An interventional study of Lay Health Worker (LHW) Planning and Usual Care Group in Lung Cancer (NSCLC), Lung Adenocarcinoma and Lung Cancer, Non-Small Cell, sponsored by Palo Alto Veterans Institute for Research. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-03.
Sponsored by Palo Alto Veterans Institute for Research · Not applicable, Interventional, and Health services research
This research study will help our understanding of whether additional support for Veterans with lung cancer can improve their quality of life.
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).
Exclusion Criteria:
Patients randomized to this group will receive usual care provided by their oncology(or primary) clinical team.
Other: Usual Care Group
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
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.
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
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.
Time frame: At Baseline (time of enrollment), 3, 6, 9, and 12 months post-enrollment
Emergency Department Visits (Self-reported and Chart Review)
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.
Time frame: From baseline (time of enrollment) to 12 Months post-enrollment
Hospitalization Visits (Self-reported and Chart Review)
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.
Time frame: From baseline (time of enrollment) to 12 months post-enrollment
Patient Activation Measure (PAM-10).
Change in patient activation using 10-item validated survey Patient Activation Measure (PAM-10) assessing patient activation in their health and health care .
Time frame: At baseline (time of enrollment), 3, 6, 9 and 12 months post-enrollment
Patient-reported anxiety and depression
Patient-reported anxiety and depression using the validated Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety and Depression scales
Time frame: At baseline, 3, 6, 9 and 12 months post-enrollment
Documentation of goals of care discussions (Chart Review)
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.
Time frame: At baseline, 3, 6, 9 and 12 months post-enrollment
Palliative Care Use (Self-reported and Chart Review)
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.
Time frame: From baseline (time of enrollment) to 12 months post-enrollment
Hospice Care Use (Self-reported and Chart Review)
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.
Time frame: From baseline (time of enrollment) to 12 months post-enrollment
Plan to share: No
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Palo Alto Veterans Institute for Research