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Patient Navigation for Lung Cancer Screening (HEALS Trial)

N/A

Recruiting

Led By Vanessa Sheppard, PhD

Research Sponsored by Virginia Commonwealth University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Currently smokes or has quit smoking within the past 15 years

Has a 20 pack-year smoking history

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks to 4 months following day 1, varies by participant

Awards & highlights

HEALS Trial Summary

This trial tested if a patient navigation program improved the proportion of patients who completed lung cancer screening (LDCT).

Who is the study for?

This trial is for Black or African-American individuals who currently smoke or quit within the last 15 years, have a significant smoking history (20 pack-years), and meet USPSTF guidelines for lung cancer screening. They must be willing to participate in all study activities and sign consent forms. People with certain cancers, COPD, emphysema, recent coughing up blood, or conditions affecting study compliance can't join.Check my eligibility

What is being tested?

The trial is testing a patient navigation program's effectiveness in increasing the number of participants completing lung cancer screenings via low dose computed tomography (LDCT). It focuses on whether this educational support helps people follow through with recommended screenings.See study design

What are the potential side effects?

Since this trial involves an education and support program rather than medication or medical procedures, there are no direct side effects from interventions like drugs. However, stress or anxiety related to participation and findings from LCS may occur.

HEALS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a current smoker or quit smoking within the last 15 years.

Select...

I have smoked the equivalent of a pack a day for 20 years.

HEALS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks to 4 months following day 1, varies by participant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks to 4 months following day 1, varies by participant

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks to 4 months following day 1, varies by participant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of study patients who complete lung cancer screening (LCS) through the patient navigation process

Secondary outcome measures

Assess the feasibility and acceptability of the patient navigation program

Assess the impact of the patient navigation program on patient financial distress

Assess the impact of the patient navigation program on patient health-related quality of life after navigation intervention.

+1 more

HEALS Trial Design

1Treatment groups

Experimental Treatment

Group I: Patient NavigationExperimental Treatment1 Intervention

Centralized patient navigators will be trained to help patients navigate the clinical, logistical, and financial aspects of LCS. Navigators employ case management approaches based on social work principles. The experience of patient navigation will be tailored to the individual participant

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Patient Navigation

2017

Completed Phase 2

~38910

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor

699 Previous Clinical Trials

22,884,820 Total Patients Enrolled

Stand Up To CancerOTHER

51 Previous Clinical Trials

40,069 Total Patients Enrolled

Vanessa Sheppard, PhDPrincipal InvestigatorVirginia Commonwealth University

2 Previous Clinical Trials

167 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age of eligibility for this research endeavor limited to adults?

"This trial has established age restrictions for enrolment, with the minimum being 50 and the upper limit 80 years."

Answered by AI

Do I meet the requisite qualifications to partake in this clinical trial?

"This clinical trial is seeking out 225 participants aged 50 to 80, who have a lung cancer diagnosis and possess the following attributes: 20 pack-years of smoking history (where 1 pack-year equates to consuming an average of 20 cigarettes everyday for one year) and are either current smokers or quit within the last 15 years."

Answered by AI

Is this research inquiry open to new participants?

"According to the clinicaltrials.gov registry, this medical study is not presently recruiting participants. Although it was first publicized on November 30th 2023 and revised September 30th 2023, there are 1,634 other trials that require volunteers at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Health Education Approach to Lung Screening

2023. "Health Education Approach to Lung Screening". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06070870.

All > Lung Cancer Columbia