A Community Health Worker Intervention to Improve Lung Cancer Screening Uptake in Community Health Centers

ConditionsLung Cancer Tobacco Use

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age50-80

SponsorBaystate Medical Center

About this trial

Lung cancer screening (LCS) can reduce lung cancer-related mortality by 20%, but only 5-10% of eligible individuals have received an initial LCS. The goal of this study is to partner with community stakeholders to jointly develop and pilot test a multi-component community health worker-delivered intervention targeting key barriers to improve LCS and tobacco treatment utilization. The proposed activities will lay the groundwork for a subsequent R01 grant, conducting a fully powered randomized clinical trial to establish CHWs as an evidence-based practice that will facilitate access to screening and tobacco treatment, to reduce lung cancer mortality.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults between the age of 50 and 80.

Potentially eligible for LCS according to the Electronic Health Record smoking history.

Receive their primary care at Mason Square, High Street, or Brightwood community health centers.

English- or Spanish- speaking.

Disqualifiers

Not eligible for lung cancer screening based on age (age < 50 or > 80 years) or smoking history (has not smoked more than 20 pack-years of tobacco cigarettes or quit more than 15 years ago).

Have received a lung cancer screen in the past.

Trial design

Design model

Parallel

Treatments tested in this trial

Community health worker delivered outreach, shared decision-making, tobacco treatment, and navigation
Behavioral
The CHW will perform: 1) patient outreach 2) patient-centered shared-decision making, 3) smoking cessation counseling, and 4) navigation of logistical barriers
Enhanced Usual Care
Other intervention
After randomization, the control group will receive the same mailed LCS educational materials as the intervention group and encouraged to discuss screening with their PCP, the typical pathway through which patients enter the LCS program.

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: Enhanced Usual CareActive comparator 1 intervention

Group B: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Feasiblity

Recruitment \& enrollment: # of participants approached, met eligibility, and randomized Baseline Measures (see Table 5): Completeness of data collection. Retention: Loss of follow-up, reason for discontinuation, completeness of post-intervention data

Time frame

once a month until study trial ends, an average one year

Fidelity

Duration of SDM and Smoking cessation Navigation: amount of time spent per call

Time frame

once a month until study trial ends, an average of 1 year

Fidelity

Completion of SDM and Smoking Cessation SDM OPTION Scale: measures 12 SDM items on a 5-point scale with response values ranging from "not observed" (value of 0) to "exhibited at a very high standard" (value of 4), with a total possible score ranging from 0 to 48. CMS SDM elements: reduced lung cancer mortality, false positive, overdiagnosis, radiation exposure, annual screening, smoking cessation, follow-up testing, and diagnostic procedures.

Time frame

once a month until study trial ends, an average of 1 year

Fidelity

SDM aid use and resources utilized

Time frame

once a month until study trial ends, an average of 1 year

Secondary outcomes

LCS referral

Referral for LCS: Order either by CHW or PCP referring participant to LCS program.

Time frame

3 months post study enrollment

LCS uptake

Receipt of LCS pre and post intervention

Time frame

Baseline and post intervention, 3 months post study enrollment

Tobacco Treatment receipt

Receipt of tobacco treatment: initiation and type of treatment

Time frame

3 months post study enrollment

Tobacco Treatment Duration

Duration of tobacco treatment and cessation attempts.

Time frame

3 months post study enrollment

Other outcomes

LCS knowledge

LCS knowledge LCS-12: 12-item instrument measuring LCS knowledge, indications for screening and potential risks

Time frame

Baseline and at 3 months post-enrollment

LCS beliefs and barriers

LCS Health Belief Scale: 35-item instrument based on the Expanded Health Belief Model that measures perceived risk of lung cancer (3 items), knowledge and perceived LCS benefits (6 items), perceived LCS barriers (17 items), and self-efficacy (9 items; e.g. patient confidence in ability to arrange and complete LCS). Item responses use a 4-point Likert scale (e.g. strongly agree to strongly disagree).

Time frame

At baseline and at 3 months post-enrollment

Trust in Navigator

Trust in Navigator Scale: 6-item instrument developed to measure interpersonal trust in a patient's navigator (i.e., the CHW), adapted from the trust in physician scale.

Time frame

3 months post-enrollment

Values-based SDM

SDM Process Survey: 4-item scale that measures whether the conversation discussed harms and benefits, and decisional preferences.

Time frame

3 months post-enrollment

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Baystate Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: