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

January 6, 2021 updated by: M.D. Anderson Cancer Center

Promoting Informed Decisions About Lung Cancer Screening: Randomized Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

516

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Mississippi
      • Ridgeland, Mississippi, United States, 39157
        • Information and Quality Healthcare (IQH)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 77 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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: Follow-Up Assessments: Questionnaires
Follow up questions administered via phone and/or mail at 1-week, 3-month, and 6-month
Other Names:
  • Survey
Behavioral: Standard Educational Information
Participants will receive study materials including a booklet to read about lung cancer screening.
Other Names:
  • Booklet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessment at 1-week follow-up.
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.
Assessment at 1-week follow-up.
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.
Assessment at 1-week follow-up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One week to 6 months, assessments at 1-week, 3-months and 6-months follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

Patient-Centered Outcomes Research Institute

Investigators

  • Study Chair: Robert Volk, PHD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

December 30, 2020

Study Completion (Actual)

December 30, 2020

Study Registration Dates

First Submitted

November 3, 2014

First Submitted That Met QC Criteria

November 5, 2014

First Posted (Estimate)

November 10, 2014

Study Record Updates

Last Update Posted (Actual)

February 1, 2021

Last Update Submitted That Met QC Criteria

January 6, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-0628
  • CER-1306-03385 (Other Grant/Funding Number: Patient Centered Outcomes Research Institute)
  • NCI-2014-02492 (Registry Identifier: NCI CTRP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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