Clinical trial NCT06285929: ACS Community Access to Resources Education and Support
Official title: Community Engagement in the Development of Oncology Navigation Training
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Neoplasms
Keywords: Patient Navigation
Patient Satisfaction
Patient Engagement
Patient Empowerment
Patient Participation
Treatment Adherance
Lead sponsor: American Cancer Society, Inc.
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
First posted: 2024-02-29
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients, families and/or caregivers with a confirmed cancer diagnosis

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.

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

Primary outcomes:
measure: Measure the impact of ACS CARES on patient-reported outcomes: SDOH barriers
timeFrame: Baseline and 6 months into pilot
measure: Measure the impact of ACS CARES on patient-reported outcomes: Information Needs
timeFrame: Baseline and 6 months into pilot
measure: Measure the impact of ACS CARES on patient-reported outcomes: Distress needs
timeFrame: Baseline and 6 months into pilot
measure: Measure the impact of ACS CARES on patient-reported outcomes: Satisfaction with program
timeFrame: Baseline and 6 months into pilot
measure: Measure the impact of ACS CARES on patient-reported outcomes: Unmet needs
timeFrame: Baseline and 6 months into pilot
measure: Measure the impact of ACS CARES on patient-reported outcomes: Patient-provider communication
timeFrame: Baseline and 6 months into pilot
measure: Measure the impact of ACS CARES on patient-reported outcomes: clinical trials knowledge
timeFrame: Baseline and 6 months into pilot
measure: Measure the impact of ACS CARES on patient-reported outcomes: Patient activation
timeFrame: Baseline and 6 months into pilot
measure: Measure the impact of ACS CARES on patient-reported outcomes: Financial toxicity
timeFrame: Baseline and 6 months into pilot
measure: Measure the impact of ACS CARES on patient-reported outcomes: Quality of life
timeFrame: Baseline and 6 months into pilot
measure: Context, Training, and Process Measures: Service Penetrance and Process Measures: Service Penetrance
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Sociodemographic differences between ACS CARES supported and non-ACS CAREs supported patients
timeFrame: baseline and 1 year
measure: Impact of ACS CARES on treatment adherence and healthcare
timeFrame: baseline and 1 year
measure: Context, Training, and Process Measures: Volunteer Satisfaction
timeFrame: 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Health
state: California
city: Kennesaw
country: United States
facility: American Cancer Society
state: Georgia
city: Iowa City
country: United States
facility: University of Iowa Health Care
state: Iowa
city: Charleston
country: United States
facility: Medical University Hospital Authority, Hollings Cancer Center
state: South Carolina
Study officials:
References: