome measures
| Measure |
Intervention Group
n=67 Participants
Participants in this arm will use the lung cancer screening decision aid (LCSDecTool)
Lung Cancer Screening Decision Tool: This will be a lung cancer screening decision support tool that is web based and provides patients with information about the potential benefits and harms associated with lung cancer screening and helps them to consider their personal values when making a decision about whether to initiate or continue with lung cancer screening.
|
Control Group
n=69 Participants
Content that provides general information on disease prevention and health promotion unrelated to lung cancer. The information will be delivered on the same modality and take a similar amount of time to administer.
Control Intervention: This will be a health message regarding prevention and healthy behavior that is not related to lung cancer screening but delivered in a similar modality and taking approximately the same amount of time as the LCSDecTool.
|
|---|---|---|
|
Lung Cancer Worry
|
5.9 units on a scale
Interval 5.2 to 6.5
|
6.4 units on a scale
Interval 5.9 to 6.9
|
SECONDARY outcome
Timeframe: 3 months post-interventionPopulation: There were 9 participants in the intervention group and 14 participants in the control group that did not complete the 3 months post-intervention survey.
Lung Cancer Worry was measured on a 3 item scale with scores ranging from 3(low worry) to 13 (high worry)
Outcome measures
| Measure |
Intervention Group
n=60 Participants
Participants in this arm will use the lung cancer screening decision aid (LCSDecTool)
Lung Cancer Screening Decision Tool: This will be a lung cancer screening decision support tool that is web based and provides patients with information about the potential benefits and harms associated with lung cancer screening and helps them to consider their personal values when making a decision about whether to initiate or continue with lung cancer screening.
|
Control Group
n=57 Participants
Content that provides general information on disease prevention and health promotion unrelated to lung cancer. The information will be delivered on the same modality and take a similar amount of time to administer.
Control Intervention: This will be a health message regarding prevention and healthy behavior that is not related to lung cancer screening but delivered in a similar modality and taking approximately the same amount of time as the LCSDecTool.
|
|---|---|---|
|
Lung Cancer Worry
|
5.4 units on a scale
Interval 4.9 to 6.0
|
5.9 units on a scale
Interval 5.3 to 6.6
|
Adverse Events
Intervention Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Marilyn M Schapira, Senior Investigator, Center for Health Equity Research & Promotion (CHERP)
Philadelphia VA Medical Center (CMCVAMC), Philadelphia, PA
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place