Strengthening Awareness and Community Resources for Early Detection of Lung Cancer Through Navigation Guided Screening Trial (SACRED LUNGS Aims 1.2-3)
Tailored navigation to boost lung cancer screening in tribal communities
Plain English Summary
Tailored Patient Navigation to Improve the Uptake of Lung Cancer Screening in Tribal Communities in Western Washington State, SACRED LUNGS Trial is a Not Applicable clinical trial sponsored by Fred Hutchinson Cancer Center studying Lung Carcinoma. This trial tests if personalized help, called patient navigation, can increase lung cancer screening for American Indian and Alaska Native people in western Washington. It is for individuals aged 50-77 who have a history of smoking and are part of or connected to the Muckleshoot or South Puget Intertribal Planning Agency communities. Participants will either receive standard care with educational materials or standard care plus dedicated patient navigation to help them through the screening process. Alternatives include standard lung cancer screening protocols without dedicated navigation support. The trial aims to enroll 237 participants.
Official Summary
This clinical trial studies whether tailored patient navigation (PN) works to improve the uptake of lung cancer screening (LCS) in tribal communities in western Washington state. Lung cancer is the leading cause of cancer death in the United States among American Indian (AI) and Alaska Native (AN) people, and the incidence of lung cancer is higher in this population in the Northern and Southern Plains, Alaska, and Pacific Coast regions. In Washington state, AI/AN people also have twice the rate of commercial cigarette smoking than the overall population. LCS with annual low-dose chest computed tomography (CT) can reduce lung cancer death and is recommended in people 50-80 years of age with current or recent (within 15 years) tobacco use and a 20 pack-year or greater smoking history. Despite this, AI and AN people are less likely to receive LCS which may be due to barriers they face making it difficult to receive LCS. PN services are designed to guide a patient through the healthcare system and reduce barriers to timely screening, follow-up, diagnosis, treatment, and supportive care. The PN services in this trial have been tailored for the tribal communities in western Washington state. The services are designed to help participants overcome the unique barriers that their tribal communities face and improve the uptake of LCS.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are between 50-77 years old and have smoked at least 20 packs a day, quitting within the last 15 years. You must have seen a primary care doctor at a participating clinic (Muckleshoot or SPIPA) in the last three years, or be willing to establish care. You cannot join if you've had a chest CT scan in the past year or have a history of lung cancer or symptoms. Other parts of the study involve staff and patients who have already participated in the main screening part. This trial is studying Lung Carcinoma, so participants generally need a confirmed diagnosis.
What They're Measuring
The main goal is to see if more people complete a lung cancer screening CT scan within six months when they receive personalized navigation assistance. The specific primary outcome measures are: Completion of chest computed tomography (CT) (Aim 1.2) (Up to 6 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial addresses the critical gap in lung cancer screening for Native American communities, who face higher rates of lung cancer and lower screening rates, by providing culturally tailored support This research targets Lung Carcinoma, where improved treatment options are needed.
Investor Insight
This trial targets a specific, underserved population with a high need for lung cancer screening, potentially leading to improved outcomes and a model for similar community-based interventions.
Is This Trial Right for Me?
Ask your doctor if lung cancer screening is right for you, especially given your smoking history. Understand that patient navigation is designed to help you overcome barriers to getting screened, like scheduling appointments or understanding the process. Day-to-day involvement will focus on attending appointments for screening and potentially participating in surveys or interviews if you are part of those study arms. The trial is being conducted at 2 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: SINGLE
- Enrollment: 237 participants
Interventions
- BEHAVIORAL: Patient Navigation — Receive tailored PN activities
- OTHER: Educational Intervention — Receive LCS educational handout
- OTHER: Best Practice — Receive enhanced usual care
- OTHER: Interview — Ancillary studies
- OTHER: Survey Administration — Ancillary studies
Primary Outcomes
- Completion of chest computed tomography (CT) (Aim 1.2) (Up to 6 months)
Secondary Outcomes
- Completion of low dose computed tomography of the chest (Aim 1.2) (Up to 21 months)
- Lung cancer screening (LCS) knowledge (Aim 1.2) (At 21 months)
- Health-related quality of life (Aim 1.2) (At 21 months)
- Rate of reported 30-day cessation period (Aim 1.2) (Up to 6 months)
- Completion of chest CT (Aim 2) (Up to 6 months)
Full Eligibility Criteria
Inclusion Criteria: * AIM 1.2 RANDOMIZED CONTROLLED TRIAL: Between ages 50-77 * AIM 1.2 RANDOMIZED CONTROLLED TRIAL: Self-reported 20-pack year smoking history * AIM 1.2 RANDOMIZED CONTROLLED TRIAL: Ongoing commercial tobacco use within the past 15 years * AIM 1.2 RANDOMIZED CONTROLLED TRIAL: Seen by a PCP at a participating clinic (South Puget Intertribal Planning Agency \[SPIPA\] or Muckleshoot) within the past three years * Potential participants who want to establish care at an eligible clinic will be connected to a PCP * AIM 2 CLINICAL STAFF SURVEYS AND SEMI-STRUCTURED INTERVIEWS: At least 18 years of age * AIM 2 CLINICAL STAFF SURVEYS AND SEMI-STRUCTURED INTERVIEWS: Affiliation with Muckleshoot or SPIPA (one of the 6 community partnering clinics) as a provider, or supportive staff member * AIM 2 PATIENT SURVEYS AND SEMI-STRUCTURED INTERVIEWS: Patient participated in the aim 1.2 trial * AIM 3 CLINICAL STAFF SURVEYS AND SEMI-STRUCTURED INTERVIEWS: At least 18 years of age * AIM 3 CLINICAL STAFF SURVEYS AND SEMI-STRUCTURED INTERVIEWS: Affiliation with Muckleshoot or SPIPA (one of the 6 community partnering clinics) as a provider, or supportive staff member * AIM 3 PATIENT SURVEYS AND SEMI-STRUCTURED INTERVIEWS: Patient participated in the aim 1.2 trial Exclusion Criteria: * AIM 1.2 RANDOMIZED CONTROLLED TRIAL: Has had a documented chest CT within the past one year * AIM 1.2 RANDOMIZED CONTROLLED TRIAL: Personal history of lung cancer or symptoms associated with lung cancer
Trial Locations
- Muckleshoot Tribal Clinic, Auburn, Washington, United States
- South Puget Intertribal Planning Agency (SPIPA), Shelton, Washington, United States
Frequently Asked Questions
What is clinical trial NCT07176000?
NCT07176000 is a Not Applicable INTERVENTIONAL study titled "Tailored Patient Navigation to Improve the Uptake of Lung Cancer Screening in Tribal Communities in Western Washington State, SACRED LUNGS Trial." It is currently not yet recruiting and is sponsored by Fred Hutchinson Cancer Center. The trial targets enrollment of 237 participants.
What conditions does NCT07176000 study?
This trial investigates treatments for Lung Carcinoma. The primary condition under study is Lung Carcinoma.
What treatments are being tested in NCT07176000?
The interventions being studied include: Patient Navigation (BEHAVIORAL), Educational Intervention (OTHER), Best Practice (OTHER), Interview (OTHER), Survey Administration (OTHER). Receive tailored PN activities
What does Not Applicable mean for NCT07176000?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07176000?
This trial is currently "Not Yet Recruiting." It started on 2026-06-01. The estimated completion date is 2029-04-30.
Who is sponsoring NCT07176000?
NCT07176000 is sponsored by Fred Hutchinson Cancer Center. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07176000?
The trial aims to enroll 237 participants. The trial has not yet started recruiting.
How is NCT07176000 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs single masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT07176000?
The primary outcome measures are: Completion of chest computed tomography (CT) (Aim 1.2) (Up to 6 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07176000 being conducted?
This trial is being conducted at 2 sites, including Auburn, Washington; Shelton, Washington (United States).
Where can I find official information about NCT07176000?
The official record for NCT07176000 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07176000. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07176000 testing in simple terms?
This trial tests if personalized help, called patient navigation, can increase lung cancer screening for American Indian and Alaska Native people in western Washington. It is for individuals aged 50-77 who have a history of smoking and are part of or connected to the Muckleshoot or South Puget Intertribal Planning Agency communities.
Why is this trial significant?
This trial addresses the critical gap in lung cancer screening for Native American communities, who face higher rates of lung cancer and lower screening rates, by providing culturally tailored support
What are the potential risks of participating in NCT07176000?
The primary risk is related to the CT scan itself, which involves a small amount of radiation. Potential side effects from the CT scan are generally minimal, but it's important to discuss any concerns with your doctor. Some participants in other study arms may be asked to complete surveys or interviews, which involves time and personal reflection. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07176000?
Ask your doctor if lung cancer screening is right for you, especially given your smoking history. Understand that patient navigation is designed to help you overcome barriers to getting screened, like scheduling appointments or understanding the process. Day-to-day involvement will focus on attending appointments for screening and potentially participating in surveys or interviews if you are part of those study arms. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07176000 signal from an investment perspective?
This trial targets a specific, underserved population with a high need for lung cancer screening, potentially leading to improved outcomes and a model for similar community-based interventions. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will either receive standard care with educational materials or standard care plus dedicated patient navigation to help them through the screening process. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Lung Carcinoma Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.