Engagement of Veterans With Lung Cancer

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07219251
• Lead Sponsor: Palo Alto Veterans Institute for Research

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).

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-02
• Study First Submitted QC: 2025-10-17
• Last Update Submitted: 2025-10-17
• Study First Posted: 2025-10-21
• Last Update Posted: 2025-10-21
• Study Start: 2025-10-25
• Primary Completion: 2030-12-31
• Study Completion: 2032-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 194

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Health-Related Quality of Life	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 Outcome Measures

Name	Time	Method
Emergency Department Visits (Self-reported and Chart Review)	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.
Hospitalization Visits (Self-reported and Chart Review)	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.
Patient Activation Measure (PAM-10).	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 .
Patient-reported anxiety and depression	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
Documentation of goals of care discussions (Chart Review)	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.
Palliative Care Use (Self-reported and Chart Review)	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.
Hospice Care Use (Self-reported and Chart Review)	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.

Trial Locations

Locations (1)

Veterans Affairs Palo Alto Health Care System (VAPAHCS); 🇺🇸 Palo Alto, California, United States