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

February 22, 2024 updated by: Bonny Morris, American Cancer Society, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Measure the impact of ACS CARES on patient-reported outcomes: SDOH barriers
Time Frame: Baseline and 6 months into pilot
SDOH barriers
Baseline and 6 months into pilot
Measure the impact of ACS CARES on patient-reported outcomes: Information Needs
Time Frame: Baseline and 6 months into pilot
Information Needs
Baseline and 6 months into pilot
Measure the impact of ACS CARES on patient-reported outcomes: Distress needs
Time Frame: Baseline and 6 months into pilot
Distress needs
Baseline and 6 months into pilot
Measure the impact of ACS CARES on patient-reported outcomes: Satisfaction with program
Time Frame: Baseline and 6 months into pilot
Satisfaction with program
Baseline and 6 months into pilot
Measure the impact of ACS CARES on patient-reported outcomes: Unmet needs
Time Frame: Baseline and 6 months into pilot
Unmet needs
Baseline and 6 months into pilot
Measure the impact of ACS CARES on patient-reported outcomes: Patient-provider communication
Time Frame: Baseline and 6 months into pilot
Patient-provider communication
Baseline and 6 months into pilot
Measure the impact of ACS CARES on patient-reported outcomes: clinical trials knowledge
Time Frame: Baseline and 6 months into pilot
clinical trials knowledge
Baseline and 6 months into pilot
Measure the impact of ACS CARES on patient-reported outcomes: Patient activation
Time Frame: Baseline and 6 months into pilot
Patient activation
Baseline and 6 months into pilot
Measure the impact of ACS CARES on patient-reported outcomes: Financial toxicity
Time Frame: Baseline and 6 months into pilot
Financial toxicity
Baseline and 6 months into pilot
Measure the impact of ACS CARES on patient-reported outcomes: Quality of life
Time Frame: Baseline and 6 months into pilot
Quality of life
Baseline and 6 months into pilot
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
through study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sociodemographic differences between ACS CARES supported and non-ACS CAREs supported patients
Time Frame: baseline and 1 year
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
Time Frame: baseline and 1 year
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
Time Frame: 1 year
Volunteer Satisfaction Index
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
American Cancer Society, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 29, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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