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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
First received
Last updated
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
Health authority
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.

Study Design


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 MakingĀ© 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 MakingĀ© 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.
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