ACS Community Access to Resources Education and Support (ACS CARES)

Community Engagement in the Development of Oncology Navigation Training

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Neoplasms
• Intervention / Treatment: Other: ACS CARES Student Navigation

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.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90024
      • UCLA Health
  • Georgia
    • Kennesaw, Georgia, United States, 30144
      • American Cancer Society
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Health Care
  • South Carolina
    • Charleston, South Carolina, United States, 29492
      • Medical University Hospital Authority, Hollings Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

patients, families and/or caregivers with a confirmed cancer diagnosis

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Navigated patients; Student volunteer navigation support accessing barriers to care for patients, families and caregivers with a cancer diagnosis through a social determinants of health assessment and connecting with resources with an effort to eliminate barriers.	Other: ACS CARES Student Navigation; Student volunteers providing navigation support to patients, families and caregivers with a cancer diagnosis through an SDOH assessment.
non-navigated patients; Patients, families and caregivers with a cancer diagnosis without the support of student volunteer navigation and serving as the baseline and control.
Student volunteers; Undergraduate or graduate students volunteering with ACS CARES program to provide navigation support to patients, families and caregivers with a cancer diagnosis.	Other: ACS CARES Student Navigation; Student volunteers providing navigation support to patients, families and caregivers with a cancer diagnosis through an SDOH assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure the impact of ACS CARES on patient-reported outcomes: SDOH barriers	SDOH barriers	Baseline and 6 months into pilot
Measure the impact of ACS CARES on patient-reported outcomes: Information Needs	Information Needs	Baseline and 6 months into pilot
Measure the impact of ACS CARES on patient-reported outcomes: Distress needs	Distress needs	Baseline and 6 months into pilot
Measure the impact of ACS CARES on patient-reported outcomes: Satisfaction with program	Satisfaction with program	Baseline and 6 months into pilot
Measure the impact of ACS CARES on patient-reported outcomes: Unmet needs	Unmet needs	Baseline and 6 months into pilot
Measure the impact of ACS CARES on patient-reported outcomes: Patient-provider communication	Patient-provider communication	Baseline and 6 months into pilot
Measure the impact of ACS CARES on patient-reported outcomes: clinical trials knowledge	clinical trials knowledge	Baseline and 6 months into pilot
Measure the impact of ACS CARES on patient-reported outcomes: Patient activation	Patient activation	Baseline and 6 months into pilot
Measure the impact of ACS CARES on patient-reported outcomes: Financial toxicity	Financial toxicity	Baseline and 6 months into pilot
Measure the impact of ACS CARES on patient-reported outcomes: Quality of life	Quality of life	Baseline and 6 months into pilot
Context, Training, and Process Measures: Service Penetrance and Process Measures: Service Penetrance	• # 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	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sociodemographic differences between ACS CARES supported and non-ACS CAREs supported patients	Patient characteristics: age, sex, gender (if available), race, ethnicity, insurance status, zip code, urban or rural residence, Area Deprivation Index category, and distance from cancer center (<30 minutes, 30-60 minutes, >60 minutes)	baseline and 1 year
Impact of ACS CARES on treatment adherence and healthcare	Cancer and treatment characteristics: cancer type, date of diagnosis, type of current treatment (Surgery, Chemotherapy, Radiation Therapy, Targeted Therapy, Immunotherapy, Stem Cell or Bone Marrow Transplant, Hormone Therapy), total clinic appointments, # clinic appts missed/cancelled, total infusion appointments, # infusion appointments missed/cancelled, total radiation treatment appts, # radiation treatment appointments missed/cancelled, enrolled in a clinical trial (y/n), start date of clinical trial participation, ER visits, hospitalizations, ICU admissions, total cost of care. For new patients during baseline or intervention time periods, date of first clinic visit.	baseline and 1 year
Context, Training, and Process Measures: Volunteer Satisfaction	Volunteer Satisfaction Index	1 year

Collaborators and Investigators

• Sponsor: American Cancer Society, Inc.
• Collaborators: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 6, 2024
• First Submitted That Met QC Criteria: February 22, 2024
• First Posted (Estimated): February 29, 2024

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Patient Navigation; Patient Participation; Patient Satisfaction; Patient Engagement; Patient Empowerment; Treatment Adherance
• Other Study ID Numbers: 2013209-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No