Recruiting

Observational Study

Sponsor:

Palo Alto Veterans Institute for Research

Code:

NCT07219251

Conditions

Lung Cancer (NSCLC)

Lung Adenocarcinoma

Lung Cancer, Non-Small Cell

Lung Carcinoma

Lung Cancer, Small Cell

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lay Health Worker (LHW) Planning

Usual Care Group

Study Details

Brief summary:

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

Conditions

Lung Cancer (NSCLC)

Lung Adenocarcinoma

Lung Cancer, Non-Small Cell

Lung Carcinoma

Lung Cancer, Small Cell

Study ID

NCT07219251

Start date

Feb 27, 2026

Status verified date

Mar, 2026

Completion date

Dec 31, 2032

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Veteran patients with diagnosis of any stage of lung cancer;
2. 18 years of age or older;
3. English- or Spanish-speaking;
4. can self-administer questionnaires in English or Spanish;
5. valid telephone number;
6. receiving oncology care at participating sites;
7. 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:

1. no capacity to consent;
2. actively receiving hospice care

Study Design

Enrollment

194 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Usual Care - Arm A

Patients randomized to this group will receive usual care provided by their oncology(or primary) clinical team.

experimental: Intervention Lay Health Worker (LHW) - Arm B

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.

Interventions

Lay Health Worker (LHW) Planning

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

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.

Primary outcome measure

  • Health-Related Quality of Life [ Time Frame: At Baseline (time of enrollment), 3, 6, 9, and 12 months post-enrollment ]

Central Contacts and Locations

Central contacts

Manali I Patel, MD MPH MS

6504935000manalip@stanford.edu

Madhuri Agrawal, MS

650-304-7744madhuri.agrawal@va.gov

Locations

Veterans Affairs Palo Alto Health Care System (VAPAHCS)

Recruiting

Palo Alto, California, United States, 94304

Contacts

Madhuri Agrawal, MS

650-304-7744madhuri.agrawal@va.gov

More Information

Sponsor

Palo Alto Veterans Institute for Research

Last update posted

Mar 3, 2026

Last verified

Mar, 2026

Keywords

  • lung
  • cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Palo Alto Veterans Institute for Research on 2026-03-03.