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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
Must not have
Inability to speak English
Known history of cancer (except squamous cell skin cancer), chronic obstructive pulmonary disease (COPD), emphysema, or coughing up blood in the past 5 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks to 4 months following day 1, varies by participant
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot speak English.
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I have not had cancer (except skin cancer), COPD, emphysema, or coughed up blood in the last 5 years.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of study patients who complete lung cancer screening (LCS) through the patient navigation process
Secondary study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
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Who is running the clinical trial?
Virginia Commonwealth UniversityLead Sponsor
719 Previous Clinical Trials
22,895,611 Total Patients Enrolled
Stand Up To CancerOTHER
52 Previous Clinical Trials
39,896 Total Patients Enrolled
Vanessa Sheppard, PhDPrincipal InvestigatorVirginia Commonwealth University
2 Previous Clinical Trials
152 Total Patients Enrolled