Pre-Post Study for Supporting Appropriate Implementation of Lung Cancer Screening

NCT ID: NCT03077230

Last Updated: 2017-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-04-30

Brief Summary

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The primary objective of this study is to assess the effect of the decision aid on measures of decision-making such as knowledge, screening attitudes, decisional conflict, and screening intent.

Detailed Description

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Using a single group, pre-post design, we aim to assess the effect of the decision aid on screening knowledge, screening attitudes, decisional conflict, and screening intent within 3 months of decision aid viewing.

Conditions

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Lung Neoplasms Early Detection of Cancer Decision Support Techniques Primary Health Care

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Pre/Post Test of a Lung Cancer Screening Decision Aid

Group Type EXPERIMENTAL

Pre/Post Test of a Lung Cancer Screening Decision Aid

Intervention Type BEHAVIORAL

After completing the baseline survey, the research team member will ask each participant asked to view the lung cancer screening decision aid on a tablet. The following areas regarding lung cancer screening: What is lung cancer?, Why is lung cancer a problem?, What is screening?, What is low-dose CT screening, Recommended frequency of screening, Screening factors, lung cancer risks and benefits (magnitude of benefit, harms, false positive, invasive procedures, radiation, stress/anxiety), Summary, Values Clarification, Screening Choice, and Smoking cessation messaging for current smokers OR positive reinforcement for former smokers.

Interventions

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Pre/Post Test of a Lung Cancer Screening Decision Aid

After completing the baseline survey, the research team member will ask each participant asked to view the lung cancer screening decision aid on a tablet. The following areas regarding lung cancer screening: What is lung cancer?, Why is lung cancer a problem?, What is screening?, What is low-dose CT screening, Recommended frequency of screening, Screening factors, lung cancer risks and benefits (magnitude of benefit, harms, false positive, invasive procedures, radiation, stress/anxiety), Summary, Values Clarification, Screening Choice, and Smoking cessation messaging for current smokers OR positive reinforcement for former smokers.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age 55 - 80;
* Current smoker, or former smoker who has less than a 16-year quit history;
* Have at least a 30-pack year smoking history (average packs per day \* years smoking); and
* Patient of the Internal Medicine Clinic at University of North Carolina Health Care.

Exclusion Criteria

* Ever diagnosed with lung cancer;
* Undergone chemotherapy or radiation therapy in the past 18 months prior to enrollment;
* Coughed up blood from lungs (also called hemoptysis) within the past year prior to enrollment;
* Experienced unexplained weight loss of 15-pounds or more during six months prior to enrollment; and
* Had a chest CT scan within the past 18 months prior to enrollment.
Minimum Eligible Age

55 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel S Reuland, MD MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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UNC Ambulatory Care Center Internal Medicine Clinic

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

References

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National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.

Reference Type BACKGROUND
PMID: 21714641 (View on PubMed)

Kovalchik SA, Tammemagi M, Berg CD, Caporaso NE, Riley TL, Korch M, Silvestri GA, Chaturvedi AK, Katki HA. Targeting of low-dose CT screening according to the risk of lung-cancer death. N Engl J Med. 2013 Jul 18;369(3):245-254. doi: 10.1056/NEJMoa1301851.

Reference Type BACKGROUND
PMID: 23863051 (View on PubMed)

Bach PB, Gould MK. When the average applies to no one: personalized decision making about potential benefits of lung cancer screening. Ann Intern Med. 2012 Oct 16;157(8):571-3. doi: 10.7326/0003-4819-157-8-201210160-00524. No abstract available.

Reference Type BACKGROUND
PMID: 22893040 (View on PubMed)

Moyer VA; U.S. Preventive Services Task Force. Screening for lung cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2014 Mar 4;160(5):330-8. doi: 10.7326/M13-2771.

Reference Type BACKGROUND
PMID: 24378917 (View on PubMed)

Reuland DS, Cubillos L, Brenner AT, Harris RP, Minish B, Pignone MP. A pre-post study testing a lung cancer screening decision aid in primary care. BMC Med Inform Decis Mak. 2018 Jan 12;18(1):5. doi: 10.1186/s12911-018-0582-1.

Reference Type DERIVED
PMID: 29325548 (View on PubMed)

Related Links

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http://unclineberger.org

UNC Lineberger Home Page

Other Identifiers

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LCCC 1506

Identifier Type: -

Identifier Source: org_study_id