Lung Cancer, Smoking Cessation, Tobacco Use Cessation
Conditions
Keywords
Lung Cancer Screening, heavy smokers, state-based smoking cessation quitlines, patient decision aid, low-dose computed tomography, LDCT, standard educational information
Brief summary
Educational research study where goal is to test educational materials that help people make informed decisions about lung cancer screening.
Detailed description
This is the second phase of a larger project funded by the Patient-Centered Outcomes Research Institute to help heavy smokers make informed decisions about lung cancer screening with low-dose computed tomography (LDCT). The aim of this phase is to compare outcomes for promoting informed screening decisions about lung cancer screening in a randomized trial of patients who smoke recruited through state-based smoking cessation quitlines, where patients will be randomly assigned to the updated patient decision aid or to standard educational materials on lung cancer screening.
Interventions
BEHAVIORALFollow-Up Assessments: Questionnaires
Follow up questions administered via phone and/or mail at 1-week, 3-month, and 6-month
BEHAVIORALPatient Decision Aid
Participants will receive study materials including a video to watch about lung cancer screening
BEHAVIORALStandard Educational Information
Participants will receive study materials including a booklet to read about lung cancer screening.
Sponsors
Patient-Centered Outcomes Research Institute
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 77 Years
Healthy volunteers
Yes
Inclusion criteria
1. Men and women 55 to 77 years of age. 2. Participants must speak English. 3. Current smoker or quit smoking within the past 15 years. 4. At least a 30 pack-year smoking history.
Exclusion criteria
1\) History of lung cancer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Value: Preparation for Decision Making© Scale | Assessment at 1-week follow-up. | 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. |
| Mean Value: Informed Subscale of the Decisional Conflict Scale© | Assessment at 1-week follow-up. | 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. |
| Mean Value: Values Clarity Subscale of the Decisional Conflict Scale© | Assessment at 1-week follow-up. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Value: Knowledge of Lung Cancer Screening | One week to 6 months, assessments at 1-week, 3-months and 6-months follow-up. | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment Period: March 2015 to September 2016 from tobacco quitline new and former callers.
Pre-assignment details
After consent participants completed baseline assessments prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| Patient Decision Aid Decision Aid study materials including video mailed to participant with 1-week, 3-month, and 6-month follow-up assessments | 259 |
| Standard Educational Information Study materials including education booklet mailed to participant with 1-week, 3-month, and 6-month follow-up assessments | 257 |
| Total | 516 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 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 |
| Six Month Follow-Up | Death | 2 | 0 |
| Six Month Follow-Up | Lost to Follow-up | 30 | 27 |
| 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 |
Baseline characteristics
| Characteristic | Patient Decision Aid | Standard Educational Information | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 69 Participants | 77 Participants | 146 Participants |
| Age, Categorical Between 18 and 65 years | 190 Participants | 180 Participants | 370 Participants |
| Age, Continuous | 61.5 years STANDARD_DEVIATION 5 | 61.7 years STANDARD_DEVIATION 5.8 | 61.6 years STANDARD_DEVIATION 5.4 |
| Participant Education Level Graduated college or more | 39 Participants | 39 Participants | 78 Participants |
| Participant Education Level Graduated high school/GED | 72 Participants | 77 Participants | 149 Participants |
| Participant Education Level Less than High School | 41 Participants | 36 Participants | 77 Participants |
| Participant Education Level Some college/Trade school | 107 Participants | 105 Participants | 212 Participants |
| Participant Health Insurance Status Does not have insurance | 20 Participants | 27 Participants | 47 Participants |
| Participant Health Insurance Status Has insurance | 239 Participants | 230 Participants | 469 Participants |
| Participant Pack-Year Smoking History | 47.0 pack-years | 49.0 pack-years | 48.0 pack-years |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 62 Participants | 76 Participants | 138 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 7 Participants | 1 Participants | 8 Participants |
| Race/Ethnicity, Customized More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Refused | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 185 Participants | 177 Participants | 362 Participants |
| Region of Enrollment United States | 259 participants | 257 participants | 516 participants |
| Sex: Female, Male Female | 157 Participants | 163 Participants | 320 Participants |
| Sex: Female, Male Male | 102 Participants | 94 Participants | 196 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 259 | 1 / 257 |
| other Total, other adverse events | 0 / 259 | 0 / 257 |
| serious Total, serious adverse events | 0 / 259 | 0 / 257 |
Outcome results
Primary
Mean Value: Informed Subscale of the Decisional Conflict Scale©
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient Decision Aid | Mean Value: Informed Subscale of the Decisional Conflict Scale© | 27.1 units on a scale | Standard Deviation 25.9 |
| Standard Educational Information | Mean Value: Informed Subscale of the Decisional Conflict Scale© | 42.1 units on a scale | Standard Deviation 30.8 |
Primary
Mean Value: Preparation for Decision Making© Scale
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient Decision Aid | Mean Value: Preparation for Decision Making© Scale | 79.4 units on a scale | Standard Deviation 17.7 |
| Standard Educational Information | Mean Value: Preparation for Decision Making© Scale | 69.4 units on a scale | Standard Deviation 22.7 |
Primary
Mean Value: Values Clarity Subscale of the Decisional Conflict Scale©
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient Decision Aid | Mean Value: Values Clarity Subscale of the Decisional Conflict Scale© | 17.6 units on a scale | Standard Deviation 26.2 |
| Standard Educational Information | Mean Value: Values Clarity Subscale of the Decisional Conflict Scale© | 31.7 units on a scale | Standard Deviation 32.8 |
Secondary
Mean Value: Knowledge of Lung Cancer Screening
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patient Decision Aid | Mean Value: Knowledge of Lung Cancer Screening | One-week | 57.5 percentage of correct responses | Standard Deviation 21.8 |
| Patient Decision Aid | Mean Value: Knowledge of Lung Cancer Screening | 6-Months | 49.9 percentage of correct responses | Standard Deviation 17.8 |
| Patient Decision Aid | Mean Value: Knowledge of Lung Cancer Screening | 3-Months | 44.4 percentage of correct responses | Standard Deviation 19.6 |
| Standard Educational Information | Mean Value: Knowledge of Lung Cancer Screening | One-week | 40.1 percentage of correct responses | Standard Deviation 17.1 |
| Standard Educational Information | Mean Value: Knowledge of Lung Cancer Screening | 3-Months | 35.9 percentage of correct responses | Standard Deviation 16.9 |
| Standard Educational Information | Mean Value: Knowledge of Lung Cancer Screening | 6-Months | 40.0 percentage of correct responses | Standard Deviation 18.1 |