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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

140 participants

Primary outcome timeframe

1 month following the intervention

Results posted on

2024-11-14

Participant Flow

Participant milestones

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

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

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 intervention

Population: 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

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 intervention

Population: 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

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 intervention

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 better outcome. Each correct response to an item is added to create the final score.

Outcome measures

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 intervention

Population: 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

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 intervention

Population: 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

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 intervention

Population: 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

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 intervention

Documentation of receiving a lung cancer screening test by 6 months following the intervention. This was obtained by chart review.

Outcome measures

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 months

A documented lung cancer screening test completed within 9 months of the intervention obtained by chart review

Outcome measures

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 intervention

Population: 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

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

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-intervention

Population: 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

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-intervention

Population: 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

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 intervention

Population: 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

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 intervention

Population: 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

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 intervention

Population: 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

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

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-intervention

Population: 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: 215 898 2022

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place