Engagement of Veterans With Lung Cancer

NCT ID: NCT07219251

Last Updated: 2025-10-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 194 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-25
• Study Completion Date: 2032-12-31

Brief Summary

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).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

Usual Care - Arm A

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

Group Type: ACTIVE_COMPARATOR

Usual Care Group

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Lay Health Worker (LHW) Planning

Intervention Type: 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.

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Other Intervention Names

Usual Care

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

US Department of Veterans Affairs

FED

Sponsor Role: collaborator

Palo Alto Veterans Institute for Research

OTHER

Sponsor Role: lead

Responsible Party

Manali Patel

Staff Oncologist and Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Veterans Affairs Palo Alto Health Care System (VAPAHCS)

Palo Alto, California, United States

Countries

United States

Central Contacts

Manali I Patel, MD MPH MS

Role: CONTACT

manalip@stanford.edu

6504935000

Madhuri Agrawal, MS

Role: CONTACT

madhuri.agrawal@va.gov

650-304-7744

Facility Contacts

Madhuri Agrawal, MS

Role: primary

madhuri.agrawal@va.gov

650-304-7744

Other Identifiers

LC240650

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB-79923

Identifier Type: -

Identifier Source: org_study_id