CancerCAREPlanNCT03856463
Coaches Activating Reaching and Engaging Patients
A study testing Lay Navigator Intervention in people with Cancer and End-of-Life, run by Stanford University at 1 site in United States.
Trial summary
The purpose of the Team Based Advance Care Planning CAREPLAN program is to understand if a trained lay navigator who engages with patients with advanced stages of cancer can help patients in advance care planning, improve patient activation, satisfaction, quality of life, and the quality of end of life cancer care… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, End-of-Life
- What is being tested?
- Lay Navigator Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2019to 25 Sep 2023
- 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 who receive care at Stanford Cancer Institute and have genitourinary cancers and have received greater than 2 prior courses of chemotherapy treatment
Who cannot join
- Patients without capacity to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: CAREPlan: Coaches Activating, Reaching, and Engaging Patients in End-of-Life Care Plan
The purpose of the Team Based Advance Care Planning CAREPLAN program is to understand if a trained lay navigator who engages with patients with advanced stages of cancer can help patients in advance care planning, improve patient activation, satisfaction, quality of life, and the quality of end of life cancer care while also ensuring goal concordant cancer care at the end of life.
Read the detailed description
Stanford Cancer Institute plans to implement and evaluate several critical elements to be in alignment with the mission of the organization to provide high value care to their patients. The CAREPLAN (Coaches Activating, Reaching, and Engaging Patients in Their End of Life Care Plan) intervention is an innovative program aimed to strengthen provider-patient relationships and facilitate whole person care about matters important to patients diagnosed with advanced stages of cancer and important to patients' support network and family. The project is intended to help establish patients' Goals of Care Plan with appropriate documentation, develop, deploy, and evaluate a model of care for patients with cancer that is intended to improve clinical outcomes and their experiences with their cancer care. The intervention provides patients with lay navigators who assist them and their families in formulating and discussing their goals of care with their health care teams in hopes to engage in shared-decision making for goal concordant care. The goal of the project is to demonstrate that there is improved documentation of goals of care, patient experiences, patient activation, quality of life, and quality of care and communication and that the program helps to improve goal concordant care receipt at the end of life.
- Conditions
- Cancer, End-of-Life
- Being tested
- Lay Navigator Intervention, Usual Care
- Keywords
- end of life, quality of care, cancer care delivery
- Medical subject headings
- Neoplasms, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lay Navigator InterventionBehavioural
Also called Intervention Group Arm
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 and documenting goals of care.
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 patient navigator who will provide information regarding early advance care planning, documentation of goals of care, and coordinating home-based care. The intervention arm will also receive usual care as provided by their local oncologists. Receives: Behavioral: Lay Navigator Intervention; Other: Usual Care |
| Control Group Arm | Active comparator | The control group 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.
Goals of Care Documentation
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
Secondary outcomes (4)
Emergency Department Visit using chart abstraction
Emergency Department Use for each patient will be assessed by electronic health record abstraction from time of enrollment to 12 months after patient enrollment
Measured: 12 months after patient enrollment
Hospitalization Visit using chart abstraction
Hospitalization Visits for each patient will be assessed by electronic health record abstraction from time of enrollment to 12 months after patient enrollment
Measured: 12 months after patient enrollment
Palliative care using chart abstraction
Palliative care use for each patient will be assessed by electronic health record abstraction from time of enrollment to 12 months after patient enrollment
Measured: 12 months after patient enrollment
Hospice using chart abstraction
Hospice for each patient will be assessed by electronic health record abstraction from time of enrollment to 12 months after patient enrollment
Measured: 12 months after patient enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start3 Apr 2019
- Primary completion3 Apr 2023
- Study completion25 Sep 2023
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 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
- As part of usual care, patients with cancer are assigned to services by a lay navigator and this will be the control group. For patients in the intervention, they will be assigned to the usual care lay navigator but will receive services by a lay navigator who is trained to engage patients in advance care planning.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 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
- NCT03856463
- Sponsor's protocol ID
- Stanford12
- Acronym
- CAREPlan
- Status last verified
- Mar 2024
- First submitted
- 22 Feb 2019
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rodriguez GM, Parikh DA, Kapphahn K, Gupta DM, Fan AC, Shah S, Srinivas S, Teuteberg W, Seevaratnam B, Asuncion K, Chien J, Moore K, Ruiz SM, Patel MI. Coaches Activating, Reaching, and Engaging Patients to Engage in Advance Care Planning: A Randomized Clinical Trial. JAMA Oncol. 2024 Jul 1;10(7):949-953. doi: 10.1001/jamaoncol.2024.1242.
PubMed 38780960
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAREPlan: Coaches Activating, Reaching, and Engaging Patients in End-of-Life Care Plan
- ClinicalTrials.gov ID
- NCT03856463
- Acronym / sponsor ID
- CAREPlan / Stanford12
- Conditions
- Cancer, End-of-Life
- Keywords
- end of life, quality of care, cancer care delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 3 Apr 2019 (actual)
- Primary completion
- 3 Apr 2023 (actual)
- Study completion
- 25 Sep 2023 (actual)
- First posted
- 27 Feb 2019 (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 purpose of the Team Based Advance Care Planning CAREPLAN program is to understand if a trained lay navigator who engages with patients with advanced stages of cancer can help patients in advance care planning, improve patient activation, satisfaction, quality of life, and the quality of end of life cancer care while also ensuring goal concordant cancer care at the end of life.
Detailed description
Stanford Cancer Institute plans to implement and evaluate several critical elements to be in alignment with the mission of the organization to provide high value care to their patients. The CAREPLAN (Coaches Activating, Reaching, and Engaging Patients in Their End of Life Care Plan) intervention is an innovative program aimed to strengthen provider-patient relationships and facilitate whole person care about matters important to patients diagnosed with advanced stages of cancer and important to patients' support network and family. The project is intended to help establish patients' Goals of Care Plan with appropriate documentation, develop, deploy, and evaluate a model of care for patients with cancer that is intended to improve clinical outcomes and their experiences with their cancer care. The intervention provides patients with lay navigators who assist them and their families in formulating and discussing their goals of care with their health care teams in hopes to engage in shared-decision making for goal concordant care. The goal of the project is to demonstrate that there is improved documentation of goals of care, patient experiences, patient activation, quality of life, and quality of care and communication and that the program helps to improve goal concordant care receipt at the end of life.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- As part of usual care, patients with cancer are assigned to services by a lay navigator and this will be the control group. For patients in the intervention, they will be assigned to the usual care lay navigator but will receive services by a lay navigator who is trained to engage patients in advance care planning.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group Arm | Experimental | Behavioral: Lay Navigator Intervention, Other: Usual CarePatients randomized into the intervention will be assigned a lay patient navigator who will provide information regarding early advance care planning, documentation of goals of care, and coordinating home-based care. The intervention arm will also receive usual care as provided by their local oncologists. |
| Control Group Arm | Active comparator | Other: Usual CareThe control group will receive usual care as provided by 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 (1 listed)
- All patients who receive care at Stanford Cancer Institute and have genitourinary cancers and have received greater than 2 prior courses of chemotherapy treatment
Key exclusion criteria (1 listed)
- Patients without capacity to consent
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 Navigator InterventionAlso: Intervention Group ArmPatients 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 and documenting goals of care. | Behavioural | Intervention Group Arm |
| Usual CareUsual care as provided by local oncologists | Other | Control Group Arm, Intervention Group Arm |
Primary outcome
Goals of Care Documentation
Time frame: 12 months after patient enrollment
Goals of Care documentation for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.
4 secondary outcomes
Emergency Department Visit using chart abstraction
Time frame: 12 months after patient enrollment
Hospitalization Visit using chart abstraction
Time frame: 12 months after patient enrollment
Palliative care using chart abstraction
Time frame: 12 months after patient enrollment
Hospice using chart abstraction
Time frame: 12 months after patient 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 21 Mar 2024.
- Derived from this study: PubMed 38780960Rodriguez GM, Parikh DA, Kapphahn K, Gupta DM, Fan AC, Shah S, Srinivas S, Teuteberg W, Seevaratnam B, Asuncion K, Chien J, Moore K, Ruiz SM, Patel MI. Coaches Activating, Reaching, and Engaging Patients to Engage in Advance Care Planning: A Randomized Clinical Trial. JAMA Oncol. 2024 Jul 1;10(7):949-953. doi: 10.1001/jamaoncol.2024.1242.
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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.
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 Navigator Intervention in people with Cancer and End-of-Life, 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 1 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 21 Mar 2024. 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?
Goals of Care Documentation (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?
On the ClinicalTrials.gov record for NCT03856463, 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 21 Mar 2024.