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

M.D. Anderson Cancer Center516 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

516

Conditions

Lung Cancer Smoking Cessation Tobacco Use Cessation

Interventions

Patient Decision AidBEHAVIORAL

Participants will receive study materials including a video to watch about lung cancer screening

Standard Educational InformationBEHAVIORAL

Participants will receive study materials including a booklet to read about lung cancer screening.

Follow-Up Assessments: QuestionnairesBEHAVIORAL

Follow up questions administered via phone and/or mail at 1-week, 3-month, and 6-month

Eligibility

Sex: ALLMin age: 55 YearsMax age: 77 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Information and Quality Healthcare (IQH)

Ridgeland, Mississippi, United States

Outcomes

Primary Outcomes

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.

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.

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.

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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