Back to resultsPCORI-CER-1306-03385 Informed Decisions About Lung Cancer Screening
Primary Purpose
Lung Cancer, Smoking Cessation, Tobacco Use Cessation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Decision Aid
Standard Educational Information
Follow-Up Assessments: Questionnaires
Sponsored by
About this trial
This is an interventional health services research trial for Lung Cancer focused on measuring Lung Cancer Screening, heavy smokers, state-based smoking cessation quitlines, patient decision aid, low-dose computed tomography, LDCT, standard educational information
Eligibility Criteria
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:
1) History of lung cancer.
Sites / Locations
- Information and Quality Healthcare (IQH)
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Patient Decision Aid
Standard Educational Information
Arm Description
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
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02286713
First Posted
November 3, 2014
Last Updated
January 6, 2021
Sponsor
M.D. Anderson Cancer Center
Collaborators
Patient-Centered Outcomes Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02286713
Brief Title
PCORI-CER-1306-03385 Informed Decisions About Lung Cancer Screening
Official Title
Promoting Informed Decisions About Lung Cancer Screening: Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
Patient-Centered Outcomes Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Smoking Cessation, Tobacco Use Cessation
Keywords
Lung Cancer Screening, heavy smokers, state-based smoking cessation quitlines, patient decision aid, low-dose computed tomography, LDCT, standard educational information
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
516 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient Decision Aid
Arm Type
Active Comparator
Arm Description
Decision Aid study materials including video mailed to participant with 1-week, 3-month, and 6-month Follow-up Assessments
Arm Title
Standard Educational Information
Arm Type
Active Comparator
Arm Description
Study materials including education booklet mailed to participant with 1-week, 3-month, and 6-month Follow-up Assessments
Intervention Type
Behavioral
Intervention Name(s)
Patient Decision Aid
Other Intervention Name(s)
Video, DVD
Intervention Description
Participants will receive study materials including a video to watch about lung cancer screening
Intervention Type
Behavioral
Intervention Name(s)
Standard Educational Information
Other Intervention Name(s)
Booklet
Intervention Description
Participants will receive study materials including a booklet to read about lung cancer screening.
Intervention Type
Behavioral
Intervention Name(s)
Follow-Up Assessments: Questionnaires
Other Intervention Name(s)
Survey
Intervention Description
Follow up questions administered via phone and/or mail at 1-week, 3-month, and 6-month
Primary Outcome Measure Information:
Title
Mean Value: Preparation for Decision Making© Scale
Description
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.
Title
Mean Value: Informed Subscale of the Decisional Conflict Scale©
Description
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.
Title
Mean Value: Values Clarity Subscale of the Decisional Conflict Scale©
Description
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 Outcome Measure Information:
Title
Mean Value: Knowledge of Lung Cancer Screening
Description
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.
Time Frame
One week to 6 months, assessments at 1-week, 3-months and 6-months follow-up.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
77 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
1) History of lung cancer.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Volk, PhD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Information and Quality Healthcare (IQH)
City
Ridgeland
State/Province
Mississippi
ZIP/Postal Code
39157
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32003822
Citation
Volk RJ, Lowenstein LM, Leal VB, Escoto KH, Cantor SB, Munden RF, Rabius VA, Bailey L, Cinciripini PM, Lin H, Housten AJ, Luckett PG, Esparza A, Godoy MC, Bevers TB. Effect of a Patient Decision Aid on Lung Cancer Screening Decision-Making by Persons Who Smoke: A Randomized Clinical Trial. JAMA Netw Open. 2020 Jan 3;3(1):e1920362. doi: 10.1001/jamanetworkopen.2019.20362.
Results Reference
derived
PubMed Identifier
30010085
Citation
Lowenstein LM, Escoto KH, Leal VB, Bailey L, Bevers TB, Cantor SB, Cinciripini PM, Jacobs LE, Esparza A, Godoy MC, Housten AJ, Lin H, Luckett P, Munden RF, Rabius V, Volk RJ. Randomized trial of a patient-centered decision aid for promoting informed decisions about lung cancer screening: Implementation of a PCORI study protocol and lessons learned. Contemp Clin Trials. 2018 Sep;72:26-34. doi: 10.1016/j.cct.2018.07.007. Epub 2018 Jul 20.
Results Reference
derived
Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Official Website
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PCORI-CER-1306-03385 Informed Decisions About Lung Cancer Screening
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