Ensuring Precision-Medicine Delivery for Veterans With Lung Cancer

NCT05795959 | Completed

• 1 other identifier: 67785
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to learn if using a lay VA volunteer, who will assist patients with education regarding precision medicine, can improve care quality and outcomes for Veteran patients with lung cancer.

Conditions

Lung Cancer

Keywords

Precision Medicine; Lung Diseases; Lay health worker; Veteran health

Outcome Measures

Primary Outcomes (1)

• Knowledge of precision medicine for cancer care from time of enrollment to 1 month post-enrollment

  Using 8 multiple choice items adapted from an 8-item survey tool, Knowledge and Purpose of Molecular Profiling, by Davies et. al., 2020, we will assess knowledge of precision medicine for cancer care at time of enrollment and again at 1-month post-enrollment. For example one question asks 'tumor testing is helpful for guiding the treatment of lung cancer,' with answer choices: yes or no. Answers will be scored as number or percent correct.

  Baseline

Secondary Outcomes (6)

• Patient activation using the "Patient Activation Measure" survey

  Baseline

• Patient activation using the "Patient Activation Measure" survey

  1 month post-enrollment

• Patient Satisfaction With Shared Decision Making using the "Shared Decision Making Questionnaire" Survey

  Baseline

• Patient Satisfaction With Shared Decision Making using the "Shared Decision Making Questionnaire" Survey

  1 month post-enrollment

• Receipt of molecular testing

  6 months post-enrollment

Study Arms (2)

Intervention

EXPERIMENTAL

Participants randomized to this arm of the study will receive usual care with supplemental education and support provided by a lay VA volunteer trained on evidence-based lung cancer care.

Behavioral: Receive education on precision medicine

Control

NO INTERVENTION

Participants randomized to this arm of the study will receive usual clinical care.

Interventions

Receive education on precision medicine BEHAVIORAL

Patients who consent to participating in the study and are randomized to the intervention group, will meet 1 on 1 with a trained lay VA volunteer. The trained lay VA volunteer will conduct phone calls with patients until the end of the 1 month enrollment period to deliver education regarding precision medicine.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients 18 years old that have been newly diagnosed with any stage of lung cancer.
• Patients must have the ability to understand and willingness to provide verbal consent.
• Participants must speak English.

You may not qualify if:

• Inability to consent to the study, severe mental illness (e.g. schizophrenia) or institutionalization.
• Patients who anticipate moving care outside the Veterans Affairs Palo Alto Health Care System within 6 months.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

VA Palo Alto

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases

Study Officials

• Manali I Patel, MD MPH MS

  VA Palo Alto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: April 3, 2023
• Study Start: April 20, 2023
• Primary Completion: May 20, 2024
• Study Completion: May 20, 2024
• Last Updated: February 12, 2025

Record last verified: 2025-02

Locations

US (1)