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NCT Number: NCT07219251

Engagement of Veterans With Lung Cancer

This research study will help our understanding of whether additional support for Veterans with lung cancer can improve their quality of life.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • no capacity to consent;
  • actively receiving hospice care

Treatment and study plan

Lay Health Worker (LHW) Planning

Behavioral

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 Group

Other

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.

Other names: Usual Care

Primary outcomes

  1. 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.

Secondary outcomes

  1. Emergency Department Visits (Self-reported and Chart Review)

    Time frame: From baseline (time of enrollment) to 12 Months post-enrollment

    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.

  2. Hospitalization Visits (Self-reported and Chart Review)

    Time frame: From baseline (time of enrollment) to 12 months post-enrollment

    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.

  3. Patient Activation Measure (PAM-10).

    Time frame: At baseline (time of enrollment), 3, 6, 9 and 12 months post-enrollment

    Change in patient activation using 10-item validated survey Patient Activation Measure (PAM-10) assessing patient activation in their health and health care .

  4. Patient-reported anxiety and depression

    Time frame: At baseline, 3, 6, 9 and 12 months post-enrollment

    Patient-reported anxiety and depression using the validated Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety and Depression scales

  5. Documentation of goals of care discussions (Chart Review)

    Time frame: At baseline, 3, 6, 9 and 12 months post-enrollment

    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.

  6. Palliative Care Use (Self-reported and Chart Review)

    Time frame: From baseline (time of enrollment) to 12 months post-enrollment

    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.

  7. Hospice Care Use (Self-reported and Chart Review)

    Time frame: From baseline (time of enrollment) to 12 months post-enrollment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Madhuri Agrawal, MS

CONTACT

[email protected]

650-304-7744

Manali I Patel, MD MPH MS

CONTACT

[email protected]

6504935000

Sponsors and collaborators

Lead sponsor

Palo Alto Veterans Institute for Research

Other

Collaborators

  • US Department of Veterans Affairs
  • United States Department of Defense

Registry information

Official study title

Engagement of Veterans With Lung Cancer (EVLC)

Acronym: EVLC

Important dates

Study start
2026
Primary completion
2030
Study completion
2032
First posted
Oct 21, 2025
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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