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PCORI-CER-1306-03385 Lung Cancer Screening Decision Aid Development and Testing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02282969
Recruitment Status : Active, not recruiting
First Posted : November 5, 2014
Last Update Posted : January 24, 2018
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

Objectives:

This protocol addresses the first 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 (CT). A separate IRB protocol will be submitted for the larger, comparative study. In this initial development phase, our prototype patient decision aid will be updated to reflect current guidelines about lung cancer screening. The updated aid will then be pilot-tested in a new sample of patients. In addition, several of the study measures will be refined and further developed in preparation for the larger study.

The specific aims of the measures and decision aid development phase of this project are as follows:

Update the aid to reflect current screening guidelines and refine the aid via cognitive testing with patients/smokers; and pilot test the updated aid for acceptability with patients/smokers.

Modify our current measure of lung cancer knowledge, conduct cognitive testing of the new measure with patients/smokers, and evaluate the reliability of the new measure in a sample patients/smokers.


Condition or disease Intervention/treatment
Health Knowledge, Attitudes, Practice Behavioral: Interviews Behavioral: Questionnaires

Detailed Description:

Cognitive and Pilot Testing:

If you agree to take part in this study, you will take part in an interview with a member of the research staff. The interviewer will take notes of your responses. First, you will be asked some questions about you, like your age, sex, race, and education level. Then you will be asked to look at some educational materials about lung cancer screening. These could be written information, animations, graphics, videos, or questionnaires. You may be asked questions about:

  • Lung cancer and lung cancer screening
  • The length of the materials
  • The balance of the information found in the materials

The study interview will take place in person at MD Anderson and will take between 1 and 1 ½ hours.

Your participation on this study will be over once the interview is complete.

This is an investigational study.

Up to 50 participants will be enrolled in this part of the study. All will take part at MD Anderson, UTMB, the Galveston community, or tobacco-related community events.

Measures Reliability Study:

If you agree to take part in this study, you will complete a questionnaire 2 times. The questionnaire will ask about:

  • Lung cancer
  • Lung cancer screening
  • Making decisions about screening
  • Your age, race, gender, and level of education

You will complete the first questionnaire in person. It will take about 20 minutes to fill out. Then, about 1 month later, you will be asked to fill out the questionnaire again.

The second time you can come in person, or fill out the questionnaire by mail or telephone. Your participation will be over when the second questionnaire is complete.

This is an investigational study.

Up to 150 participants will be enrolled in this part of the study. All will take part at MD Anderson, UTMB, the Galveston community, or tobacco-related community events.


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Study Type : Observational
Actual Enrollment : 161 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Promoting Informed Decisions About Lung Cancer Screening: Decision Aid Update and Measures Development
Actual Study Start Date : July 11, 2014
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Group/Cohort Intervention/treatment
Lung Cancer Screening Decision Aids
Participants are asked to look over education materials about lung cancer screening, and interviewed. Some participants will look at a video patient decision aid, with an interview and questionnaire completion. Some participants complete lung cancer screening knowledge questionnaire at first visit, and then again in one month.
Behavioral: Interviews
Interviews performed by study staff encompassing lung cancer screening and patient decision aids.

Behavioral: Questionnaires
Questionnaires completed after viewing patient decision aid video. Questionnaires also completed regarding lung cancer screening knowledge at first visit, then again in one month.
Other Name: Surveys




Primary Outcome Measures :
  1. Informed Decisions About Lung Cancer Screening (Data from interviews and questionnaires reviewed to assess participant knowledge) [ Time Frame: 1 Month ]
    Data from interviews and questionnaires reviewed to assess participant knowledge regarding lung cancer screening and decision aid.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants recruited from Houston and Galveston areas.
Criteria

Inclusion Criteria:

  1. Men and women 55 to 80 years of age.
  2. Participants must speak English.
  3. Current smoker or quit smoking within the past 15 years.

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): NCT02282969


Locations
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United States, Texas
The University of Texas Medical Branch at Galveston
Galveston, Texas, United States, 77555
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
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
Principal Investigator: Suzanne Linder, PHD The University of Texas Medical Branch at Galveston
Principal Investigator: Paul Cinciripini, PHD, MS, BS M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02282969     History of Changes
Other Study ID Numbers: PA14-0072
CER-1306-03385 ( Other Grant/Funding Number: Patient Centered Outcomes Research Institute )
First Posted: November 5, 2014    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018

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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:
Cancer Prevention
Smokers
Quit smoking
Interviews
Questionnaires
Surveys
Lung cancer screening
Patient decision aid

Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases