NCT02286713

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
516

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 10, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

July 15, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

Enrollment Period

5.8 years

First QC Date

November 3, 2014

Results QC Date

September 28, 2017

Last Update Submit

January 6, 2021

Conditions

Lung CancerSmoking CessationTobacco Use Cessation

Keywords

Lung Cancer Screeningheavy smokersstate-based smoking cessation quitlinespatient decision aidlow-dose computed tomographyLDCTstandard educational information

Outcome Measures

Primary Outcomes (3)

  • Mean Value: Preparation for Decision Making© Scale

    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©

    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©

    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 Outcomes (1)

  • Mean Value: Knowledge of Lung Cancer Screening

    One week to 6 months, assessments at 1-week, 3-months and 6-months follow-up.

Study Arms (2)

Patient Decision Aid

ACTIVE COMPARATOR

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

Behavioral: Patient Decision AidBehavioral: Follow-Up Assessments: Questionnaires

Standard Educational Information

ACTIVE COMPARATOR

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

Behavioral: Standard Educational InformationBehavioral: Follow-Up Assessments: Questionnaires

Interventions

Patient Decision AidBEHAVIORAL

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

Also known as: Video, DVD
Patient Decision Aid
Standard Educational InformationBEHAVIORAL

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

Also known as: Booklet
Standard Educational Information
Follow-Up Assessments: QuestionnairesBEHAVIORAL

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

Also known as: Survey
Patient Decision AidStandard Educational Information

Eligibility Criteria

Age55 Years - 77 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women 55 to 77 years of age.
  • Participants must speak English.
  • Current smoker or quit smoking within the past 15 years.
  • At least a 30 pack-year smoking history.

You may not qualify if:

  • \) History of lung cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Information and Quality Healthcare (IQH)

Ridgeland, Mississippi, 39157, United States

Location

Related Publications (2)

  • 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.

    PMID: 32003822DERIVED

  • 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.

    PMID: 30010085DERIVED

Related Links

MeSH Terms

Conditions

Lung NeoplasmsSmoking CessationTobacco Use Cessation

Interventions

Videotape RecordingSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevisionData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Results Point of Contact

Title
Clinical Research Operations Team, Office of VP Clinical Research
Organization
UT MD Anderson Cancer Center
CR_Study_Registration@mdanderson.org
713-792-7734

Study Officials

  • Robert Volk, PhD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2014

First Posted

November 10, 2014

Study Start

March 1, 2015

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

February 1, 2021

Results First Posted

July 15, 2019

Record last verified: 2021-01

Locations

US(1)