NCT06285929

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 29, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 29, 2024

Status Verified

February 1, 2024

Enrollment Period

2 years

First QC Date

February 6, 2024

Last Update Submit

February 22, 2024

Conditions

Keywords

Patient NavigationPatient SatisfactionPatient EngagementPatient EmpowermentPatient ParticipationTreatment Adherance

Outcome Measures

Primary Outcomes (11)

  • 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 Outcomes (3)

  • 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 Arms (3)

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

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

Interventions

Student volunteers providing navigation support to patients, families and caregivers with a cancer diagnosis through an SDOH assessment.

Navigated patientsStudent volunteers

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

UCLA Health

Los Angeles, California, 90024, United States

Location

American Cancer Society

Kennesaw, Georgia, 30144, United States

Location

University of Iowa Health Care

Iowa City, Iowa, 52242, United States

Location

Medical University Hospital Authority, Hollings Cancer Center

Charleston, South Carolina, 29492, United States

Location

MeSH Terms

Conditions

NeoplasmsPatient SatisfactionPatient Participation

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehaviorPatient Acceptance of Health Care

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Director, ACS CARES

Study Record Dates

First Submitted

February 6, 2024

First Posted

February 29, 2024

Study Start

September 1, 2023

Primary Completion

August 31, 2025

Study Completion

December 31, 2025

Last Updated

February 29, 2024

Record last verified: 2024-02

Locations