NCT04675476

Brief Summary

To test the impact of a multilevel intervention on primary (provider-patient communication, intentions, and knowledge) and secondary (screening referrals and completion) outcomes.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
368

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

December 4, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 19, 2020

Completed
3.2 years until next milestone

Study Start

First participant enrolled

March 11, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

1.8 years

First QC Date

December 4, 2020

Last Update Submit

December 23, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • provider-patient discussion

    Discussion about lung screening with the provider ('did you have a discussion with your doctor about lung screening?')

    1-week post-visit

  • lung cancer screening intentions

    Screening intentions ('how likely is it that you will undergo lung screening in the next 6-months?')

    1-week post-visit

  • lung cancer screening knowledge

    Lung cancer screening knowledge measure

    1-week post-visit

Secondary Outcomes (2)

  • lung cancer screening referrals

    6-months

  • lung cancer screening completion rates

    6-months

Study Arms (2)

Multilevel Intervention

EXPERIMENTAL
Behavioral: Provider Prompt & Patient Outreach and Education

Nonequivalent Control Group

NO INTERVENTION

Interventions

To target lack of provider-prompted discussion about lung screening, an electronic medical record (EMR) message will be sent to primary care providers prior to scheduled visits with screening-eligible patients to notify them of the patient's eligibility and to encourage discussion of the benefits and limitations of the test. To target patient-level knowledge about lung screening, an outreach specialist will educate screening-eligible patients about the benefits and limitations of the test prior to their visit.

Multilevel Intervention

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old;
  • current cigarette smoker or quit within 15 years;
  • a 20+ pack-year smoking history;
  • non-adherent to lung screening (\>13 months);
  • English-speaking;
  • scheduled for an upcoming clinic appointment (4 weeks - 8 weeks); and
  • able and willing to provide meaningful consent and complete telephone interviews

You may not qualify if:

  • Individuals with a history of lung cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MedStar Health

Washington D.C., District of Columbia, 20007, United States

RECRUITING

Related Publications (2)

  • Williams RM, Whealan J, Sangraula A, Taylor KL, Adams-Campbell L, Miller KE, Glassmeyer K, Yee P, Camidge K, Foley K, Luta G, Lin KW, Barnes R, DuBoyce WF. Providing Reminders and Education Prior to lung cancer screening: Feasibility and acceptability of a multilevel approach to address disparities in lung cancer screening. Transl Behav Med. 2025 Jan 16;15(1):ibaf008. doi: 10.1093/tbm/ibaf008.

  • Williams RM, Whealan J, Taylor KL, Adams-Campbell L, Miller KE, Foley K, Luta G, Brandt H, Glassmeyer K, Sangraula A, Yee P, Camidge K, Blumenthal J, Modi S, Kratz H. Multilevel approaches to address disparities in lung cancer screening: a study protocol. Implement Sci Commun. 2024 Feb 16;5(1):15. doi: 10.1186/s43058-024-00553-4.

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Central Study Contacts

Randi M Williams, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2020

First Posted

December 19, 2020

Study Start

March 11, 2024

Primary Completion

December 31, 2025

Study Completion

February 28, 2026

Last Updated

December 27, 2024

Record last verified: 2024-12

Locations