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Engagement of Veterans With Lung Cancer

ConditionsLung Cancer (NSCLC)Lung AdenocarcinomaLung Cancer, Non-Small CellLung CarcinomaLung Cancer, Small CellLung Adenocarcinoma With Bronchiolo-alveolar Feature
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPalo Alto Veterans Institute for Research

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

no capacity to consent;

actively receiving hospice care

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lay Health Worker (LHW) Planning

    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.

  • Usual Care Group

    Other intervention

    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.

Treatment groups

194 Participants
are divided into 2 treatment groups
Group A: Usual Care - Arm AActive comparator 1 intervention
Group B: Intervention Lay Health Worker (LHW) - Arm BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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Palo Alto Veterans Institute for Research

Lead sponsor

VA Palo Alto Health Care System

Sponsor institution

United States Department of Defense

Collaborator

US Department of Veterans Affairs

Collaborator

Source ClinicalTrials.gov
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