ACS Community Access to Resources Education and Support

Neoplasms Clinical Trial

— ACS CARES  

Official title:

Community Engagement in the Development of Oncology Navigation Training

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06285929
• Other study ID #: 2013209-1
• Status: Enrolling by invitation
• Start date: September 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: American Cancer Society, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2000
• Est. completion date: December 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

Other:
• ACS CARES Student Navigation
Student volunteers providing navigation support to patients, families and caregivers with a cancer diagnosis through an SDOH assessment.

Locations

Country	Name	City	State
United States	Medical University Hospital Authority, Hollings Cancer Center	Charleston	South Carolina
United States	University of Iowa Health Care	Iowa City	Iowa
United States	American Cancer Society	Kennesaw	Georgia
United States	UCLA Health	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
American Cancer Society, Inc.	University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the impact of ACS CARES on patient-reported outcomes: SDOH barriers	SDOH barriers	Baseline and 6 months into pilot
Primary	Measure the impact of ACS CARES on patient-reported outcomes: Information Needs	Information Needs	Baseline and 6 months into pilot
Primary	Measure the impact of ACS CARES on patient-reported outcomes: Distress needs	Distress needs	Baseline and 6 months into pilot
Primary	Measure the impact of ACS CARES on patient-reported outcomes: Satisfaction with program	Satisfaction with program	Baseline and 6 months into pilot
Primary	Measure the impact of ACS CARES on patient-reported outcomes: Unmet needs	Unmet needs	Baseline and 6 months into pilot
Primary	Measure the impact of ACS CARES on patient-reported outcomes: Patient-provider communication	Patient-provider communication	Baseline and 6 months into pilot
Primary	Measure the impact of ACS CARES on patient-reported outcomes: clinical trials knowledge	clinical trials knowledge	Baseline and 6 months into pilot
Primary	Measure the impact of ACS CARES on patient-reported outcomes: Patient activation	Patient activation	Baseline and 6 months into pilot
Primary	Measure the impact of ACS CARES on patient-reported outcomes: Financial toxicity	Financial toxicity	Baseline and 6 months into pilot
Primary	Measure the impact of ACS CARES on patient-reported outcomes: Quality of life	Quality of life	Baseline and 6 months into pilot
Primary	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	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
Secondary	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
Secondary	Context, Training, and Process Measures: Volunteer Satisfaction	Volunteer Satisfaction Index	1 year