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

NCT ID: NCT02286713

Last Updated: 2021-02-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

516 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2020-12-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Lung Cancer Smoking Cessation Tobacco Use Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Patient Decision Aid

Decision Aid study materials including video mailed to participant with 1-week, 3-month, and 6-month Follow-up Assessments

Group Type ACTIVE_COMPARATOR

Patient Decision Aid

Intervention Type BEHAVIORAL

Participants will receive study materials including a video to watch about lung cancer screening

Follow-Up Assessments: Questionnaires

Intervention Type BEHAVIORAL

Follow up questions administered via phone and/or mail at 1-week, 3-month, and 6-month

Standard Educational Information

Study materials including education booklet mailed to participant with 1-week, 3-month, and 6-month Follow-up Assessments

Group Type ACTIVE_COMPARATOR

Standard Educational Information

Intervention Type BEHAVIORAL

Participants will receive study materials including a booklet to read about lung cancer screening.

Follow-Up Assessments: Questionnaires

Intervention Type BEHAVIORAL

Follow up questions administered via phone and/or mail at 1-week, 3-month, and 6-month

Interventions

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Patient Decision Aid

Participants will receive study materials including a video to watch about lung cancer screening

Intervention Type BEHAVIORAL

Standard Educational Information

Participants will receive study materials including a booklet to read about lung cancer screening.

Intervention Type BEHAVIORAL

Follow-Up Assessments: Questionnaires

Follow up questions administered via phone and/or mail at 1-week, 3-month, and 6-month

Intervention Type BEHAVIORAL

Other Intervention Names

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Video DVD Booklet Survey

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

77 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Volk, PhD

Role: STUDY_CHAIR

M.D. Anderson Cancer Center

Locations

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Information and Quality Healthcare (IQH)

Ridgeland, Mississippi, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32003822 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30010085 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Official Website

Other Identifiers

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NCI-2014-02492

Identifier Type: REGISTRY

Identifier Source: secondary_id

CER-1306-03385

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2014-0628

Identifier Type: -

Identifier Source: org_study_id

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