Back to resultsEnsuring Precision-Medicine Delivery for Veterans With Lung Cancer
Primary Purpose
Lung Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Receive education on precision medicine
Sponsored by
About this trial
This is an interventional health services research trial for Lung Cancer focused on measuring Precision Medicine, Lung Diseases, Lay health worker, Veteran health
Eligibility Criteria
Inclusion Criteria: All patients >18 years old that have been diagnosed with any stage of lung cancer within the past 8 months are eligible for this study. Patients must have the ability to understand and willingness to provide verbal consent. Participants must speak English. Exclusion Criteria: Inability to consent to the study, severe mental illness (e.g. schizophrenia) or institutionalization. Patients who anticipate moving from the area within 6 months.
Sites / Locations
- VA Palo AltoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
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.
Participants randomized to this arm of the study will receive usual clinical care.
Outcomes
Primary Outcome Measures
Knowledge of precision medicine for cancer care from time of enrollment to 1 month post-enrollment
Using 7 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.
Secondary Outcome Measures
Patient activation using the "Patient Activation Measure" survey
Each patient will receive a validated patient activation survey using the "Patient Activation Measure" at baseline. This is a validated measure from Insignia Health. Responses are: disagree strongly, disagree, agree, agree strongly with higher activation correlated with responses of agree and agree strongly. Each item is rated on 4-point scale (1 strongly disagree to 4 strongly agree, with additional "not applicable" option). Higher scores indicate greater patient activation. For the PAM-10, minimum score is 0 (if all not-applicable) and maximum is 40. Raw scores are converted into activation levels per the scoring guidelines by Insignia Health for: level 1 Disengaged and Overwhelmed, level 2 Becoming Aware but Still Struggling, level 3 Taking Action and Gaining Control, level 4 Maintaining "Behaviors and Pushing Further. Scores for each group will be averaged at baseline.
Patient activation using the "Patient Activation Measure" survey
Each patient will receive a validated patient activation survey using the "Patient Activation Measure" at 1 month post-enrollment. This is a validated measure from Insignia Health. Responses are: disagree strongly, disagree, agree, agree strongly with higher activation correlated with responses of agree and agree strongly. Each item is rated on 4-point scale (1 strongly disagree to 4 strongly agree, with additional "not applicable" option). Higher scores indicate greater patient activation. For the PAM-10, minimum score is 0 (if all not-applicable) and maximum is 40. Raw scores are converted into activation levels per the scoring guidelines by Insignia Health for: level 1 Disengaged and Overwhelmed, level 2 Becoming Aware but Still Struggling, level 3 Taking Action and Gaining Control, level 4 Maintaining "Behaviors and Pushing Further. Scores for each group will be averaged at 1 month post-enrollment
Patient Satisfaction With Shared Decision Making using the "Shared Decision Making Questionnaire" Survey
Using 7 items of the validated 9-item Shared Decision Making Questionnaire (SDM-Q-9) at baseline. Responses are "completely disagree, strongly disagree, somewhat disagree, somewhat agree, strongly agree, or completely agree," with 1=completely disagree and 6= completely agree. Higher scores indicate greater levels of satisfaction.
Patient Satisfaction With Shared Decision Making using the "Shared Decision Making Questionnaire" Survey
Using 7 items of the validated 9-item Shared Decision Making Questionnaire (SDM-Q-9) at 1 month post-enrollment. Responses are "completely disagree, strongly disagree, somewhat disagree, somewhat agree, strongly agree, or completely agree," with 1=completely disagree and 6= completely agree. Higher scores indicate greater levels of satisfaction.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05795959
Brief Title
Ensuring Precision-Medicine Delivery for Veterans With Lung Cancer
Official Title
Ensuring Precision-Medicine Delivery for Veterans With Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2023 (Actual)
Primary Completion Date
April 20, 2024 (Anticipated)
Study Completion Date
April 20, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Participants in the intervention group will receive 1:1 communication with a lay VA volunteer in addition to their usual clinical care. The lay VA volunteer will provide patients with education about precision medicine and support in their care. Researchers will compare a control group who will receive their usual oncology care as provided by clinical teams at the VA. There will be no change in their care.
All participants will be asked to complete a survey at the time of enrollment in the study, and also at 1 month. This survey will measure patient participation in their cancer care, satisfaction with healthcare decisions, and overall questions about knowledge of precision medicine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Precision Medicine, Lung Diseases, Lay health worker, Veteran health
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants randomized to this arm of the study will receive usual clinical care.
Intervention Type
Behavioral
Intervention Name(s)
Receive education on precision medicine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Knowledge of precision medicine for cancer care from time of enrollment to 1 month post-enrollment
Description
Using 7 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.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Patient activation using the "Patient Activation Measure" survey
Description
Each patient will receive a validated patient activation survey using the "Patient Activation Measure" at baseline. This is a validated measure from Insignia Health. Responses are: disagree strongly, disagree, agree, agree strongly with higher activation correlated with responses of agree and agree strongly. Each item is rated on 4-point scale (1 strongly disagree to 4 strongly agree, with additional "not applicable" option). Higher scores indicate greater patient activation. For the PAM-10, minimum score is 0 (if all not-applicable) and maximum is 40. Raw scores are converted into activation levels per the scoring guidelines by Insignia Health for: level 1 Disengaged and Overwhelmed, level 2 Becoming Aware but Still Struggling, level 3 Taking Action and Gaining Control, level 4 Maintaining "Behaviors and Pushing Further. Scores for each group will be averaged at baseline.
Time Frame
Baseline
Title
Patient activation using the "Patient Activation Measure" survey
Description
Each patient will receive a validated patient activation survey using the "Patient Activation Measure" at 1 month post-enrollment. This is a validated measure from Insignia Health. Responses are: disagree strongly, disagree, agree, agree strongly with higher activation correlated with responses of agree and agree strongly. Each item is rated on 4-point scale (1 strongly disagree to 4 strongly agree, with additional "not applicable" option). Higher scores indicate greater patient activation. For the PAM-10, minimum score is 0 (if all not-applicable) and maximum is 40. Raw scores are converted into activation levels per the scoring guidelines by Insignia Health for: level 1 Disengaged and Overwhelmed, level 2 Becoming Aware but Still Struggling, level 3 Taking Action and Gaining Control, level 4 Maintaining "Behaviors and Pushing Further. Scores for each group will be averaged at 1 month post-enrollment
Time Frame
1 month post-enrollment
Title
Patient Satisfaction With Shared Decision Making using the "Shared Decision Making Questionnaire" Survey
Description
Using 7 items of the validated 9-item Shared Decision Making Questionnaire (SDM-Q-9) at baseline. Responses are "completely disagree, strongly disagree, somewhat disagree, somewhat agree, strongly agree, or completely agree," with 1=completely disagree and 6= completely agree. Higher scores indicate greater levels of satisfaction.
Time Frame
Baseline
Title
Patient Satisfaction With Shared Decision Making using the "Shared Decision Making Questionnaire" Survey
Description
Using 7 items of the validated 9-item Shared Decision Making Questionnaire (SDM-Q-9) at 1 month post-enrollment. Responses are "completely disagree, strongly disagree, somewhat disagree, somewhat agree, strongly agree, or completely agree," with 1=completely disagree and 6= completely agree. Higher scores indicate greater levels of satisfaction.
Time Frame
1 month post-enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients >18 years old that have been diagnosed with any stage of lung cancer within the past 8 months are eligible for this study.
Patients must have the ability to understand and willingness to provide verbal consent.
Participants must speak English.
Exclusion Criteria:
Inability to consent to the study, severe mental illness (e.g. schizophrenia) or institutionalization.
Patients who anticipate moving from the area within 6 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manali I Patel, MD MPH MS
Phone
6507234000
Email
Manalip@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manali I Patel, MD MPH MS
Organizational Affiliation
VA Palo Alto
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manali I Patel, MD MPH MS
Email
Manali.Patel2@va.gov
12. IPD Sharing Statement
Learn more about this trial
Ensuring Precision-Medicine Delivery for Veterans With Lung Cancer
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