Patient Navigation for Lung Cancer Screening
(HEALS Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Virginia Commonwealth University
Disqualifiers: Cancer history, Hemoptysis, Non-English, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Evaluate the impact of the patient navigation program on the proportion of patients who complete lung cancer screening (LCS), defined as undergoing a low dose computed tomography (LDCT)
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Patient Navigation for Lung Cancer Screening?
Research shows that patient navigation programs can improve cancer screening rates and quality of life for cancer patients, especially in underserved populations. These programs help ensure patients receive timely care and support, which can lead to better health outcomes.
12345Is patient navigation safe for humans?
Patient navigation has been used safely in various healthcare settings to help people access cancer care and screenings. It has been shown to improve access to timely care without any reported safety concerns.
34678How does patient navigation differ from other treatments for lung cancer?
Patient navigation is unique because it focuses on guiding patients through the healthcare system, ensuring timely access to screenings, treatments, and support, especially for vulnerable populations. Unlike traditional treatments that directly target the cancer, patient navigation helps improve overall care coordination and patient satisfaction by addressing barriers to care.
378910Eligibility Criteria
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.Inclusion Criteria
I am a current smoker or quit smoking within the last 15 years.
Meets current USPSTF guidelines for lung cancer screening (LCS)
I am willing to participate in all required study activities.
+3 more
Exclusion Criteria
I cannot speak English.
I have not had cancer (except skin cancer), COPD, emphysema, or coughed up blood in the last 5 years.
Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Patient Navigation Intervention
Centralized patient navigators help patients navigate the clinical, logistical, and financial aspects of lung cancer screening (LCS).
2 weeks to 4 months
Varies by participant
Follow-up
Participants are monitored for health-related quality of life and satisfaction with the navigation program.
2 weeks to 4 months
Participant Groups
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Medical University of South CarolinaCharleston, SC
University of North Carolina-Chapel HillCarrboro, NC
Virginia Commonwealth UniversityRichmond, VA
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Who Is Running the Clinical Trial?
Virginia Commonwealth UniversityLead Sponsor
Stand Up To CancerCollaborator
References
Satisfaction With Health Care Among Patients Navigated for Preventive Cancer Screening. [2022]Patient navigation (PN) programs can improve cancer screening in underserved populations. PN may advance quality and equity of care by supporting individuals at increased risk of not receiving recommended care.
Randomized controlled trial of patient navigation for newly diagnosed cancer patients: effects on quality of life. [2021]Patient navigation is a promising intervention to ameliorate cancer health disparities. This study objective was to measure patient navigation effects on cancer-specific quality of life (QOL) among patients with newly diagnosed cancer.
Cost-Effectiveness Analysis of a Capitated Patient Navigation Program for Medicare Beneficiaries with Lung Cancer. [2022]To assess the cost-effectiveness of implementing a patient navigation (PN) program with capitated payment for Medicare beneficiaries diagnosed with lung cancer.
Beneficial effects of a combined navigator/promotora approach for Hispanic women diagnosed with breast abnormalities. [2021]Patient navigation (PN) is an emerging strategy to overcome barriers to cancer care. We evaluated the efficacy of PN in improving time of key events in cancer care, including positive screening tests, definitive diagnosis, initiation of therapy, and completion of initial therapy.
Measuring the impact and potential of patient navigation: proposed common metrics and beyond. [2021]In March 2010, the American Cancer Society hosted the National Patient Navigation Leadership Summit. The Summit organizers invited cancer clinicians, researchers, practicing public health and measurement experts, funders, and patient navigators to develop a national consensus on common outcomes to solidify the scientific evidence and efficacy of patient navigation. The goal of the Summit was to develop and propose core metrics to measure outcomes of navigation on individuals as well as populations across the continuum. It is the sincere hope of the editors, funders, authors, and workgroup members that this supplement and the proposed measures provide a roadmap for the development, implementation,and evaluation of patient navigation programs.
Patient navigation for lung cancer screening among current smokers in community health centers a randomized controlled trial. [2019]Annual chest computed tomography (CT) can decrease lung cancer mortality in high-risk individuals. Patient navigation improves cancer screening rates in underserved populations. Randomized controlled trial was conducted from February 2016 to January 2017 to evaluate the impact of a patient navigation program on lung cancer screening (LCS) among current smokers in five community health centers (CHCs) affiliated with an academic primary care network. We randomized 1200 smokers aged 55-77 years to intervention (n = 400) or usual care (n = 800). Navigators contacted patients to determine LCS eligibility, introduce shared decision making about screening, schedule appointments with primary care physicians (PCPs), and help overcome barriers to obtaining screening and follow-up. Control patients received usual care. The main outcome was the proportion of patients who had any chest CT. Secondary outcomes were the proportion of patients contacted, proportion receiving LCS CTs, screening results and number of lung cancers diagnosed. Of the 400 intervention patients, 335 were contacted and 76 refused participation. Of the 259 participants, 124 (48%) were ineligible for screening; 119 had smoked
Integration of a nurse navigator into the triage process for patients with non-small-cell lung cancer: creating systematic improvements in patient care. [2018]Nurse navigation is a developing facet of oncology care. The concept of patient navigation was originally created in 1990 at the Harlem Hospital Center in New York City as a strategy to assist vulnerable and socially disadvantaged populations with timely access to breast cancer care. Since the mid-1990s, navigation programs have expanded to include many patient populations that require specialized management and prompt access to diagnostic and clinical resources. Advanced non-small-cell lung cancer is ideally suited for navigation to facilitate efficient assessment in this fragile patient population and to ensure timely results of molecular tests for first-line therapy with appropriately targeted agents. At the BC Cancer Agency, nurse navigator involvement with thoracic oncology triage has been demonstrated to increase the proportion of patients receiving systemic treatment, to shorten the time to delivery of systemic treatment, and to increase the rate of molecular testing and the number of patients with molecular testing results available at time of initial consultation. Insights gained through the start-up process are briefly discussed, and a framework for implementation at other institutions is outlined.
The Case for Patient Navigation in Lung Cancer Screening in Vulnerable Populations: A Systematic Review. [2020]Patient navigation has been proposed to combat cancer disparities in vulnerable populations. Vulnerable populations often have poorer cancer outcomes and lower levels of screening, adherence, and treatment. Navigation has been studied in various cancers, but few studies have assessed navigation in lung cancer. Additionally, there is a lack of consistency in metrics to assess the quality of navigation programs. The authors conducted a systematic review of published cancer screening studies to identify quality metrics used in navigation programs, as well as to recommend standardized metrics to define excellence in lung cancer navigation. The authors included 26 studies evaluating navigation metrics in breast, cervical, colorectal, prostate, and lung cancer. After reviewing the literature, the authors propose the following navigation metrics for lung cancer screening programs: (1) screening rate, (2) compliance with follow-up, (3) time to treatment initiation, (4) patient satisfaction, (5) quality of life, (6) biopsy complications, and (7) cultural competency.
Satisfaction with cancer care among underserved racial-ethnic minorities and lower-income patients receiving patient navigation. [2022]Patient navigation is a barrier-focused program of care coordination designed to achieve timely and high-quality cancer-related care for medically underserved racial-ethnic minorities and the poor. However, to the authors' knowledge, few studies to date have examined the relationship between satisfaction with navigators and cancer-related care.
Implementation of evidence-based patient navigation programs. [2017]Patient navigation refers to a direct patient care role that links patients with clinical providers and their support system and provides individualized support during cancer care, ensuring that patients have access to the knowledge and resources necessary to complete recommended treatment. While most reports have studied the role of patient navigators during the cancer screening or diagnostic process, emerging evidence indicates the benefits of patient navigation during active cancer treatment.