Engagement of Veterans With Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lay Health Worker (LHW) Planning, Usual Care Group.
- Who it may be relevant to
- Registry conditions: Lung Cancer (NSCLC), Lung Adenocarcinoma, Lung Cancer, Non-Small Cell, Lung Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Engagement of Veterans With Lung Cancer (EVLC)
Overview
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).
Interventions
- 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. - Other 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 measures
- Health-Related Quality of Life [Time frame: At Baseline (time of enrollment), 3, 6, 9, and 12 months post-enrollment]
Secondary outcome measures (7)
- Emergency Department Visits (Self-reported and Chart Review) [Time frame: From baseline (time of enrollment) to 12 Months post-enrollment]
- Hospitalization Visits (Self-reported and Chart Review) [Time frame: From baseline (time of enrollment) to 12 months post-enrollment]
- Patient Activation Measure (PAM-10). [Time frame: At baseline (time of enrollment), 3, 6, 9 and 12 months post-enrollment]
- Patient-reported anxiety and depression [Time frame: At baseline, 3, 6, 9 and 12 months post-enrollment]
- Documentation of goals of care discussions (Chart Review) [Time frame: At baseline, 3, 6, 9 and 12 months post-enrollment]
- Palliative Care Use (Self-reported and Chart Review) [Time frame: From baseline (time of enrollment) to 12 months post-enrollment]
- Hospice Care Use (Self-reported and Chart Review) [Time frame: From baseline (time of enrollment) to 12 months post-enrollment]
Eligibility criteria
Inclusion criteria
- Veteran patients with diagnosis of any stage of lung cancer;
- 18 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)
Exclusion criteria
- no capacity to consent;
- actively receiving hospice care
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Veterans Affairs Palo Alto Health Care System (VAPAHCS) — Palo Alto
Identifiers
NCT: NCT07219251 · IRB-79923 · LC240650