End of LifeLEAPSNCT03699748
Lay Health Worker Engage, Educate, and Encourage Patients to Share
A study testing Lay Health Worker Intervention in people with End of Life and Cancer, run by Stanford University at 1 site in United States.
Trial summary
The purpose of the LEAPS program is to understand how a trained lay health worker who engages with newly diagnosed patients after a diagnosis of an advanced stage of cancer can help to engage patients in advance care planning, improve patient satisfaction with their decision-making, activation, quality of life, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End of Life, Cancer
- What is being tested?
- Lay Health Worker Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 30 Dec 2022
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed patients with a cancer diagnosis.
- Patients with any relapse or progressive disease (any cancer diagnosis) as identified by imaging or biopsy and confirmed by physician.
- The patients must be 18 years or older.
- Patients must have the capacity to verbally consent.
Who cannot join
- Inability to consent to the study due to lack of capacity as documented by the referring physician.
- Patients without a newly diagnosed malignancy or patients without relapse of disease.
- Patients not eligible for Fund benefits.
- Patients without a newly diagnosed malignancy or patients without relapse of disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
The purpose of the LEAPS program is to understand how a trained lay health worker who engages with newly diagnosed patients after a diagnosis of an advanced stage of cancer can help to engage patients in advance care planning, improve patient satisfaction with their decision-making, activation, quality of life, and healthcare resource utilization.
Read the detailed description
Unite Here Health proposes to implement and evaluate several critical elements to be in alignment with the mission of the organization to provide high value care to their members. The Lay Health Worker Engages, Educates, and Encourages Patients to Share intervention is an innovative program that will strengthen provider-patient relationship and facilitate whole person care about matters important to Unite Here Health members who are diagnosed with cancer and important to support network and family. The project is intended to help establish Goals of Care Plan with appropriate documentation, develop, deploy, and evaluate a model of care for persons with cancer that is intended to improve clinical outcomes and experience of care for individuals. The intervention provides patients with lay health coaches who assist patients and their families in discussing goals of care and engage in shared-decision making. The goal of the project is to demonstrate that there is improved documentation of goals of care, patient experiences, patient activation and quality of life outcomes, and that the program helps to reduce utilization of health care resources at the end of life.
- Conditions
- End of Life, Cancer
- Being tested
- Lay Health Worker Intervention, 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.
Lay Health Worker InterventionBehavioural
Patients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: education on early advance care planning, documenting goals of care, assessing symptoms, and coordinating community services (such as home health, home visits, and home hospice). The intervention is provided along with usual care as provided by Unite Here Health and local oncologists.
Usual CareOther
Usual care as provided by Unite Here Health and 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: education on early advance care planning, documenting goals of care, assessing symptoms, and coordinating community services (such as home health, home visits, and home hospice).
The intervention arm will also receive usual care as provided by Unite Here Health and their local oncologists. Receives: Behavioral: Lay Health Worker Intervention; Other: Usual Care |
| Control Group Arm | Active comparator | The control group arm will receive usual care as provided by Unite Here Health and their local oncologists. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Quality of Life Using the Functional Assessment of Cancer Therapy - General Survey
Each patient will receive a quality of life survey (Functional Assessment of Cancer Therapy - General Survey) at baseline and 4 months. We will measure the change in quality of life at baseline to 4 months. Scores for quality of life will be assessed using the Functional Assessment of Cancer Therapy - General (FACT-G), a 27-item questionnaire designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being. Each question is a 5-point likert scale item. Scores range from 0-108. The higher the score, the better the quality of life.
Measured: Change in Quality of Life from Baseline to 4 Months
Secondary outcomes (28)
Patient Satisfaction With Decision-Making Using the Satisfaction With Decision (SWD) Survey
The validated Satisfaction with Decision (SWD) Survey was administered to all participants at 4 months after study enrollment. The SWD is a 6-item questionnaire, where respondents rate their agreement with 6 statements (e.g. "I am satisfied that I am adequately informed about the issues important to my decision") on a likert-type scale. Answer options were (1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree. Responses to each item were averaged to give a score of 0 to 5 where 0 indicated lowest satisfaction and 5 indicated most satisfied with decision making. Scores for each group were averaged at 4 months after study enrollment. Results are expressed as a proportion of participants who responded "strongly agree" at 4 months post-enrollment on the SWD scale, which measured ratings of decision-making. Changes in the proportion of participants who responded "strongly agree" are reflected from baseline to 4 months post-enrollment.
Measured: Proportion of patients who strongly agree that decisions about their health care were theirs to make at 4 months post study enrollment.
Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey
The validated Satisfaction with Decision (SWD) Survey was administered to all participants at 12 months after study enrollment. The SWD is a 6-item questionnaire, where respondents rate their agreement with 6 statements (e.g. "I am satisfied that I am adequately informed about the issues important to my decision") on a likert-type scale. Answer options were (1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree. Responses to each item were averaged to give a score of 0 to 5 where 0 indicated lowest satisfaction and 5 indicated most satisfied with decision making. Scores for each group are averaged at 12 months after study enrollment. Results are expressed as a proportion of participants who responded "strongly agree" at 12 months post-enrollment on the SWD scale, which measured ratings of decision-making. Changes in the proportion of participants who responded "strongly agree" are reflected from baseline to 12 months.
Measured: Proportion of patients who strongly agree that decisions about their health care were theirs to make at 12 months post study enrollment.
Patient Activation Using the Patient Activation Measure Survey
Each patient will receive the 13-item Patient Activation Measure (PAM-13) at 4 months after study enrollment. This is a validated measure from Insignia Health. 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-13, minimum score is 0 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 4 months after study enrollment.
Measured: Change in Patient Activation Measure from baseline to 4 months post enrollment.
Patient Activation Using the Patient Activation Measure Survey
Each patient will receive the 13-item Patient Activation Measure (PAM-13) at 12 months after study enrollment. This is a validated measure from Insignia Health. 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-13, minimum score is 0 and maximum is 100 (highest level of activation). 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 12 months after study enrollment.
Measured: Change in Patient Activation Measure from baseline to 12 months post-enrollment.
Patient Quality of Life Using the Functional Assessment of Cancer Therapy - General Survey
Each patient will receive a quality of life survey (Functional Assessment of Cancer Therapy - General Survey) at 12 months. Scores for quality of life will be assessed using the Functional Assessment of Cancer Therapy - General Survey-General survey. The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being. Each question is a 5-point likert scale item. Scores range from 0-108. The higher the score, the better the quality of life.
Measured: Health-related quality of life at 12 months
Emergency Department Visit (Chart Review)
Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.
Measured: 4 months after patient enrollment
Emergency Department Visit (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.
Measured: 12 months after patient enrollment
Emergency Department Visit (Chart Review)
Emergency Department Use will be abstracted by electronic medical record chart review for each patient who is deceased within 12 months of enrollment, looking at their ER visits during the last 30 days of life.
Measured: Last 30 days of life up to 12 months from patient enrollment
Hospitalization Visit (Chart Review)
Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.
Measured: 4 months after patient enrollment
Hospitalization Visits (Chart Review)
Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.
Measured: 12 months after study enrollment
Hospitalization Visits (Chart Review)
Hospitalization use will be abstracted by electronic medical record chart review for each patient who is deceased within12 months of enrollment, looking at their hospital visits during the last 30 days of life.
Measured: last 30 days of life
Advance Directive Documentation (Chart Review)
Advance Directive documentation for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.
Measured: 4 months after patient enrollment
Advance Directive Documentation (Chart Review)
Advance Directive documentation 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
Physician Orders for Life Sustaining Treatment (Chart Review)
Physician Orders for Life Sustaining Treatment (POLST) documentation for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.
Measured: 4 months after patient enrollment
Physician Orders for Life Sustaining Treatment (Chart Review)
Physician Orders for Life Sustaining Treatment (POLST) documentation 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
Goals of Care Documentation (Chart Review)
Goals of Care documentation for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.
Measured: 4 months after patient enrollment
Goals of Care Documentation (Chart Review)
Goals of Care documentation 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 Costs of Care
Total Costs of Care will be evaluated by review of claims data from time of enrollment until 12 months post-enrollment
Measured: 12 months after patient enrollment
Total Costs of Care End of Life
Total Costs of Care during the last 30 days of life will be evaluated by review of claims data from the 30 days preceding death for those patients who become deceased within 12 months of study enrollment.
Measured: Last 30 days of life up to 12 months from patient enrollment
Palliative Care Use (Chart Review)
Palliative Care Use for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.
Measured: 4 months after patient enrollment
Palliative Care Use (Chart Review)
Palliative Care Use 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
Palliative Care Use (Chart Review)
Palliative Care Use will be abstracted by electronic medical record chart review for each patient who is deceased within12 months of enrollment, looking at their palliative care usage during the last 30 days of life.
Measured: last 30 days of life
Hospice Use (Chart Review)
Hospice Use for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.
Measured: 4 months after patient enrollment
Hospice Use (Chart Review)
Hospice Use 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
Hospice Use (Chart Review)
Hospice Use will be abstracted by electronic medical record chart review for each patient who is deceased within12 months of enrollment, looking at their hospice use during the last 30 days of life.
Measured: last 30 days of life
Survival (Chart Review)
Survival rate for patients will be abstracted by electronic medical record chart review at 4 months after enrollment.
Measured: 4 months after patient enrollment
Survival (Chart Review)
Survival rate for patients will be abstracted by electronic medical record chart review at 12 months after enrollment.
Measured: 12 months after patient enrollment
Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey
The validated Satisfaction with Decision (SWD) Survey was administered to all participants at baseline. The SWD is a 6-item questionnaire, where respondents rate their agreement with 6 statements (e.g. "I am satisfied that I am adequately informed about the issues important to my decision") on a likert-type scale. Answer options were (1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree. Responses to each item were averaged to give a score of 0 to 5 where 0 indicated lowest satisfaction and 5 indicated most satisfied with decision making. Results are expressed as a proportion of participants who responded "strongly agree" at Baseline on the Satisfaction with Decision scale, which measured ratings of decision-making.
Measured: Proportion of patients who strongly agreed the decisions about their health care were theirs to make at baseline (study enrollment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start1 Nov 2018
- Primary completion31 Dec 2021
- Study completion30 Dec 2022
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.
- Publications (2)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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- 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
- NCT03699748
- Sponsor's protocol ID
- 40447
- Other IDs
- K23MD013474-01
- Acronym
- LEAPS
- Status last verified
- Jul 2023
- First submitted
- 5 Oct 2018
- Last updated
- 7 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Patel MI, Kapphahn K, Wood E, Coker T, Salava D, Riley A, Krajcinovic I. Effect of a Community Health Worker-Led Intervention Among Low-Income and Minoritized Patients With Cancer: A Randomized Clinical Trial. J Clin Oncol. 2024 Feb 10;42(5):518-528. doi: 10.1200/JCO.23.00309. Epub 2023 Aug 25.
PubMed 37625110Patel MI, Khateeb S, Coker T. A randomized trial of a multi-level intervention to improve advance care planning and symptom management among low-income and minority employees diagnosed with cancer in outpatient community settings. Contemp Clin Trials. 2020 Apr;91:105971. doi: 10.1016/j.cct.2020.105971. Epub 2020 Mar 4.
PubMed 32145441
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lay Health Worker Engage, Educate, and Encourage Patients to Share
- ClinicalTrials.gov ID
- NCT03699748
- Acronym / sponsor ID
- LEAPS / 40447
- Conditions
- End of Life, Cancer
- Keywords
- cancer, end of life, patient-centered
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Posted 7 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the LEAPS program is to understand how a trained lay health worker who engages with newly diagnosed patients after a diagnosis of an advanced stage of cancer can help to engage patients in advance care planning, improve patient satisfaction with their decision-making, activation, quality of life, and healthcare resource utilization.
Detailed description
Unite Here Health proposes to implement and evaluate several critical elements to be in alignment with the mission of the organization to provide high value care to their members. The Lay Health Worker Engages, Educates, and Encourages Patients to Share intervention is an innovative program that will strengthen provider-patient relationship and facilitate whole person care about matters important to Unite Here Health members who are diagnosed with cancer and important to support network and family. The project is intended to help establish Goals of Care Plan with appropriate documentation, develop, deploy, and evaluate a model of care for persons with cancer that is intended to improve clinical outcomes and experience of care for individuals. The intervention provides patients with lay health coaches who assist patients and their families in discussing goals of care and engage in shared-decision making. The goal of the project is to demonstrate that there is improved documentation of goals of care, patient experiences, patient activation and quality of life outcomes, and that the program helps to reduce utilization of health care resources at the end of life.
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: Lay Health Worker Intervention, 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: education on early advance care planning, documenting goals of care, assessing symptoms, and coordinating community services (such as home health, home visits, and home hospice). The intervention arm will also receive usual care as provided by Unite Here Health and their local oncologists. |
| Control Group Arm | Active comparator | Other: Usual CareThe control group arm will receive usual care as provided by Unite Here Health and their local oncologists. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Newly diagnosed patients with a cancer diagnosis.
- Patients with any relapse or progressive disease (any cancer diagnosis) as identified by imaging or biopsy and confirmed by physician.
- The patients must be 18 years or older.
- Patients must have the capacity to verbally consent.
Key exclusion criteria (4 listed)
- Inability to consent to the study due to lack of capacity as documented by the referring physician.
- Patients without a newly diagnosed malignancy or patients without relapse of disease.
- Patients not eligible for Fund benefits.
- Patients without a newly diagnosed malignancy or patients without relapse of disease.
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 |
|---|---|---|
| Lay Health Worker InterventionPatients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: education on early advance care planning, documenting goals of care, assessing symptoms, and coordinating community services (such as home health, home visits, and home hospice). The intervention is provided along with usual care as provided by Unite Here Health and local oncologists. | Behavioural | Intervention Group Arm |
| Usual CareUsual care as provided by Unite Here Health and local oncologists | Other | Control Group Arm, Intervention Group Arm |
Primary outcome
Patient Quality of Life Using the Functional Assessment of Cancer Therapy - General Survey
Time frame: Change in Quality of Life from Baseline to 4 Months
Each patient will receive a quality of life survey (Functional Assessment of Cancer Therapy - General Survey) at baseline and 4 months. We will measure the change in quality of life at baseline to 4 months. Scores for quality of life will be assessed using the Functional Assessment of Cancer Therapy - General (FACT-G), a 27-item questionnaire designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being. Each question is a 5-point likert scale item. Scores range from 0-108. The higher the score, the better the quality of life.
28 secondary outcomes
Patient Satisfaction With Decision-Making Using the Satisfaction With Decision (SWD) Survey
Time frame: Proportion of patients who strongly agree that decisions about their health care were theirs to make at 4 months post study enrollment.
Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey
Time frame: Proportion of patients who strongly agree that decisions about their health care were theirs to make at 12 months post study enrollment.
Patient Activation Using the Patient Activation Measure Survey
Time frame: Change in Patient Activation Measure from baseline to 4 months post enrollment.
Patient Activation Using the Patient Activation Measure Survey
Time frame: Change in Patient Activation Measure from baseline to 12 months post-enrollment.
Patient Quality of Life Using the Functional Assessment of Cancer Therapy - General Survey
Time frame: Health-related quality of life at 12 months
Emergency Department Visit (Chart Review)
Time frame: 4 months after patient enrollment
Emergency Department Visit (Chart Review)
Time frame: 12 months after patient enrollment
Emergency Department Visit (Chart Review)
Time frame: Last 30 days of life up to 12 months from patient enrollment
Hospitalization Visit (Chart Review)
Time frame: 4 months after patient enrollment
Hospitalization Visits (Chart Review)
Time frame: 12 months after study enrollment
Hospitalization Visits (Chart Review)
Time frame: last 30 days of life
Advance Directive Documentation (Chart Review)
Time frame: 4 months after patient enrollment
Advance Directive Documentation (Chart Review)
Time frame: 12 months after patient enrollment
Physician Orders for Life Sustaining Treatment (Chart Review)
Time frame: 4 months after patient enrollment
Physician Orders for Life Sustaining Treatment (Chart Review)
Time frame: 12 months after patient enrollment
Goals of Care Documentation (Chart Review)
Time frame: 4 months after patient enrollment
Goals of Care Documentation (Chart Review)
Time frame: 12 months after patient enrollment
Total Costs of Care
Time frame: 12 months after patient enrollment
Total Costs of Care End of Life
Time frame: Last 30 days of life up to 12 months from patient enrollment
Palliative Care Use (Chart Review)
Time frame: 4 months after patient enrollment
Palliative Care Use (Chart Review)
Time frame: 12 months after patient enrollment
Palliative Care Use (Chart Review)
Time frame: last 30 days of life
Hospice Use (Chart Review)
Time frame: 4 months after patient enrollment
Hospice Use (Chart Review)
Time frame: 12 months after patient enrollment
Hospice Use (Chart Review)
Time frame: last 30 days of life
Survival (Chart Review)
Time frame: 4 months after patient enrollment
Survival (Chart Review)
Time frame: 12 months after patient enrollment
Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey
Time frame: Proportion of patients who strongly agreed the decisions about their health care were theirs to make at baseline (study enrollment).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37625110Patel MI, Kapphahn K, Wood E, Coker T, Salava D, Riley A, Krajcinovic I. Effect of a Community Health Worker-Led Intervention Among Low-Income and Minoritized Patients With Cancer: A Randomized Clinical Trial. J Clin Oncol. 2024 Feb 10;42(5):518-528. doi: 10.1200/JCO.23.00309. Epub 2023 Aug 25.
- Derived from this study: PubMed 32145441Patel MI, Khateeb S, Coker T. A randomized trial of a multi-level intervention to improve advance care planning and symptom management among low-income and minority employees diagnosed with cancer in outpatient community settings. Contemp Clin Trials. 2020 Apr;91:105971. doi: 10.1016/j.cct.2020.105971. Epub 2020 Mar 4.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lay Health Worker Intervention in people with End of Life and 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 4 inclusion and 4 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 7 Jul 2023. 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?
Yes. Results are posted in the registry (first posted 7 Jul 2023). 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?
Patient Quality of Life Using the Functional Assessment of Cancer Therapy - General Survey (time frame: Change in Quality of Life from Baseline to 4 Months). 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 NCT03699748, which also lists 2 linked publications.
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 7 Jul 2023.