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Clinical Trials/NCT06285929
NCT06285929
Enrolling By Invitation
Not Applicable

Community Engagement in the Development of Oncology Navigation Training

American Cancer Society, Inc.4 sites in 1 country2,000 target enrollmentSeptember 1, 2023
ConditionsNeoplasms

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neoplasms
Sponsor
American Cancer Society, Inc.
Enrollment
2000
Locations
4
Primary Endpoint
Measure the impact of ACS CARES on patient-reported outcomes: Information Needs
Status
Enrolling By Invitation
Last Updated
2 years ago

Overview

Brief Summary

The goal of this study is to evaluate the pilot phase of ACS Cares to identify key implementation outcomes and assess effectiveness of the program to improve distress, enhance communication, and reduce missed appointments and healthcare utilization.

Detailed Description

In 2023, the American Cancer Society (ACS) created a new program, ACS Cares, based on the Take the Fight experience and existing literature on non-clinical navigation. The goal of ACS Cares is to supplement existing navigation infrastructure to extend navigation services to a broader population of patients. This is accomplished through designating lower level, timely tasks to volunteers and allowing paid navigators to practice at the highest level of their license (e.g nurses proving symptom management, higher level coordination). The goal of this study is to evaluate the pilot phase of ACS Cares to identify key implementation outcomes and assess effectiveness of the program to improve distress, enhance communication, and reduce missed appointments and healthcare utilization.

Registry
clinicaltrials.gov
Start Date
September 1, 2023
End Date
December 31, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bonny Morris

Senior Director, ACS CARES

American Cancer Society, Inc.

Eligibility Criteria

Inclusion Criteria

  • patients of health system's healthcare physician champions with a confirmed cancer diagnosis
  • patients with a confirmed cancer diagnosis
  • families of patients with a confirmed cancer diagnosis
  • Caregivers of patients with a confirmed cancer diagnosis

Exclusion Criteria

  • patients, families and/or caregivers without a confirmed cancer diagnosis
  • patients not receiving care from healthcare physician champions

Outcomes

Primary Outcomes

Measure the impact of ACS CARES on patient-reported outcomes: Information Needs

Time Frame: Baseline and 6 months into pilot

Information Needs

Measure the impact of ACS CARES on patient-reported outcomes: Quality of life

Time Frame: Baseline and 6 months into pilot

Quality of life

Measure the impact of ACS CARES on patient-reported outcomes: SDOH barriers

Time Frame: Baseline and 6 months into pilot

SDOH barriers

Measure the impact of ACS CARES on patient-reported outcomes: Distress needs

Time Frame: Baseline and 6 months into pilot

Distress needs

Measure the impact of ACS CARES on patient-reported outcomes: Unmet needs

Time Frame: Baseline and 6 months into pilot

Unmet needs

Measure the impact of ACS CARES on patient-reported outcomes: Patient-provider communication

Time Frame: Baseline and 6 months into pilot

Patient-provider communication

Measure the impact of ACS CARES on patient-reported outcomes: clinical trials knowledge

Time Frame: Baseline and 6 months into pilot

clinical trials knowledge

Measure the impact of ACS CARES on patient-reported outcomes: Patient activation

Time Frame: Baseline and 6 months into pilot

Patient activation

Context, Training, and Process Measures: Service Penetrance and Process Measures: Service Penetrance

Time Frame: through study completion, an average of 1 year

• # of patients/caregivers approached for ACS CARES Median and range per volunteer • # of patients/caregivers who decline by refusal reason • # of patients/caregivers supported by ACS CARES Median and range per volunteer • # of patients/caregivers who received psychosocial distress screening Median and range per ACS CARES volunteer • # of patients/caregivers who received an SDOH screening Median and range per ACS CARES volunteer • # of follow-ups conducted Median and range per ACS CARES volunteer • # of in-person visits conducted Median and range per ACS CARES volunteer • # of shifts completed Median and range per ACS CARES volunteer • # of referrals received from health system team members

Measure the impact of ACS CARES on patient-reported outcomes: Satisfaction with program

Time Frame: Baseline and 6 months into pilot

Satisfaction with program

Measure the impact of ACS CARES on patient-reported outcomes: Financial toxicity

Time Frame: Baseline and 6 months into pilot

Financial toxicity

Secondary Outcomes

  • Sociodemographic differences between ACS CARES supported and non-ACS CAREs supported patients(baseline and 1 year)
  • Impact of ACS CARES on treatment adherence and healthcare(baseline and 1 year)
  • Context, Training, and Process Measures: Volunteer Satisfaction(1 year)

Study Sites (4)

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