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

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ClinicalTrials.gov Identifier: NCT02286713
Recruitment Status : Completed
First Posted : November 10, 2014
Results First Posted : July 15, 2019
Last Update Posted : February 1, 2021
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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

Condition or disease Intervention/treatment Phase
Lung Cancer Smoking Cessation Tobacco Use Cessation Behavioral: Patient Decision Aid Behavioral: Standard Educational Information Behavioral: Follow-Up Assessments: Questionnaires Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 516 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Promoting Informed Decisions About Lung Cancer Screening: Randomized Trial
Actual Study Start Date : March 2015
Actual Primary Completion Date : December 30, 2020
Actual Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Patient Decision Aid
Decision Aid study materials including video mailed to participant with 1-week, 3-month, and 6-month Follow-up Assessments
Behavioral: Patient Decision Aid
Participants will receive study materials including a video to watch about lung cancer screening
Other Names:
  • Video
  • DVD

Behavioral: Follow-Up Assessments: Questionnaires
Follow up questions administered via phone and/or mail at 1-week, 3-month, and 6-month
Other Name: Survey

Active Comparator: Standard Educational Information
Study materials including education booklet mailed to participant with 1-week, 3-month, and 6-month Follow-up Assessments
Behavioral: Standard Educational Information
Participants will receive study materials including a booklet to read about lung cancer screening.
Other Name: Booklet

Behavioral: Follow-Up Assessments: Questionnaires
Follow up questions administered via phone and/or mail at 1-week, 3-month, and 6-month
Other Name: Survey




Primary Outcome Measures :
  1. Mean Value: Preparation for Decision Making© Scale [ Time Frame: Assessment at 1-week follow-up. ]
    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.

  2. Mean Value: Informed Subscale of the Decisional Conflict Scale© [ 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.

  3. Mean Value: Values Clarity Subscale of the Decisional Conflict Scale© [ 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.


Secondary Outcome Measures :
  1. Mean Value: Knowledge of Lung Cancer Screening [ Time Frame: One week to 6 months, assessments at 1-week, 3-months and 6-months follow-up. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 77 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02286713


Locations
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United States, Mississippi
Information and Quality Healthcare (IQH)
Ridgeland, Mississippi, United States, 39157
Sponsors and Collaborators
M.D. Anderson Cancer Center
Patient-Centered Outcomes Research Institute
Investigators
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Study Chair: Robert Volk, PhD M.D. Anderson Cancer Center
  Study Documents (Full-Text)

Documents provided by M.D. Anderson Cancer Center:
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02286713    
Other Study ID Numbers: 2014-0628
NCI-2014-02492 ( Registry Identifier: NCI CTRP )
CER-1306-03385 ( Other Grant/Funding Number: Patient Centered Outcome Research Institute )
First Posted: November 10, 2014    Key Record Dates
Results First Posted: July 15, 2019
Last Update Posted: February 1, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Lung Cancer Screening
heavy smokers
state-based smoking cessation quitlines
patient decision aid
low-dose computed tomography
LDCT
standard educational information
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases