A Patient and Provider Intervention to Address Health Disparities in Lung Cancer Screening

NCT ID: NCT04675476

Last Updated: 2024-12-27

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

RECRUITING

Clinical Phase

NA

Total Enrollment

368 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-11

Study Completion Date

2026-02-28

Brief Summary

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

Detailed Description

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The proposed study will target two key levels of influence in the healthcare setting: provider and patient behavior in order to address disparities between African American and whites in lung screening awareness and utilization. Guided by NIH's Health Disparities Research Framework and building on the formative work conducted in the K99 phase, we will conduct a quasi-experimental study (pretest-posttest, with a nonequivalent control group) in partnership with four primary care clinics within the MedStar Health system in the R00 phase.

Conditions

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Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Multilevel Intervention

Group Type EXPERIMENTAL

Provider Prompt & Patient Outreach and Education

Intervention Type BEHAVIORAL

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.

Nonequivalent Control Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Provider Prompt & Patient Outreach and Education

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 50-80 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

Exclusion Criteria

* Individuals with a history of lung cancer
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Georgetown University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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MedStar Health

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Randi M Williams, PhD

Role: CONTACT

Phone: (202) 687-7036

Email: [email protected]

Facility Contacts

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Andrew Canning

Role: primary

References

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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.

Reference Type DERIVED
PMID: 40231692 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38365820 (View on PubMed)

Other Identifiers

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STUDY00003277

Identifier Type: -

Identifier Source: org_study_id