Lung CancerNCT05795959
Ensuring Precision-Medicine Delivery for Veterans With Lung Cancer
A study testing Receive education on precision medicine in people with Lung Cancer, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Receive education on precision medicine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2023to 20 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Receive education on precision medicine
- Keywords
- Precision Medicine, Lung Diseases, Lay health worker, Veteran health
- Medical subject headings
- Lung Neoplasms, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Receive education on precision medicineBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Receive education on precision medicine |
| Control | No intervention | Participants randomized to this arm of the study will receive usual clinical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (6)
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 100. 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.
Measured: 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 100. 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
Measured: 1 month post-enrollment
Patient Satisfaction With Shared Decision Making using the "Shared Decision Making Questionnaire" Survey
Using 9 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.
Measured: Baseline
Patient Satisfaction With Shared Decision Making using the "Shared Decision Making Questionnaire" Survey
Using 9 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.
Measured: 1 month post-enrollment
Receipt of molecular testing
Chart review will be used to abstract whether participants received molecular testing
Measured: 6 months post-enrollment
Receipt of targeted therapy for those with an eligible molecular target
Chart review will be used to abstract whether participants with a molecular target received targeted treatment for the molecular target
Measured: 6 months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start20 Apr 2023
- Primary completion20 May 2024
- Study completion20 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manali Indravadan Patel, Stanford University
- Investigators
- Manali I Patel, MD MPH MS, Principal investigator, VA Palo Alto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795959
- Sponsor's protocol ID
- 67785
- Status last verified
- Feb 2025
- First submitted
- 9 Mar 2023
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Thomas M, Agrawal M, Das M, Patel MI. Effect of a Volunteer-Led Precision-Medicine Multilevel Intervention on Patient-Reported Outcomes, Receipt of Biomarker Testing, and Time to Treatment: A Randomized Clinical Trial. JCO Oncol Pract. 2026 Jul;22(7):1246-1253. doi: 10.1200/OP-25-00531. Epub 2025 Sep 15.
PubMed 40953357
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ensuring Precision-Medicine Delivery for Veterans With Lung Cancer
- ClinicalTrials.gov ID
- NCT05795959
- Acronym / sponsor ID
- 67785
- Conditions
- Lung Cancer
- Keywords
- Precision Medicine, Lung Diseases, Lay health worker, Veteran health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 20 May 2024 (actual)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Receive education on precision medicineParticipants 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. |
| Control | No intervention | –Participants randomized to this arm of the study will receive usual clinical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Receive education on precision medicinePatients 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. | Behavioural | Intervention |
Primary outcome
Knowledge of precision medicine for cancer care from time of enrollment to 1 month post-enrollment
Time frame: Baseline
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.
6 secondary outcomes
Patient activation using the "Patient Activation Measure" survey
Time frame: Baseline
Patient activation using the "Patient Activation Measure" survey
Time frame: 1 month post-enrollment
Patient Satisfaction With Shared Decision Making using the "Shared Decision Making Questionnaire" Survey
Time frame: Baseline
Patient Satisfaction With Shared Decision Making using the "Shared Decision Making Questionnaire" Survey
Time frame: 1 month post-enrollment
Receipt of molecular testing
Time frame: 6 months post-enrollment
Receipt of targeted therapy for those with an eligible molecular target
Time frame: 6 months post-enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Derived from this study: PubMed 40953357Thomas M, Agrawal M, Das M, Patel MI. Effect of a Volunteer-Led Precision-Medicine Multilevel Intervention on Patient-Reported Outcomes, Receipt of Biomarker Testing, and Time to Treatment: A Randomized Clinical Trial. JCO Oncol Pract. 2026 Jul;22(7):1246-1253. doi: 10.1200/OP-25-00531. Epub 2025 Sep 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manali I Patel, MD MPH MS principal investigator
VA Palo Alto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Receive education on precision medicine in people with Lung Cancer, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge of precision medicine for cancer care from time of enrollment to 1 month post-enrollment (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05795959, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.