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Improving Implementation of Lung Cancer Screening in Diverse Populations II

Primary Purpose

Early Detection of Cancer, Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CAQ
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Early Detection of Cancer focused on measuring lung cancer screening, low-dose chest CT scan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Has undergone LCS or is referred for LCS
  • Able to give informed consent

Exclusion Criteria:

  • Cognitive or language limitations (i.e., expressive language limitations, non-English speaking
  • Known malignancy other than non-melanoma skin cancer

Sites / Locations

  • Seattle Cancer Care Alliance

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

CAQ

Arm Description

Brief form letter with lung cancer screening results

Usual care, plus "Commonly Asked Questions after Lung Cancer Screening" informational document (CAQ)

Outcomes

Primary Outcome Measures

Patient Understanding
Ratings of "I understand the results of my most recent LCS CT scan" on a Likert Scale
Patient Next Step
Correct self-report of next step based on Lung-RADS standardized follow-up
Patient Distress
Symptoms of distress based on Impact of Event Scale (IES)
CAQ Appropriateness and Acceptability
Survey questions soliciting patient opinion of CAQ

Secondary Outcome Measures

Other Patient Knowledge and Understanding
Survey questions regarding knowledge and understanding of essential components of lung cancer screening and results

Full Information

First Posted
February 4, 2022
Last Updated
February 22, 2022
Sponsor
University of Washington
Collaborators
American Lung Association
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1. Study Identification

Unique Protocol Identification Number
NCT05265897
Brief Title
Improving Implementation of Lung Cancer Screening in Diverse Populations II
Official Title
Improving Implementation of Lung Cancer Screening in Diverse Populations II
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
American Lung Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This project assesses the feasibility, appropriateness, and acceptability of a "Commonly Asked Questions after Lung Cancer Screening" (CAQ) informational document that the investigators created, resulting from patient and provider discussion in focus groups and interviews. If effective, the CAQ may be a new tool to help improve patient understanding of LCS results and adherence to follow-up recommendations.
Detailed Description
Barriers to optimal implementation of lung cancer screening (LCS) include low levels of patient knowledge. Patient understanding of LCS results may alleviate distress and improve understanding of recommendations. The investigators developed a "Commonly Asked Questions after LCS" (CAQ) information sheet based on gaps in knowledge identified by patient focus groups and provider interviews. The study objective was to assess CAQ appropriateness and acceptability, and preliminary impact on patient understanding and distress after receiving LCS results. The investigators conducted a pilot alternating intervention controlled trial of the CAQ. All patients in the University of Washington/Seattle Cancer Care Alliance LCS program who underwent baseline or annual LCS were received a mailing within one week of their scan, either: 1) usual care: a brief form letter with screening results; or 2) usual care plus the CAQ (intervention). The mailing assignment was alternated weekly. Mailed follow-up surveys assessed appropriateness and acceptability of CAQ as well as LCS knowledge in the intervention group. Primary outcomes include: 1) Ratings of "I understand the results of my most recent LCS CT scan" on a Likert Scale; 2) Correct self-report of next step based on Lung-RADS standardized follow-up; 3) symptoms of distress (measured by IES); as well as 4) measures of acceptability and appropriateness. Secondary outcomes include responses to 6 questions regarding lung cancer screening knowledge.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Detection of Cancer, Lung Cancer
Keywords
lung cancer screening, low-dose chest CT scan

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Alternating intervention controlled trial where treatment assignment was alternated weekly. Participants who underwent baseline or annual lung cancer screening were assigned to receive a mailing within one week of their scan, either: 1) usual care: a brief form letter with screening results; or 2) usual care plus "Commonly Asked Questions" informational document (intervention).
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Brief form letter with lung cancer screening results
Arm Title
CAQ
Arm Type
Experimental
Arm Description
Usual care, plus "Commonly Asked Questions after Lung Cancer Screening" informational document (CAQ)
Intervention Type
Other
Intervention Name(s)
CAQ
Intervention Description
Informational document
Primary Outcome Measure Information:
Title
Patient Understanding
Description
Ratings of "I understand the results of my most recent LCS CT scan" on a Likert Scale
Time Frame
1 week post-randomization
Title
Patient Next Step
Description
Correct self-report of next step based on Lung-RADS standardized follow-up
Time Frame
1 week post-randomization
Title
Patient Distress
Description
Symptoms of distress based on Impact of Event Scale (IES)
Time Frame
1 week post-randomization
Title
CAQ Appropriateness and Acceptability
Description
Survey questions soliciting patient opinion of CAQ
Time Frame
1 week post-randomization
Secondary Outcome Measure Information:
Title
Other Patient Knowledge and Understanding
Description
Survey questions regarding knowledge and understanding of essential components of lung cancer screening and results
Time Frame
1 week post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has undergone LCS or is referred for LCS Able to give informed consent Exclusion Criteria: Cognitive or language limitations (i.e., expressive language limitations, non-English speaking Known malignancy other than non-melanoma skin cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristina A Cothers, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

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Improving Implementation of Lung Cancer Screening in Diverse Populations II

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