End of LifeNCT04463992
Lay Health Worker Expanded Intervention in Community Oncology Practices
A study testing Program participants in people with End of Life and Cancer, run by Stanford University at 2 sites in United States.
Trial summary
Undertreated patient symptoms and resulting acute care use require approaches that improve symptom-burden. Previously a lay health worker (LHW)-led symptom screening intervention was developed for patients with cancer. Read more about this study
- Who is it for?
- Ages 75 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- End of Life, Cancer
- What is being tested?
- Program participants
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Oct 2020to 17 Oct 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 75 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Newly diagnosed or relapsed cancer diagnosis.
- 75 years or older
- Diagnosis of relapse or progressive disease (any cancer diagnosis) as identified by imaging or biopsy and confirmed by physician.
- Must have capacity to verbally consent
Who cannot join
- Inability to consent to the study due to lack of capacity as documented by the referring physician.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Oncology Institute of Hope and Innovation
Henderson, Nevada, 89052
The Oncology Institute of Hope and Innovation
Tucson, Arizona, 85710
About this study
Undertreated patient symptoms and resulting acute care use require approaches that improve symptom-burden. Previously a lay health worker (LHW)-led symptom screening intervention was developed for patients with cancer. In pilot work, the intervention was associated with improvements in patient symptom burden and reductions in healthcare use and costs of care at the end of life. This intervention will be expanded across several clinics to evaluate the impact of the LHW intervention on with cancer and the LHW will be trained to refer patients to palliative care. This randomized intervention will evaluate the effect on healthcare use, total costs, palliative care and hospice referral.
Read the detailed description
All patients with newly diagnosed cancer, over the age of 75 will be randomized into the CareMore Pilot 2 Program with 200 randomized to the intervention grou and 200 randomized to the control group.
- Conditions
- End of Life, Cancer
- Being tested
- Program participants, Usual Care
- Keywords
- cancer end of life patient-centered
- Medical subject headings
- Death, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Program participantsBehavioural
The intervention is a 12-month telephonic program in which a lay health worker (LHW), supervised on-site by a registered nurse practitioner (RNP), assessed patient symptoms after diagnosis using the validated Edmonton Symptom The intervention is a 12-month telephonic program in which a lay health worker (LHW), supervised on-site by a registered nurse practitioner (RNP), assessed patient symptoms after diagnosis using the validated Edmonton Symptom Assessment Scale (ESAS) (cite) with the frequency of symptom assessment varying based on patient risk.
Usual CareOther
Usual care as provided by local oncologists
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group Arm | Experimental | Patients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: proactive symptom assessments for patients for up to 12-months. Receives: Behavioral: Program participants; Other: Usual Care |
| Behavioral:Program participants | Active comparator | The control group arm will receive usual care as provided by their local oncologists. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of patients with Emergency Department Visit within 12-months after patient enrollment (Chart Review)
Emergency Department use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of the % of patients with emergency department visits between study arms.
Measured: 12 months after patient enrollment
% of patients with Hospitalization Visits within 12 months after patient enrollment (Chart Review)
Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of hospitalizations between the two study arms.
Measured: 12 months after patient enrollment
Secondary outcomes (7)
% of patients with a Hospice Consult within 12-months after patient enrollment (Chart Review)
Hospice consult for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.
Measured: 12 months after patient enrollment
Total Health Care Costs (Claims Review)
Total Health Care Costs for each patient will be abstracted by medical claims data review for each patient at 12 months after enrollment.
Measured: 12 months after patient enrollment
% of patients with an Acute Care Facility Death (Chart Review)
Acute Care Facility Deaths for each patient will be abstracted by electronic medical record chart review and claims review for each patient who has died at 12-months followup. We will evaluate comparisons of Acute Care Facility Deaths between study arms.
Measured: 30 days prior to death for patients who died at 12-months follow-up
% of patients with Emergency Department Visit in the last 30 days of life (Chart Review)
Emergency Department use for each patient will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of emergency department visits between study arms.
Measured: 30 days prior to death for patients who died at 12-months follow-up
% of patients with Hospitalization Visits in the last 30 days of life (Chart Review)
Hospital use for each patient will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of hospitalization use between study arms.
Measured: 30 days prior to death for patients who died at 12-months follow-up
% of patients with a Hospice Consult in the last 30 days of life (Chart Review)
Hospice use for each patient will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of hospice use between study arms.
Measured: 30 days prior to death for patients who died at 12-months follow-up
Total Costs of Care (Claims Review)
Total costs of care for each patient will be obtained through claims data for each patient for each patient who has died. We will evaluate comparisons of Total costs of care between study arms.
Measured: Time of enrollment to 12 months followup or death, whichever is first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start5 Oct 2020
- Primary completion17 Oct 2024
- Study completion17 Oct 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 End of LifeStudies 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
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 416 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, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463992
- Sponsor's protocol ID
- 57643
- Status last verified
- Apr 2025
- First submitted
- 4 Jul 2020
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Patel MI, Voskanyan M, Agajanian H, Agajanian R, Podnos Y, Milstein A. A Lay Health Worker-Led Symptom Intervention and Acute Care Use in Older Adults With Cancer: A Randomized Clinical Trial. JAMA. 2026 Feb 24;335(8):674-681. doi: 10.1001/jama.2025.23403.
PubMed 41468027
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lay Health Worker Expanded Intervention in Community Oncology Practices
- ClinicalTrials.gov ID
- NCT04463992
- Acronym / sponsor ID
- 57643
- Conditions
- End of Life, Cancer
- Keywords
- cancer end of life patient-centered
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 17 Oct 2024 (actual)
- Study completion
- 17 Oct 2024 (actual)
- First posted
- 9 Jul 2020 (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.
Undertreated patient symptoms and resulting acute care use require approaches that improve symptom-burden. Previously a lay health worker (LHW)-led symptom screening intervention was developed for patients with cancer. In pilot work, the intervention was associated with improvements in patient symptom burden and reductions in healthcare use and costs of care at the end of life. This intervention will be expanded across several clinics to evaluate the impact of the LHW intervention on with cancer and the LHW will be trained to refer patients to palliative care. This randomized intervention will evaluate the effect on healthcare use, total costs, palliative care and hospice referral.
Detailed description
All patients with newly diagnosed cancer, over the age of 75 will be randomized into the CareMore Pilot 2 Program with 200 randomized to the intervention grou and 200 randomized to the control group.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group Arm | Experimental | Behavioral: Program participants, Other: Usual CarePatients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: proactive symptom assessments for patients for up to 12-months. |
| Behavioral:Program participants | Active comparator | Other: Usual CareThe control group arm will receive usual care as provided by their local oncologists. |
Who may qualify
- Ages
- 75 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Newly diagnosed or relapsed cancer diagnosis.
- 75 years or older
- Diagnosis of relapse or progressive disease (any cancer diagnosis) as identified by imaging or biopsy and confirmed by physician.
- Must have capacity to verbally consent
Key exclusion criteria (1 listed)
- Inability to consent to the study due to lack of capacity as documented by the referring physician.
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 |
|---|---|---|
| Program participantsThe intervention is a 12-month telephonic program in which a lay health worker (LHW), supervised on-site by a registered nurse practitioner (RNP), assessed patient symptoms after diagnosis using the validated Edmonton Symptom The intervention is a 12-month telephonic program in which a lay health worker (LHW), supervised on-site by a registered nurse practitioner (RNP), assessed patient symptoms after diagnosis using the validated Edmonton Symptom Assessment Scale (ESAS) (cite) with the frequency of symptom assessment varying based on patient risk. | Behavioural | Intervention Group Arm |
| Usual CareUsual care as provided by local oncologists | Other | Behavioral:Program participants, Intervention Group Arm |
Primary outcome
% of patients with Emergency Department Visit within 12-months after patient enrollment (Chart Review)
Time frame: 12 months after patient enrollment
Emergency Department use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of the % of patients with emergency department visits between study arms.
% of patients with Hospitalization Visits within 12 months after patient enrollment (Chart Review)
Time frame: 12 months after patient enrollment
Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of hospitalizations between the two study arms.
7 secondary outcomes
% of patients with a Hospice Consult within 12-months after patient enrollment (Chart Review)
Time frame: 12 months after patient enrollment
Total Health Care Costs (Claims Review)
Time frame: 12 months after patient enrollment
% of patients with an Acute Care Facility Death (Chart Review)
Time frame: 30 days prior to death for patients who died at 12-months follow-up
% of patients with Emergency Department Visit in the last 30 days of life (Chart Review)
Time frame: 30 days prior to death for patients who died at 12-months follow-up
% of patients with Hospitalization Visits in the last 30 days of life (Chart Review)
Time frame: 30 days prior to death for patients who died at 12-months follow-up
% of patients with a Hospice Consult in the last 30 days of life (Chart Review)
Time frame: 30 days prior to death for patients who died at 12-months follow-up
Total Costs of Care (Claims Review)
Time frame: Time of enrollment to 12 months followup or death, whichever is first
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 27 Apr 2025.
- Derived from this study: PubMed 41468027Patel MI, Voskanyan M, Agajanian H, Agajanian R, Podnos Y, Milstein A. A Lay Health Worker-Led Symptom Intervention and Acute Care Use in Older Adults With Cancer: A Randomized Clinical Trial. JAMA. 2026 Feb 24;335(8):674-681. doi: 10.1001/jama.2025.23403.
- Individual participant dataSharing planned: No
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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
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Program participants in people with End of Life and Cancer, run by Stanford University at 2 sites 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 4 inclusion and 1 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 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
% of patients with Emergency Department Visit within 12-months after patient enrollment (Chart Review) (time frame: 12 months after patient enrollment). The study lists 2 primary outcomes in all. 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 NCT04463992, 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 27 Apr 2025.