Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

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Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Decision Aid study materials including video mailed to participant with 1-week, 3-month, and 6-month Follow-up Assessments

Study materials including education booklet mailed to participant with 1-week, 3-month, and 6-month Follow-up Assessments

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

Patient Decision Aid

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

Standard Educational Information

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

Follow-Up Assessments: Questionnaires

Robert Volk, PhD

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.

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

Promoting Informed Decisions About Lung Cancer Screening: Randomized Trial

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.

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.

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.

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.

Patient-Centered Outcomes Research Institute

M.D. Anderson Cancer Center

Decision Aid study materials including video mailed to participant with 1-week, 3-month, and 6-month follow-up assessments

Study materials including education booklet mailed to participant with 1-week, 3-month, and 6-month follow-up assessments

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race/Ethnicity, Customized

United States

Region of Enrollment

Pack-year smoking history, where one pack-year is equivalent to smoking one pack of cigarettes daily (20 cigarettes) for one year. A 30-pack-year smoking history is an eligibility criterion for lung cancer screening.

Participant Pack-Year Smoking History

Participant Education Level

Participant Health Insurance Status

Clinical Research Operations Team, Office of VP Clinical Research

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.

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.

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.

One-week

3-Months

6-Months

For the participants providing data at the 1-week follow-up, no data was missing in either group.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
PCORI-CER-1306-03385 Informed Decisions About Lung Cancer Screening	NCT02286713	Lung Cancer Smoking Cessati... Tobacco Use Ces...	Patient Decisio... Standard Educat... Follow-Up Asses...	55 Years - 77 Years	M.D. Anderson Cancer Center
PCORI-CER-1306-03385 Informed Decisions About Lung Cancer Screening	NCT02286713	Lung Cancer Smoking Cessati... Tobacco Use Ces...	Patient Decisio... Standard Educat... Follow-Up Asses...	55 Years - 77 Years	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for standard educational information