NeoplasmsACS CARESNCT06285929
ACS Community Access to Resources Education and Support
An observational study of Neoplasms, run by American Cancer Society, Inc. at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Neoplasms
- What is being tested?
- ACS CARES Student Navigation
- How many people
- 2,000 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Sep 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: patients, families and/or caregivers with a confirmed cancer diagnosis
Who may be able to join
- 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
Who cannot join
- patients, families and/or caregivers without a confirmed cancer diagnosis
- patients not receiving care from healthcare physician champions
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Medical University Hospital Authority, Hollings Cancer Center
Charleston, South Carolina, 29492
University of Iowa Health Care
Iowa City, Iowa, 52242
American Cancer Society
Kennesaw, Georgia, 30144
UCLA Health
Los Angeles, California, 90024
About this study
Official title: 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.
Read the 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.
- Conditions
- Neoplasms
- Being tested
- ACS CARES Student Navigation
- Keywords
- Patient Navigation, Patient Satisfaction, Patient Engagement, Patient Empowerment, Patient Participation, Treatment Adherance
- Medical subject headings
- Neoplasms, Patient Satisfaction, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACS CARES Student NavigationOther
Student volunteers providing navigation support to patients, families and caregivers with a cancer diagnosis through an SDOH assessment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: ACS CARES Student Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the impact of ACS CARES on patient-reported outcomes: SDOH barriers
SDOH barriers
Measured: Baseline and 6 months into pilot
Measure the impact of ACS CARES on patient-reported outcomes: Information Needs
Information Needs
Measured: Baseline and 6 months into pilot
Measure the impact of ACS CARES on patient-reported outcomes: Distress needs
Distress needs
Measured: Baseline and 6 months into pilot
Measure the impact of ACS CARES on patient-reported outcomes: Satisfaction with program
Satisfaction with program
Measured: Baseline and 6 months into pilot
Measure the impact of ACS CARES on patient-reported outcomes: Unmet needs
Unmet needs
Measured: Baseline and 6 months into pilot
Measure the impact of ACS CARES on patient-reported outcomes: Patient-provider communication
Patient-provider communication
Measured: Baseline and 6 months into pilot
Measure the impact of ACS CARES on patient-reported outcomes: clinical trials knowledge
clinical trials knowledge
Measured: Baseline and 6 months into pilot
Measure the impact of ACS CARES on patient-reported outcomes: Patient activation
Patient activation
Measured: Baseline and 6 months into pilot
Measure the impact of ACS CARES on patient-reported outcomes: Financial toxicity
Financial toxicity
Measured: Baseline and 6 months into pilot
Measure the impact of ACS CARES on patient-reported outcomes: Quality of life
Quality of life
Measured: 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
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
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)
Measured: 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.
Measured: baseline and 1 year
Context, Training, and Process Measures: Volunteer Satisfaction
Volunteer Satisfaction Index
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start1 Sep 2023
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American Cancer Society, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Responsible party
- Principal investigator, Bonny Morris, American Cancer Society, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285929
- Sponsor's protocol ID
- 2013209-1
- Acronym
- ACS CARES
- Status last verified
- Feb 2024
- First submitted
- 6 Feb 2024
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Engagement in the Development of Oncology Navigation Training
- ClinicalTrials.gov ID
- NCT06285929
- Acronym / sponsor ID
- ACS CARES / 2013209-1
- Conditions
- Neoplasms
- Keywords
- Patient Navigation, Patient Satisfaction, Patient Engagement, Patient Empowerment, Patient Participation, Treatment Adherance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- American Cancer Society, Inc.University, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Navigated patients | – | Other: ACS CARES Student NavigationStudent 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. |
| 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 | – | Other: ACS CARES Student NavigationUndergraduate or graduate students volunteering with ACS CARES program to provide navigation support to patients, families and caregivers with a cancer diagnosis. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients, families and/or caregivers with a confirmed cancer diagnosis
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- patients, families and/or caregivers without a confirmed cancer diagnosis
- patients not receiving care from healthcare physician champions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACS CARES Student NavigationStudent volunteers providing navigation support to patients, families and caregivers with a cancer diagnosis through an SDOH assessment. | Other | Navigated patients, Student volunteers |
Primary outcome
Measure the impact of ACS CARES on patient-reported outcomes: SDOH barriers
Time frame: Baseline and 6 months into pilot
SDOH barriers
Measure the impact of ACS CARES on patient-reported outcomes: Information Needs
Time frame: Baseline and 6 months into pilot
Information Needs
Measure the impact of ACS CARES on patient-reported outcomes: Distress needs
Time frame: Baseline and 6 months into pilot
Distress needs
Measure the impact of ACS CARES on patient-reported outcomes: Satisfaction with program
Time frame: Baseline and 6 months into pilot
Satisfaction with program
Measure the impact of ACS CARES on patient-reported outcomes: Unmet needs
Time frame: Baseline and 6 months into pilot
Unmet needs
Measure the impact of ACS CARES on patient-reported outcomes: Patient-provider communication
Time frame: Baseline and 6 months into pilot
Patient-provider communication
Measure the impact of ACS CARES on patient-reported outcomes: clinical trials knowledge
Time frame: Baseline and 6 months into pilot
clinical trials knowledge
Measure the impact of ACS CARES on patient-reported outcomes: Patient activation
Time frame: Baseline and 6 months into pilot
Patient activation
Measure the impact of ACS CARES on patient-reported outcomes: Financial toxicity
Time frame: Baseline and 6 months into pilot
Financial toxicity
Measure the impact of ACS CARES on patient-reported outcomes: Quality of life
Time frame: Baseline and 6 months into pilot
Quality of life
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
3 secondary outcomes
Sociodemographic differences between ACS CARES supported and non-ACS CAREs supported patients
Time frame: baseline and 1 year
Impact of ACS CARES on treatment adherence and healthcare
Time frame: baseline and 1 year
Context, Training, and Process Measures: Volunteer Satisfaction
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Neoplasms
Enrolling by invitation
Exercise Intervention for Breast Cancer Patients With Sarcopenia
Sarcopenia, Breast Cancer
RecruitingPhase 3
A Study Comparing TAK-928 With Docetaxel in Adults With Non-Small Cell Lung Cancer
IO Resistant Squamous and Nonsquamous NSCLC
Not yet recruitingPhase 2
Saruparib in HRDsig+ Solid Tumors
Malignant Neoplastic Disease (Disorder)
RecruitingPhase 2
IGFBP-2 Vaccine to Prevent Ovarian Cancer Progression in Patients With Serologic Detection of Recurrence
Fallopian Tube Carcinoma, Ovarian Carcinoma
Not yet recruitingPhase 2
Nemtabrutinib for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) Refractory to Covalent Bruton Tyrosine Kinase Inhibitor or Pirtobrutinib and Previously Treated With a BCL2 Inhibitor
Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms, run by American Cancer Society, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the impact of ACS CARES on patient-reported outcomes: SDOH barriers (time frame: Baseline and 6 months into pilot). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.