Promoting Informed Decisions About Lung Cancer Screening: Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 516
- Locations
- 1
- Primary Endpoint
- Mean Value: Preparation for Decision Making© Scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 55 Years to 77 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Patient Decision Aid
Decision Aid study materials including video mailed to participant with 1-week, 3-month, and 6-month Follow-up Assessments
Intervention: Patient Decision Aid (Behavioral)
Patient Decision Aid
Decision Aid study materials including video mailed to participant with 1-week, 3-month, and 6-month Follow-up Assessments
Intervention: Follow-Up Assessments: Questionnaires (Behavioral)
Standard Educational Information
Study materials including education booklet mailed to participant with 1-week, 3-month, and 6-month Follow-up Assessments
Intervention: Standard Educational Information (Behavioral)
Standard Educational Information
Study materials including education booklet mailed to participant with 1-week, 3-month, and 6-month Follow-up Assessments
Intervention: Follow-Up Assessments: Questionnaires (Behavioral)
Outcomes
Primary Outcomes
Mean Value: Preparation for Decision Making© Scale
Time Frame: 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©
Time Frame: 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©
Time Frame: 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 Outcomes
- Mean Value: Knowledge of Lung Cancer Screening(One week to 6 months, assessments at 1-week, 3-months and 6-months follow-up.)