Coaches Activating Reaching and Engaging Patients

NCT ID: NCT03856463

Last Updated: 2024-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-03

Study Completion Date

2023-09-25

Brief Summary

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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

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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

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Cancer End-of-Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention Group Arm

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.

Group Type EXPERIMENTAL

Lay Navigator Intervention

Intervention Type BEHAVIORAL

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 Care

Intervention Type OTHER

Usual care as provided by local oncologists

Control Group Arm

The control group will receive usual care as provided by their local oncologists.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

Usual care as provided by local oncologists

Interventions

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Lay Navigator Intervention

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.

Intervention Type BEHAVIORAL

Usual Care

Usual care as provided by local oncologists

Intervention Type OTHER

Other Intervention Names

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Intervention Group Arm

Eligibility Criteria

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Inclusion Criteria

* All patients who receive care at Stanford Cancer Institute and have genitourinary cancers and have received greater than 2 prior courses of chemotherapy treatment

Exclusion Criteria

* Patients without capacity to consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Manali Indravadan Patel

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38780960 (View on PubMed)

Other Identifiers

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Stanford12

Identifier Type: -

Identifier Source: org_study_id

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