Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03699748
Other study ID # 40447
Secondary ID K23MD013474-01
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2018
Est. completion date December 30, 2022

Study information

Verified date July 2023
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 healthcare resource utilization.


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.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date December 30, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Newly diagnosed patients with a cancer diagnosis. 2. Patients with any relapse or progressive disease (any cancer diagnosis) as identified by imaging or biopsy and confirmed by physician. 3. The patients must be 18 years or older. 4. Patients must have the capacity to verbally consent. Exclusion Criteria: 1. Inability to consent to the study due to lack of capacity as documented by the referring physician. 2. Patients without a newly diagnosed malignancy or patients without relapse of disease. 3. Patients not eligible for Fund benefits. Patients without a newly diagnosed malignancy or patients without relapse of disease.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Lay Health Worker 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, 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.
Other:
Usual Care
Usual care as provided by Unite Here Health and local oncologists

Locations

Country Name City State
United States Stanford University School of Medicine Stanford California

Sponsors (3)

Lead Sponsor Collaborator
Stanford University National Institute on Minority Health and Health Disparities (NIMHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. Proportion of patients who strongly agree that decisions about their health care were theirs to make at 4 months post study enrollment.
Secondary 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. Proportion of patients who strongly agree that decisions about their health care were theirs to make at 12 months post study enrollment.
Secondary 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. Change in Patient Activation Measure from baseline to 4 months post enrollment.
Secondary 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. Change in Patient Activation Measure from baseline to 12 months post-enrollment.
Secondary 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. Health-related quality of life at 12 months
Secondary 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. 4 months after patient enrollment
Secondary 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. 12 months after patient enrollment
Secondary 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. Last 30 days of life up to 12 months from patient enrollment
Secondary 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. 4 months after patient enrollment
Secondary 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. 12 months after study enrollment
Secondary 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. last 30 days of life
Secondary 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. 4 months after patient enrollment
Secondary 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. 12 months after patient enrollment
Secondary 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. 4 months after patient enrollment
Secondary 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. 12 months after patient enrollment
Secondary 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. 4 months after patient enrollment
Secondary 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. 12 months after patient enrollment
Secondary 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 12 months after patient enrollment
Secondary 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. Last 30 days of life up to 12 months from patient enrollment
Secondary 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. 4 months after patient enrollment
Secondary 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. 12 months after patient enrollment
Secondary 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. last 30 days of life
Secondary 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. 4 months after patient enrollment
Secondary 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. 12 months after patient enrollment
Secondary 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. last 30 days of life
Secondary Survival (Chart Review) Survival rate for patients will be abstracted by electronic medical record chart review at 4 months after enrollment. 4 months after patient enrollment
Secondary Survival (Chart Review) Survival rate for patients will be abstracted by electronic medical record chart review at 12 months after enrollment. 12 months after patient enrollment
Secondary 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. Proportion of patients who strongly agreed the decisions about their health care were theirs to make at baseline (study enrollment).
See also
  Status Clinical Trial Phase
Recruiting NCT05346796 - Survivorship Plan HEalth REcord (SPHERE) Implementation Trial N/A
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Completed NCT04867850 - Effect of Behavioral Nudges on Serious Illness Conversation Documentation N/A
Enrolling by invitation NCT04086251 - Remote Electronic Patient Monitoring in Oncology Patients N/A
Completed NCT01285037 - A Study of LY2801653 in Advanced Cancer Phase 1
Completed NCT00680992 - Study of Denosumab in Subjects With Giant Cell Tumor of Bone Phase 2
Completed NCT00062842 - Study of Irinotecan on a Weekly Schedule in Children Phase 1
Active, not recruiting NCT04548063 - Consent Forms in Cancer Research: Examining the Effect of Length on Readability N/A
Completed NCT04337203 - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship N/A
Recruiting NCT04349293 - Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways N/A
Terminated NCT02866851 - Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy N/A
Active, not recruiting NCT05304988 - Development and Validation of the EFT for Adolescents With Cancer
Completed NCT00340522 - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Completed NCT03109041 - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source Phase 1
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Recruiting NCT06206785 - Resting Energy Expenditure in Palliative Cancer Patients
Recruiting NCT05318196 - Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases