Engagement of Veterans With Lung Cancer (EVLC)

Palo Alto Veterans Institute for Research

Status: Not yet enrolling

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

Treatments: Behavioral: Lay Health Worker (LHW) Planning; Other: Usual Care Group

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT07219251

IRB-79923

LC240650 (Other Grant/Funding Number)

Details and patient eligibility

About

This research study will help our understanding of whether additional support for Veterans with lung cancer can improve their quality of life.

Full 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).

Enrollment: 194 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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194 participants in 2 patient groups

Usual Care - Arm A

Active Comparator group

Description:

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

Treatment:

Other: Usual Care Group

Intervention Lay Health Worker (LHW) - Arm B

Experimental group

Description:

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.

Treatment:

Behavioral: Lay Health Worker (LHW) Planning