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

Lung Cancer Clinical Trial

Official title:

Promoting Informed Decisions About Lung Cancer Screening: Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02286713
• Other study ID #: 2014-0628
• Secondary ID: NCI-2014-02492CE
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: December 30, 2020

Study information

• Verified date: January 2021
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 516
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 77 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Smoking Cessation
• Tobacco Use Cessation

Intervention

Behavioral:
• Patient Decision Aid
Participants will receive study materials including a video to watch about lung cancer screening
• Standard Educational Information
Participants will receive study materials including a booklet to read about lung cancer screening.
• Follow-Up Assessments: Questionnaires
Follow up questions administered via phone and/or mail at 1-week, 3-month, and 6-month

Locations

Country	Name	City	State
United States	Information and Quality Healthcare (IQH)	Ridgeland	Mississippi

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.

External Links

•   University of Texas MD Anderson Cancer Center Official Website