CancerNCT03737058
Lay Health Worker Led Symptom Assessment Intervention
An observational study of Cancer, run by Stanford University.
Trial summary
Rising costs and poor patient experiences from under-treated symptoms have led to the demand for approaches that improve patients' experiences and lower expenditures. This observational project assigned a lay health worker to conduct proactive symptom assessments intended to achieve these goals among patients with… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer
- What is being tested?
- Program participants
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 288 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2015to 30 Dec 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who have a diagnosis of stage 3 and 4 cancers and who are receiving care at the Oncology Institute of Hope and Innovation and have CareMore Medicare Advantage as their healthcare payer plan.
Who may be able to join
- Clinical diagnosis of stage 3 and 4 cancer
- Clinical diagnosis of hematologic malignancy
- Must receive care at the Oncology Institute of Hope and Innovation
- Must be an enrollee of CareMore Medicare Advantage
Who cannot join
- None
About this study
Official title: Joint Oncology Collaboration for Proactive Symptom Assessments by a Lay Health Worker
Rising costs and poor patient experiences from under-treated symptoms have led to the demand for approaches that improve patients' experiences and lower expenditures. This observational project assigned a lay health worker to conduct proactive symptom assessments intended to achieve these goals among patients with advanced cancer.
Read the detailed description
All newly diagnosed Medicare Advantage enrollees with Stage 3 or 4 solid tumors or hematologic malignancies who planned to receive all oncology care at the Oncology Institute of Hope and Innovation from 11/1/2015 through 9/30/2016 were enrolled in the program. The program consisted of 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) with the frequency of symptom assessment varying based on patient risk. We evaluated feasibility, defined as monthly LHW documentation of symptom assessments, and change in patient-reported satisfaction and overall and emotional and mental health with validated assessments at enrollment and 5-months post-enrollment among patients in the intervention. We compared healthcare use and costs to a historical cohort of similar Medicare Advantage enrollees diagnosed between 11/1/2014-10/31/2015 (control). We assessed differences in demographic and clinical factors between the two groups using chi-square and t-tests and used generalized linear models to evaluate differences in healthcare use and costs.
- Conditions
- Cancer
- Being tested
- Program participants
- Medical subject headings
- 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 Assessment Scale (ESAS) (cite) with the frequency of symptom assessment varying based on patient risk.
What is being measured
The primary outcome is the main question the study is designed to answer.
Edmonton Symptom Assessment Scale Score (ESAS)
ESAS measures participant responses to 10 common symptoms (pain, fatigue, nausea, depression, anxiety, drowsiness, shortness of breath, appetite, sleep problems, and feeling of well-being). Participants rate the intensity of 10 symptoms, each on a 11-point scale (0 to 10); sub-scores are then summed and averaged to create a total symptom score (range: 0 to 10, with 10 corresponding to worst symptom severity).
Measured: 12 months after patient enrollment
Secondary outcomes (5)
Incidence of Emergency Department Visits
Emergency Department use for each patient abstracted from medical claims data review for each patient at 12 months after enrollment.
Measured: 12 months after patient enrollment
Hospitalization Visits (Claims Review)
Hospitalization Use 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
Intensive Care Unit Visits (Claims Review)
Intensive Care Unit Visits 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
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
Change in Patient Satisfaction With Care Using the Consumer Assessment of Health Care Providers and Systems -General Survey
Each patient will receive a satisfaction with care survey (The Consumer Assessment of Health Care Providers and Systems - General (CAHPS)) at baseline and 5 months. We will measure the change in satisfaction from calculated as the value at 5 months minus the baseline value. Scores for satisfaction were assessed using the Consumer Assessment of Healthcare Providers and Systems-General survey question #18 which measured rating of health provider, on which scores range from 0 to 10, with higher ratings correspond to higher patient satisfaction. Scores for each group are averaged at baseline and at 12 months.
Measured: Change in Patient Satisfaction with Care from baseline to 5 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start1 Nov 2015
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manali Indravadan Patel, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03737058
- Sponsor's protocol ID
- SU12
- Status last verified
- Feb 2025
- First submitted
- 7 Nov 2018
- Last updated
- 27 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Joint Oncology Collaboration for Proactive Symptom Assessments by a Lay Health Worker
- ClinicalTrials.gov ID
- NCT03737058
- Acronym / sponsor ID
- SU12
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 9 Nov 2018 (actual)
- Results
- Posted 27 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rising costs and poor patient experiences from under-treated symptoms have led to the demand for approaches that improve patients' experiences and lower expenditures. This observational project assigned a lay health worker to conduct proactive symptom assessments intended to achieve these goals among patients with advanced cancer.
Detailed description
All newly diagnosed Medicare Advantage enrollees with Stage 3 or 4 solid tumors or hematologic malignancies who planned to receive all oncology care at the Oncology Institute of Hope and Innovation from 11/1/2015 through 9/30/2016 were enrolled in the program. The program consisted of 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) with the frequency of symptom assessment varying based on patient risk. We evaluated feasibility, defined as monthly LHW documentation of symptom assessments, and change in patient-reported satisfaction and overall and emotional and mental health with validated assessments at enrollment and 5-months post-enrollment among patients in the intervention. We compared healthcare use and costs to a historical cohort of similar Medicare Advantage enrollees diagnosed between 11/1/2014-10/31/2015 (control). We assessed differences in demographic and clinical factors between the two groups using chi-square and t-tests and used generalized linear models to evaluate differences in healthcare use and costs.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who have a diagnosis of stage 3 and 4 cancers and who are receiving care at the Oncology Institute of Hope and Innovation and have CareMore Medicare Advantage as their healthcare payer plan.
Key inclusion criteria (4 listed)
- Clinical diagnosis of stage 3 and 4 cancer
- Clinical diagnosis of hematologic malignancy
- Must receive care at the Oncology Institute of Hope and Innovation
- Must be an enrollee of CareMore Medicare Advantage
Key exclusion criteria (1 listed)
- None
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 Assessment Scale (ESAS) (cite) with the frequency of symptom assessment varying based on patient risk. | Behavioural | – |
Primary outcome
Edmonton Symptom Assessment Scale Score (ESAS)
Time frame: 12 months after patient enrollment
ESAS measures participant responses to 10 common symptoms (pain, fatigue, nausea, depression, anxiety, drowsiness, shortness of breath, appetite, sleep problems, and feeling of well-being). Participants rate the intensity of 10 symptoms, each on a 11-point scale (0 to 10); sub-scores are then summed and averaged to create a total symptom score (range: 0 to 10, with 10 corresponding to worst symptom severity).
5 secondary outcomes
Incidence of Emergency Department Visits
Time frame: 12 months after patient enrollment
Hospitalization Visits (Claims Review)
Time frame: 12 months after patient enrollment
Intensive Care Unit Visits (Claims Review)
Time frame: 12 months after patient enrollment
Total Health Care Costs (Claims Review)
Time frame: 12 months after patient enrollment
Change in Patient Satisfaction With Care Using the Consumer Assessment of Health Care Providers and Systems -General Survey
Time frame: Change in Patient Satisfaction with Care from baseline to 5 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Stanford University.
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 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 27 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Edmonton Symptom Assessment Scale Score (ESAS) (time frame: 12 months after patient enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2025.