Acute Myeloid LeukemiaNCT03154190
Health Care Coach Support in Reducing Acute Care Use and Cost in Patients With Cancer
A study testing Best Practice, Laboratory Biomarker Analysis and Supportive Care in people with Acute Myeloid Leukemia and Brain Glioblastoma, run by Stanford University at 1 site in United States.
Trial summary
This randomized pilot clinical trial studies health care coach support in reducing acute care use and cost in patients with cancer. Health care coach support may help cancer patients to make decisions about their care that matches what is important to them with symptom management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Brain Glioblastoma, Estrogen Receptor Negative
- What is being tested?
- Best Practice, Laboratory Biomarker Analysis and Supportive Care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2017to 30 Aug 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 for the following conditions
- Colon cancer stage III and IV
- Rectal cancer stage II, III, IV
- Glioblastoma multiforme (brain) -- no stage
- Non-small cell lung cancer stage IIIA, IIIB, IV
- Small cell lung cancer, limited stage and extensive stage
Show all 22Show fewer
- Castration-resistant prostate cancer
- Head and neck cancer stage III and IV
- Gastric cancer stage III and IV
- Esophageal cancer stage III and IV
- Pancreatic cancer stage II, III, IV
- Renal cell carcinoma, stage IV
- Breast cancer, stage IV, if triple negative ER/PR/H2N negative or on systemic chemotherapy
- Sarcoma, stage IV
- Bladder carcinoma, stage IV
- Acute myeloid leukemia
- Melanoma, stage III and IV
- Ovarian cancer, stage III and IV
- High grade myelodysplastic syndrome (MDS)
- Any patient with recurrent or progressive cancer
- Patients must have the ability to understand and willingness to sign a written informed consent document
- Patient must have ongoing oncologic needs and plan to receive all care at the study institution and not already be in hospice or home-care
Who cannot join
- Patients must have capacity to consent
- Pregnant patients are excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia K Crosson Cancer Center
Fullerton, California, 29835
About this study
Official title: St. Judes-Stanford Comprehensive Support Initiative
This randomized pilot clinical trial studies health care coach support in reducing acute care use and cost in patients with cancer. Health care coach support may help cancer patients to make decisions about their care that matches what is important to them with symptom management.
Read the detailed description
PRIMARY OBJECTIVES:
- To reduce acute care utilization by 2-5% for advanced cancer patients by training and deploying health care coaches who help patients and families discuss care goals, virtual modalities, engage in shared-decision-making, and participate in educational activities.
SECONDARY OBJECTIVES:
- To improve patients' experience of their care. II. Improve patient understanding of advanced care planning. III. To improve the receipt of goal concordant care. IV. To reduce total healthcare costs.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive usual care.
ARM B: Patients undergo health care coach support with a baseline introduction (either telephonic or in-person) of the program followed by a visit (telephonic or in-person) with the health care coach after the first oncology appointment to discuss goals of care. The health care coach will contact patient based on patients' ongoing needs (weekly to monthly) and will conduct symptom assessments based on patients' treatment plans and symptoms.
After completion of study, patients are followed up for 6 months.
- Conditions
- Acute Myeloid Leukemia, Brain Glioblastoma, Estrogen Receptor Negative, Extensive Stage Small Cell Lung Carcinoma, Head and Neck Carcinoma, HER2/Neu Negative
- Being tested
- Best Practice, Laboratory Biomarker Analysis, Supportive Care, Survey Administration
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Disease Progression, Recurrence, Pancreatic Neoplasms, Rectal Neoplasms, Colonic Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive usual care
Laboratory Biomarker AnalysisOther
Correlative studies
Supportive CareProcedure or surgery
Also called Supportive Therapy, Symptom Management, Therapy, Supportive
Undergo health care coach support
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm A (usual care) | Active comparator | Patients receive usual care. Receives: Other: Best Practice; Other: Laboratory Biomarker Analysis; Other: Survey Administration |
| Arm B (health care coach support) | Experimental | Patients undergo health care coach support with a baseline introduction (either telephonic or in-person) of the program followed by a visit (telephonic or in-person) with the health care coach after the first oncology appointment to discuss goals of care. The health care coach will contact patient based on patients' ongoing needs (weekly to monthly) and will conduct symptom assessments based on patients' treatment plans and symptoms. Receives: Other: Laboratory Biomarker Analysis; Procedure: Supportive Care; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Emergency Department Visits (Chart Review)
Mean emergency department visits for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment. We will evaluate comparisons of mean numbers of emergency department visits between study arms.
Measured: 6 months after patient enrollment
Number of Hospitalization Visits (Chart Review)
Mean Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment. We will evaluate comparisons of mean numbers of hospitalizations between the two study arms.
Measured: 6 months after patient enrollment
Secondary outcomes (12)
Change in Patient Satisfaction With Care and Decision Making Among Patients Undergoing Health Care Coach Support as Assessed by Consumer Assessment of Healthcare Providers and Systems-G and Patient Satisfaction With Decision Scale
Each patient will receive a satisfaction with decision-making survey (The Satisfaction with Decision Survey) at baseline, 6 months, and 12 months.
Satisfaction with Decision was assessed using the Satisfaction with Decision scale, which measured rating of decision-making. Questions were assessed with responses on a scale of "strongly disagree," "disagree," "neither agree nor disagree," "agree," or "strongly agree." Results are expressed as proportion of participants who responded "strongly agree."
Measured: Change in patient satisfaction with care and decision making from baseline to 6 and 12 months
Change in Patient Satisfaction With Care Among Patients Undergoing Health Care Coach Support as Assessed by Consumer Assessment of Healthcare Providers and Systems-G.
Each patient will receive a satisfaction with care survey (The Consumer Assessment of Healthcare Providers and Systems-G) at baseline, 6 months, and 12 months.
Overall Health and Overall Mental or Emotional health was assessed using the Consumer Assessment of Health Care Providers and Systems-Clinician and Group Survey version 2.0 (cite) questions #26, which measured rating of overall health with responses, "excellent," "very good," "fair," or "poor." Questions were assessed with responses "never", "sometimes," "usually," or "always," or care rated as "worst," "fair," good", or "best." Results are expressed as proportion of participants who responded "always", or "best care."
Measured: Change in patient satisfaction with care from baseline to 6 and 12 months
Mean Emergency Department Visits (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 emergency department visits between study arms.
Measured: 12 months after patient enrollment
Number of People With Emergency Department Visit (Chart Review)
Number of people with Emergency Department use in the 30 days before death will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of the number of people with emergency department visits between study arms.
Measured: 30 days prior to death
Hospitalization Visits (Chart Review)
Hospital 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 hospitalization use between study arms.
Measured: 12 months after patient enrollment
Number of Patients With Hospital Use (Chart Review)
Number of patients with hospital use in the 30 days before death will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of proportion of people with hospitalization use between study arms in the 30 days before death.
Measured: 30 days prior to death
Hospice Consult (Chart Review)
Hospice 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 hospice use between study arms.
Measured: 6 months after patient enrollment
Hospice Consult (Chart Review)
Hospice 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 hospice use between study arms.
Measured: 12 months after patient enrollment
Hospice Consult (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
Palliative Care Consult (Chart Review)
Palliative Care consult 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 palliative care use between study arms.
Measured: 6 months after patient enrollment
Palliative Care Consult (Chart Review)
Palliative Care consult 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 palliative care use between study arms.
Measured: 12 months after patient enrollment
Palliative Care Consult (Chart Review)
Palliative Care consult for each patient will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of palliative care use between study arms.
Measured: 30 days prior to death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start8 Aug 2017
- Primary completion30 Nov 2021
- Study completion30 Aug 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 Acute Myeloid LeukemiaStudies 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
- None (open label)
- Enrolment
- 128 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 Patel, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154190
- Sponsor's protocol ID
- VAR0134
- Status last verified
- Dec 2024
- First submitted
- 14 Nov 2016
- Last updated
- 24 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Patel MI, Kapphahn K, Dewland M, Aguilar V, Sanchez B, Sisay E, Murillo A, Smith K, Park DJ. Effect of a Community Health Worker Intervention on Acute Care Use, Advance Care Planning, and Patient-Reported Outcomes Among Adults With Advanced Stages of Cancer: A Randomized Clinical Trial. JAMA Oncol. 2022 Aug 1;8(8):1139-1148. doi: 10.1001/jamaoncol.2022.1997.
PubMed 35771552Patel MI, Aguilar V, Sanchez B, Sisay E, Park DJ. Health care coach support to assist with advance care planning and symptom management -A randomized controlled trial. Contemp Clin Trials. 2021 Dec;111:106617. doi: 10.1016/j.cct.2021.106617. Epub 2021 Nov 5.
PubMed 34749008
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- St. Judes-Stanford Comprehensive Support Initiative
- ClinicalTrials.gov ID
- NCT03154190
- Acronym / sponsor ID
- VAR0134
- Conditions
- Acute Myeloid Leukemia, Brain Glioblastoma, Estrogen Receptor Negative, Extensive Stage Small Cell Lung Carcinoma, Head and Neck Carcinoma, HER2/Neu Negative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 8 Aug 2017 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 16 May 2017 (actual)
- Results
- Posted 24 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized pilot clinical trial studies health care coach support in reducing acute care use and cost in patients with cancer. Health care coach support may help cancer patients to make decisions about their care that matches what is important to them with symptom management.
Detailed description
PRIMARY OBJECTIVES:
- To reduce acute care utilization by 2-5% for advanced cancer patients by training and deploying health care coaches who help patients and families discuss care goals, virtual modalities, engage in shared-decision-making, and participate in educational activities.
SECONDARY OBJECTIVES:
- To improve patients' experience of their care. II. Improve patient understanding of advanced care planning. III. To improve the receipt of goal concordant care. IV. To reduce total healthcare costs.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive usual care.
ARM B: Patients undergo health care coach support with a baseline introduction (either telephonic or in-person) of the program followed by a visit (telephonic or in-person) with the health care coach after the first oncology appointment to discuss goals of care. The health care coach will contact patient based on patients' ongoing needs (weekly to monthly) and will conduct symptom assessments based on patients' treatment plans and symptoms.
After completion of study, patients are followed up for 6 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (usual care) | Active comparator | Other: Best Practice, Other: Laboratory Biomarker Analysis, Other: Survey AdministrationPatients receive usual care. |
| Arm B (health care coach support) | Experimental | Other: Laboratory Biomarker Analysis, Procedure: Supportive Care, Other: Survey AdministrationPatients undergo health care coach support with a baseline introduction (either telephonic or in-person) of the program followed by a visit (telephonic or in-person) with the health care coach after the first oncology appointment to discuss goals of care. The health care coach will contact patient based on patients' ongoing needs (weekly to monthly) and will conduct symptom assessments based on patients' treatment plans and symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Newly diagnosed patients for the following conditions
- Any patient with recurrent or progressive cancer
- Patients must have the ability to understand and willingness to sign a written informed consent document
- Patient must have ongoing oncologic needs and plan to receive all care at the study institution and not already be in hospice or home-care
Key exclusion criteria (2 listed)
- Patients must have capacity to consent
- Pregnant patients are excluded
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 |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive usual care | Other | Arm A (usual care) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm A (usual care), Arm B (health care coach support) |
| Supportive CareAlso: Supportive Therapy, Symptom Management, Therapy, SupportiveUndergo health care coach support | Procedure or surgery | Arm B (health care coach support) |
| Survey AdministrationAncillary studies | Other | Arm A (usual care), Arm B (health care coach support) |
Primary outcome
Number of Emergency Department Visits (Chart Review)
Time frame: 6 months after patient enrollment
Mean emergency department visits for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment. We will evaluate comparisons of mean numbers of emergency department visits between study arms.
Number of Hospitalization Visits (Chart Review)
Time frame: 6 months after patient enrollment
Mean Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment. We will evaluate comparisons of mean numbers of hospitalizations between the two study arms.
12 secondary outcomes
Change in Patient Satisfaction With Care and Decision Making Among Patients Undergoing Health Care Coach Support as Assessed by Consumer Assessment of Healthcare Providers and Systems-G and Patient Satisfaction With Decision Scale
Time frame: Change in patient satisfaction with care and decision making from baseline to 6 and 12 months
Change in Patient Satisfaction With Care Among Patients Undergoing Health Care Coach Support as Assessed by Consumer Assessment of Healthcare Providers and Systems-G.
Time frame: Change in patient satisfaction with care from baseline to 6 and 12 months
Mean Emergency Department Visits (Chart Review)
Time frame: 12 months after patient enrollment
Number of People With Emergency Department Visit (Chart Review)
Time frame: 30 days prior to death
Hospitalization Visits (Chart Review)
Time frame: 12 months after patient enrollment
Number of Patients With Hospital Use (Chart Review)
Time frame: 30 days prior to death
Hospice Consult (Chart Review)
Time frame: 6 months after patient enrollment
Hospice Consult (Chart Review)
Time frame: 12 months after patient enrollment
Hospice Consult (Chart Review)
Time frame: 30 days prior to death
Palliative Care Consult (Chart Review)
Time frame: 6 months after patient enrollment
Palliative Care Consult (Chart Review)
Time frame: 12 months after patient enrollment
Palliative Care Consult (Chart Review)
Time frame: 30 days prior to death
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35771552Patel MI, Kapphahn K, Dewland M, Aguilar V, Sanchez B, Sisay E, Murillo A, Smith K, Park DJ. Effect of a Community Health Worker Intervention on Acute Care Use, Advance Care Planning, and Patient-Reported Outcomes Among Adults With Advanced Stages of Cancer: A Randomized Clinical Trial. JAMA Oncol. 2022 Aug 1;8(8):1139-1148. doi: 10.1001/jamaoncol.2022.1997.
- Derived from this study: PubMed 34749008Patel MI, Aguilar V, Sanchez B, Sisay E, Park DJ. Health care coach support to assist with advance care planning and symptom management -A randomized controlled trial. Contemp Clin Trials. 2021 Dec;111:106617. doi: 10.1016/j.cct.2021.106617. Epub 2021 Nov 5.
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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 Patel 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 Best Practice, Laboratory Biomarker Analysis and Supportive Care in people with Acute Myeloid Leukemia and Brain Glioblastoma, 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 22 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 24 Jan 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?
Yes. Results are posted in the registry (first posted 24 Jan 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?
Number of Emergency Department Visits (Chart Review) (time frame: 6 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 NCT03154190, 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 24 Jan 2025.