CARES Program for Cancer

(CARES Trial)

Overseen By Jennifer L Steel, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Thought disorder, Delusions, Hallucinations, Suicidal ideation

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

1750 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach called CARES, which aims to improve cancer treatment by integrating screening and personalized care. The goal is to assess the effectiveness of CARES and identify factors that help or hinder its implementation. Participants will receive either standard care or the new CARES intervention to compare results. The trial seeks individuals diagnosed with cancer who can read and write in English to determine the best way to support patients in their cancer journey. As an unphased trial, this study offers participants the chance to contribute to innovative cancer care solutions that could enhance patient support.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the CARES program is safe?

Research has shown that the CARES treatment, which includes screening and team-based care for cancer patients, has undergone testing before. In previous studies, participants who received CARES did not report major safety issues. These studies compared CARES to the usual care provided in cancer centers.

The results suggest that CARES was well-tolerated, with most participants not experiencing serious side effects. The research examined the impact of CARES on both patients and their caregivers and did not identify any new safety concerns.

While these studies provide a strong foundation, ongoing research remains essential to confirm safety. Prospective participants should consult their healthcare provider before joining a clinical trial to ensure it is appropriate for them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CARES Program for Cancer because it integrates screening with a stepped collaborative care intervention, a novel approach in cancer care. Unlike the standard of care that often involves separate screening and treatment processes, CARES emphasizes a seamless integration designed to enhance patient engagement and outcomes. This method aims to streamline the patient journey, potentially improving access to care and support while reducing delays in treatment. The hope is that this holistic approach will lead to better overall patient satisfaction and outcomes, making the treatment process more efficient and effective.

What evidence suggests that the CARES program is effective for cancer care?

Research has shown that value-based care models in cancer treatment, such as the CARES program studied in this trial, can improve patient outcomes by emphasizing personalized and efficient healthcare. This trial compares the CARES program, which includes an Integrated Screening and Stepped Collaborative Care Intervention, with the Standard of Care (SOC), which involves integrated screening and referral to treatment in the community and/or at the cancer center. Studies have found that addressing all aspects of cancer care leads to better quality and results for patients. A review of self-management programs for cancer patients indicates they can improve quality of life and confidence in managing their own care. Reports from doctors using similar care models show higher rates of therapy completion and fewer complications. These findings suggest that the CARES program could enhance the overall treatment experience for cancer patients. ^{6 7 8 9 10}

Who Is on the Research Team?

Jennifer L Steel, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for English-reading adults aged 18 or older who have been diagnosed with cancer. It's not suitable for individuals showing signs of delusions, suicidal ideation with a plan, thought disorders, or hallucinations.

Inclusion Criteria

Ability to read and write in English

I am 18 years old or older.

I have been diagnosed with cancer.

Exclusion Criteria

Evidence of delusions

Evidence of suicidal ideation with a plan

I have been diagnosed with a thought disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the CARES intervention, an integrated screening and stepped collaborative care intervention

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CARES

Trial Overview The study is testing CARES, an intervention that combines screening and stepped collaborative care against the usual standard of care in cancer patients to see how effective it is and what helps or hinders its use.

How Is the Trial Designed?

Group I: CARES Experimental Treatment 1 Intervention

Integrated Screening and Stepped Collaborative Care Intervention

Group II: Standard of Care (SOC) Active Control 1 Intervention

Integrated screening and referred to treatment in the community and/or at the cancer center

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e13865

Descriptive analysis of the PCP-ONC CARES Program PCP-ONC CARES patients died at an increased frequency (0.3% / <0.1%, vs 0.6%). Conclusions: The PCP-ONC CARES program enrolls a distinct ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3170062/

Benchmarks for Value in Cancer Care: An Analysis of a ... Comprehensive cancer solutions to address the full spectrum of care will facilitate improved quality and patient outcomes.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2822297

Patient-Reported Outcome Measures in Cancer Care Clinician-reported outcomes included mortality, therapy completion, and therapy complications. Health care utilization outcomes included number ...

4. ama-assn.org ama-assn.org/practice-management/payment-delivery-models/value-based-care-oncology-keep-these-metrics-mind

For value-based care in oncology, keep these metrics in mind In oncology, value-based care means transforming patient outcomes by emphasizing personalized and efficient health care.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2451865424001340

Feasibility of self-monitoring and community health worker ... A systematic review of self-management programs among prostate cancer patients suggested positive effects on quality of life and self-efficacy, but study ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11556417/

Patient, family caregiver, and economic outcomes of an ... This study aimed to test the efficacy of an integrated screening and novel stepped collaborative care intervention versus standard of care (ie, ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38490230/

Patient, family caregiver, and economic outcomes of ... - PubMed This trial aimed to test the efficacy of an integrated screening and novel stepped collaborative care intervention versus standard of care for patients with ...

8. researchgate.net researchgate.net/publication/378914787_Patient_family_caregiver_and_economic_outcomes_of_an_integrated_screening_and_novel_stepped_collaborative_care_intervention_in_the_oncology_setting_in_the_USA_CARES_a_randomised_parallel_phase_3_trial

Patient, family caregiver, and economic outcomes of an ... Patient, family caregiver, and economic outcomes of an integrated screening and novel stepped collaborative care intervention in the oncology setting in the USA ...

9. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/pon.9307

Walking the Talk: “Reflexivity” to Advance Integration of ... In this commentary, we propose the use of video-reflexive ethnography (VRE) as a means to support integration of patient-reported outcomes ...

10. bmcmededuc.biomedcentral.com bmcmededuc.biomedcentral.com/articles/10.1186/s12909-024-05669-8

Interprofessional education in cancer care – a scoping review A scoping review was conducted to identify the current status of IPE in cancer care and to summarise the results of previous research.