Early Detection of CancerNCT05265897
Improving Implementation of Lung Cancer Screening in Diverse Populations II
A study testing CAQ in people with Early Detection of Cancer and Lung Cancer, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Detection of Cancer, Lung Cancer
- What is being tested?
- CAQ
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has undergone LCS or is referred for LCS
- Able to give informed consent
Who cannot join
- Cognitive or language limitations (i.e., expressive language limitations, non-English speaking
- Known malignancy other than non-melanoma skin cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Cancer Care Alliance
Seattle, Washington, 98109
About this study
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.
Read the 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.
- Conditions
- Early Detection of Cancer, Lung Cancer
- Being tested
- CAQ
- Keywords
- lung cancer screening, low-dose chest CT scan
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAQOther
Informational document
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Brief form letter with lung cancer screening results |
| CAQ | Experimental | Usual care, plus "Commonly Asked Questions after Lung Cancer Screening" informational document (CAQ) Receives: Other: CAQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Understanding
Ratings of "I understand the results of my most recent LCS CT scan" on a Likert Scale
Measured: 1 week post-randomization
Patient Next Step
Correct self-report of next step based on Lung-RADS standardized follow-up
Measured: 1 week post-randomization
Patient Distress
Symptoms of distress based on Impact of Event Scale (IES)
Measured: 1 week post-randomization
CAQ Appropriateness and Acceptability
Survey questions soliciting patient opinion of CAQ
Measured: 1 week post-randomization
Secondary outcomes (1)
Other Patient Knowledge and Understanding
Survey questions regarding knowledge and understanding of essential components of lung cancer screening and results
Measured: 1 week post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start1 Dec 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early Detection of CancerStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- American Lung Association
- Responsible party
- Principal investigator, Kristina Anne Crothers, University of Washington
- Investigators
- Kristina A Cothers, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265897
- Sponsor's protocol ID
- SITE00000215
- Status last verified
- Feb 2022
- First submitted
- 4 Feb 2022
- Last updated
- 4 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Triplette M, Kross EK, Snidarich M, Shahrir S, Hippe DS, Crothers K. An alternating-intervention pilot trial on the impact of an informational handout on patient-reported outcomes and follow-up after lung cancer screening. PLoS One. 2024 Apr 10;19(4):e0300352. doi: 10.1371/journal.pone.0300352. eCollection 2024.
PubMed 38598511
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Implementation of Lung Cancer Screening in Diverse Populations II
- ClinicalTrials.gov ID
- NCT05265897
- Acronym / sponsor ID
- SITE00000215
- Conditions
- Early Detection of Cancer, Lung Cancer
- Keywords
- lung cancer screening, low-dose chest CT scan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- American Lung Association
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 4 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Brief form letter with lung cancer screening results |
| CAQ | Experimental | Other: CAQUsual care, plus "Commonly Asked Questions after Lung Cancer Screening" informational document (CAQ) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Has undergone LCS or is referred for LCS
- Able to give informed consent
Key exclusion criteria (2 listed)
- Cognitive or language limitations (i.e., expressive language limitations, non-English speaking
- Known malignancy other than non-melanoma skin cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAQInformational document | Other | CAQ |
Primary outcome
Patient Understanding
Time frame: 1 week post-randomization
Ratings of "I understand the results of my most recent LCS CT scan" on a Likert Scale
Patient Next Step
Time frame: 1 week post-randomization
Correct self-report of next step based on Lung-RADS standardized follow-up
Patient Distress
Time frame: 1 week post-randomization
Symptoms of distress based on Impact of Event Scale (IES)
CAQ Appropriateness and Acceptability
Time frame: 1 week post-randomization
Survey questions soliciting patient opinion of CAQ
1 secondary outcome
Other Patient Knowledge and Understanding
Time frame: 1 week post-randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Derived from this study: PubMed 38598511Triplette M, Kross EK, Snidarich M, Shahrir S, Hippe DS, Crothers K. An alternating-intervention pilot trial on the impact of an informational handout on patient-reported outcomes and follow-up after lung cancer screening. PLoS One. 2024 Apr 10;19(4):e0300352. doi: 10.1371/journal.pone.0300352. eCollection 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristina A Cothers, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAQ in people with Early Detection of Cancer and Lung Cancer, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Understanding (time frame: 1 week post-randomization). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05265897, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2022; AzTrials last refreshed its copy on 7 Nov 2026.