Lay Health Worker Engage, Educate, and Encourage Patients to Share

NCT03699748 | Completed Results

• 2 other identifiers: 40447K23MD013474-01
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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 healthcare resource utilization.

Conditions

End of Life; Cancer

Keywords

cancer; end of life; patient-centered

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  Change in Patient Activation Measure from baseline to 4 months post enrollment.

• Patient Activation Using the Patient Activation Measure Survey

  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

  Health-related quality of life at 12 months

Study Arms (2)

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.

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.

Other: Usual Care

Interventions

Lay Health Worker Intervention 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, 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.

Intervention Group Arm

Usual Care OTHER

Usual care as provided by Unite Here Health and local oncologists

Control Group Arm; Intervention Group Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (2)

• 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.

  PMID: 37625110 DERIVED

• Patel 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.

  PMID: 32145441 DERIVED

MeSH Terms

Conditions

Death; Neoplasms

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Manali Patel
• Organization: Stanford University

manalip@stanford.edu

6504859462

Study Officials

• Manali I Patel, MD MPH MS

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: October 9, 2018
• Study Start: November 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 30, 2022
• Last Updated: July 7, 2023
• Results First Posted: July 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)