Lung Cancer (NSCLC)EVLCNCT07219251
Engagement of Veterans With Lung Cancer
A study testing Lay Health Worker (LHW) Planning in people with Lung Cancer (NSCLC) and Lung Adenocarcinoma, run by Palo Alto Veterans Institute for Research at 1 site in United States.
Trial summary
This research study will help our understanding of whether additional support for Veterans with lung cancer can improve their quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer (NSCLC), Lung Adenocarcinoma, Lung Cancer, Non-Small Cell
- What is being tested?
- Lay Health Worker (LHW) Planning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2026to 31 Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran patients with diagnosis of any stage of lung cancer;
- 18 years of age or older;
- English- or Spanish-speaking;
- can self-administer questionnaires in English or Spanish;
- valid telephone number;
- receiving oncology care at participating sites;
- currently newly diagnosed or receiving or having completed systemic anti-cancer therapy and/or radiation therapy within 12 months, defined as oral, injection, or intravenous therapy (chemotherapy, targeted therapy, or immunotherapy)
Who cannot join
- no capacity to consent;
- actively receiving hospice care
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Veterans Affairs Palo Alto Health Care System (VAPAHCS)
Palo Alto, California, 94304
Madhuri Agrawal, MS, 650-304-7744, madhuri.agrawal@va.gov
About this study
Official title: Engagement of Veterans With Lung Cancer (EVLC)
This research study will help our understanding of whether additional support for Veterans with lung cancer can improve their quality of life.
Read the detailed description
This study aims to evaluate whether a lay health worker who provides education and support regarding goals of care and symptom management can improve health-related quality of life among Veterans with newly diagnosed lung cancer and those receiving treatment or who have completed treatment within 12 months as compared to usual care. We will also determine whether the intervention reduces acute care use and explore effects on anxiety and depression, patient activation, and goals of care communication. This knowledge is important as it will help to improve care for Veterans with lung cancer.
PRIMARY OBJECTIVES:
i.) Health-related quality of life
SECONDARY OBJECTIVES:
i.) acute care use ii.) patient activation iii.) anxiety and depression iv.) documentation of goals of care (GoC) v.) palliative care use vi.) hospice use
OUTLINE: The study will enroll and randomize 1:1 a total of 194 Veterans diagnosed with lung cancer (any stage).
Arm A: Participants randomized to the usual care group will receive usual care provided by their oncology clinical team.
Arm B: Participants randomized to the LHW group will receive usual care provided by their oncology clinical team and also receive weekly telephone calls with a trained lay health worker to assist with healthcare planning, symptom management, and discussions about care preferences and goals for 6 months.
All participants regardless of group randomization, will be required to complete surveys at the start of the study and at 3-month intervals for 12 months (i.e., at enrollment, 3 months, 6 months, 9 months, and 12 months).
- Conditions
- Lung Cancer (NSCLC), Lung Adenocarcinoma, Lung Cancer, Non-Small Cell, Lung Carcinoma, Lung Cancer, Small Cell, Lung Adenocarcinoma With Bronchiolo-alveolar Feature
- Being tested
- Lay Health Worker (LHW) Planning, Usual Care Group
- Keywords
- lung, cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung, Small Cell Lung Carcinoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lay Health Worker (LHW) PlanningBehavioural
Patients randomized to the LHW group will receive usual care provided by their oncology (or primary) clinical team along with an initial 30-minute telephone call with the LHW from Palo Alto, followed by weekly 15-minute phone calls (or as needed) for 6months. These calls are designed to assist with healthcare planning, symptom management, and discussions about care preferences and goals.
Usual Care GroupOther
Also called Usual Care
Participants randomized to the usual care group will receive usual care provided by their oncology clinical team. These teams have been trained in symptom assessment, goals-of-care (GoC) discussions, and documentation of such clinical services. As part of usual care, participants may engage in symptom and GoC discussions at any time, initiated by either the patient or the clinician.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care - Arm A | Active comparator | Patients randomized to this group will receive usual care provided by their oncology(or primary) clinical team. Receives: Other: Usual Care Group |
| Intervention Lay Health Worker (LHW) - Arm B | Experimental | Participants randomized to this arm of the study will receive usual care with supplemental education and support provided by a lay health worker (LHW) to assist with healthcare planning, symptom management, and discussions about care preferences and goals. Receives: Behavioral: Lay Health Worker (LHW) Planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-Related Quality of Life
Change in Health-related quality of life using the 36-item validated Functional Assessment of Cancer Therapeutics-Lung (FACT-L) survey.
Measured: At Baseline (time of enrollment), 3, 6, 9, and 12 months post-enrollment
Secondary outcomes (7)
Emergency Department Visits (Self-reported and Chart Review)
Emergency Department use will be self-reported by each patient or abstracted by electronic medical record at 3, 6, 9 and 12 months after enrollment.
Measured: From baseline (time of enrollment) to 12 Months post-enrollment
Hospitalization Visits (Self-reported and Chart Review)
Hospital use for each patient will be self-reported by each patient or abstracted by electronic medical record at 3, 6, 9 and 12 months after enrollment.
Measured: From baseline (time of enrollment) to 12 months post-enrollment
Patient Activation Measure (PAM-10).
Change in patient activation using 10-item validated survey Patient Activation Measure (PAM-10) assessing patient activation in their health and health care .
Measured: At baseline (time of enrollment), 3, 6, 9 and 12 months post-enrollment
Patient-reported anxiety and depression
Patient-reported anxiety and depression using the validated Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety and Depression scales
Measured: At baseline, 3, 6, 9 and 12 months post-enrollment
Documentation of goals of care discussions (Chart Review)
Documentation of goals of care discussions will be abstracted by electronic medical record chart review for each patient at 3, 6, 9 and 12 months after enrollment.
Measured: At baseline, 3, 6, 9 and 12 months post-enrollment
Palliative Care Use (Self-reported and Chart Review)
Palliative care use will be self-reported by each patient or abstracted by electronic medical record at 3, 6, 9 and 12 months after patient enrollment.
Measured: From baseline (time of enrollment) to 12 months post-enrollment
Hospice Care Use (Self-reported and Chart Review)
Hospice care use will be self-reported by each patient or abstracted by electronic medical record at 3, 6, 9 and 12 months after patient enrollment.
Measured: From baseline (time of enrollment) to 12 months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2025
- Study start27 Feb 2026
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- intervention vs. usual care
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Palo Alto Veterans Institute for Research
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, US Department of Veterans Affairs
- Responsible party
- Principal investigator, Manali Patel, VA Palo Alto Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219251
- Sponsor's protocol ID
- IRB-79923
- Other IDs
- LC240650
- Acronym
- EVLC
- Status last verified
- Mar 2026
- First submitted
- 2 Oct 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engagement of Veterans With Lung Cancer (EVLC)
- ClinicalTrials.gov ID
- NCT07219251
- Acronym / sponsor ID
- EVLC / IRB-79923
- Conditions
- Lung Cancer (NSCLC), Lung Adenocarcinoma, Lung Cancer, Non-Small Cell, Lung Carcinoma, Lung Cancer, Small Cell, Lung Adenocarcinoma With Bronchiolo-alveolar Feature
- Keywords
- lung, cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Palo Alto Veterans Institute for ResearchUniversity, hospital or other
- Collaborators
- United States Department of Defense, US Department of Veterans Affairs
- Study start
- 27 Feb 2026 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 21 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study will help our understanding of whether additional support for Veterans with lung cancer can improve their quality of life.
Detailed description
This study aims to evaluate whether a lay health worker who provides education and support regarding goals of care and symptom management can improve health-related quality of life among Veterans with newly diagnosed lung cancer and those receiving treatment or who have completed treatment within 12 months as compared to usual care. We will also determine whether the intervention reduces acute care use and explore effects on anxiety and depression, patient activation, and goals of care communication. This knowledge is important as it will help to improve care for Veterans with lung cancer.
PRIMARY OBJECTIVES:
i.) Health-related quality of life
SECONDARY OBJECTIVES:
i.) acute care use ii.) patient activation iii.) anxiety and depression iv.) documentation of goals of care (GoC) v.) palliative care use vi.) hospice use
OUTLINE: The study will enroll and randomize 1:1 a total of 194 Veterans diagnosed with lung cancer (any stage).
Arm A: Participants randomized to the usual care group will receive usual care provided by their oncology clinical team.
Arm B: Participants randomized to the LHW group will receive usual care provided by their oncology clinical team and also receive weekly telephone calls with a trained lay health worker to assist with healthcare planning, symptom management, and discussions about care preferences and goals for 6 months.
All participants regardless of group randomization, will be required to complete surveys at the start of the study and at 3-month intervals for 12 months (i.e., at enrollment, 3 months, 6 months, 9 months, and 12 months).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- intervention vs. usual care
| Arm | Type | Receives |
|---|---|---|
| Usual Care - Arm A | Active comparator | Other: Usual Care GroupPatients randomized to this group will receive usual care provided by their oncology(or primary) clinical team. |
| Intervention Lay Health Worker (LHW) - Arm B | Experimental | Behavioral: Lay Health Worker (LHW) PlanningParticipants randomized to this arm of the study will receive usual care with supplemental education and support provided by a lay health worker (LHW) to assist with healthcare planning, symptom management, and discussions about care preferences and goals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Veteran patients with diagnosis of any stage of lung cancer;
- 18 years of age or older;
- English- or Spanish-speaking;
- can self-administer questionnaires in English or Spanish;
- valid telephone number;
Key exclusion criteria (2 listed)
- no capacity to consent;
- actively receiving hospice care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lay Health Worker (LHW) PlanningPatients randomized to the LHW group will receive usual care provided by their oncology (or primary) clinical team along with an initial 30-minute telephone call with the LHW from Palo Alto, followed by weekly 15-minute phone calls (or as needed) for 6months. These calls are designed to assist with healthcare planning, symptom management, and discussions about care preferences and goals. | Behavioural | Intervention Lay Health Worker (LHW) - Arm B |
| Usual Care GroupAlso: Usual CareParticipants randomized to the usual care group will receive usual care provided by their oncology clinical team. These teams have been trained in symptom assessment, goals-of-care (GoC) discussions, and documentation of such clinical services. As part of usual care, participants may engage in symptom and GoC discussions at any time, initiated by either the patient or the clinician. | Other | Usual Care - Arm A |
Primary outcome
Health-Related Quality of Life
Time frame: At Baseline (time of enrollment), 3, 6, 9, and 12 months post-enrollment
Change in Health-related quality of life using the 36-item validated Functional Assessment of Cancer Therapeutics-Lung (FACT-L) survey.
7 secondary outcomes
Emergency Department Visits (Self-reported and Chart Review)
Time frame: From baseline (time of enrollment) to 12 Months post-enrollment
Hospitalization Visits (Self-reported and Chart Review)
Time frame: From baseline (time of enrollment) to 12 months post-enrollment
Patient Activation Measure (PAM-10).
Time frame: At baseline (time of enrollment), 3, 6, 9 and 12 months post-enrollment
Patient-reported anxiety and depression
Time frame: At baseline, 3, 6, 9 and 12 months post-enrollment
Documentation of goals of care discussions (Chart Review)
Time frame: At baseline, 3, 6, 9 and 12 months post-enrollment
Palliative Care Use (Self-reported and Chart Review)
Time frame: From baseline (time of enrollment) to 12 months post-enrollment
Hospice Care Use (Self-reported and Chart Review)
Time frame: From baseline (time of enrollment) to 12 months post-enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lay Health Worker (LHW) Planning in people with Lung Cancer (NSCLC) and Lung Adenocarcinoma, run by Palo Alto Veterans Institute for Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manali I Patel, MD MPH MS (6504935000, manalip@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-Related Quality of Life (time frame: At Baseline (time of enrollment), 3, 6, 9, and 12 months post-enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.