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

Not Applicable

Completed

Conditions: Smoking Cessation
Lung Cancer
Tobacco Use Cessation

Interventions: Behavioral: Patient Decision Aid
Behavioral: Standard Educational Information

Registration Number: NCT02286713

Lead Sponsor: M.D. Anderson Cancer Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 516

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

History of lung cancer.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient Decision Aid	Patient Decision Aid	Decision Aid study materials including video mailed to participant with 1-week, 3-month, and 6-month Follow-up Assessments
Standard Educational Information	Standard Educational Information	Study materials including education booklet mailed to participant with 1-week, 3-month, and 6-month Follow-up Assessments

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.