Engagement of Veterans With Lung Cancer

NCT07219251 | Recruiting

• 2 other identifiers: IRB-79923LC240650
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

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, Non-Small Cell; Lung Carcinoma; Lung Cancer, Small Cell; Lung Adenocarcinoma With Bronchiolo-alveolar Feature; Lung Cancer (NSCLC); Lung Adenocarcinoma

Keywords

lung; cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  At Baseline (time of enrollment), 3, 6, 9, and 12 months post-enrollment

Secondary Outcomes (7)

• Emergency Department Visits (Self-reported and Chart Review)

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

• Hospitalization Visits (Self-reported and Chart Review)

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

• Patient Activation Measure (PAM-10).

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

• Patient-reported anxiety and depression

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

• Documentation of goals of care discussions (Chart Review)

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

Study Arms (2)

Usual Care - Arm A

ACTIVE COMPARATOR

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

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.

Behavioral: Lay Health Worker (LHW) Planning

Interventions

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.

Intervention Lay Health Worker (LHW) - Arm B

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.

Also known as: Usual Care

Usual Care - Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veteran patients with diagnosis of any stage of lung cancer;
• 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)

You may not qualify if:

• no capacity to consent;
• actively receiving hospice care

Sponsors & Collaborators

• Palo Alto Veterans Institute for Research: lead
• United States Department of Defense: collaborator
• US Department of Veterans Affairs: collaborator

Study Sites (1)

Veterans Affairs Palo Alto Health Care System (VAPAHCS)

Palo Alto, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung; Small Cell Lung Carcinoma; Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

Manali I Patel, MD MPH MS

CONTACT

6504935000; manalip@stanford.edu

Madhuri Agrawal, MS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The statistician analyzing the data will be masked from the randomization assignment. The principal investigator overseeing the trial will have access to the data but will also be masked from randomization assignment.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Oncologist and Investigator

Model Details: intervention vs. usual care

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: October 21, 2025
• Study Start: February 27, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2032
• Last Updated: March 3, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)