PCORI-CER-1306-03385 Informed Decisions About Lung Cancer Screening

Study Overview
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Brief Summary
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Educational research study where goal is to test educational materials that help people make informed decisions about lung cancer screening.

Detailed Description
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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.

Official Title
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Promoting Informed Decisions About Lung Cancer Screening: Randomized Trial

Conditions
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Lung Cancer, Smoking Cessation, Tobacco Use Cessation

Intervention / Treatment
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* Behavioral: Patient Decision Aid
* Behavioral: Standard Educational Information
* Behavioral: Follow-Up Assessments: Questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women 55 to 77 years of age. Participants must speak English. Current smoker or quit smoking within the past 15 years. At least a 30 pack-year smoking history. Exclusion Criteria: 1) History of lung cancer.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 77 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patient Decision Aid<br>Decision Aid study materials including video mailed to participant with 1-week, 3-month, and 6-month Follow-up Assessments | Behavioral: Patient Decision Aid<br>* Participants will receive study materials including a video to watch about lung cancer screening<br>* Other names: DVD;Behavioral: Follow-Up Assessments: Questionnaires<br>* Follow up questions administered via phone and/or mail at 1-week, 3-month, and 6-month<br>* Other names: Survey;|
| Active Comparator: Standard Educational Information<br>Study materials including education booklet mailed to participant with 1-week, 3-month, and 6-month Follow-up Assessments | Behavioral: Standard Educational Information<br>* Participants will receive study materials including a booklet to read about lung cancer screening.<br>* Other names: Booklet;Behavioral: Follow-Up Assessments: Questionnaires<br>* Follow up questions administered via phone and/or mail at 1-week, 3-month, and 6-month<br>* Other names: Survey;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Assessment at 1-week follow-up. | 
| 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. | Assessment at 1-week follow-up. | 
| 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. | Assessment at 1-week follow-up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | One week to 6 months, assessments at 1-week, 3-months and 6-months follow-up. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Cancer Screening, heavy smokers, state-based smoking cessation quitlines, patient decision aid, low-dose computed tomography, LDCT, standard educational information