By Ruth C. Carlos, MD, MS

Cancer care delivery research (CCDR) aims to improve clinical outcomes and patient well-being by focusing on the complex interactions between the patient, provider, and system factors that influence care delivery.

At the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN), the Cancer Care Delivery Research Committee is the hub for research in this domain, where the focus is on the delivery of effective, evidence-based interventions into clinical practice. Among the major themes that underlie our CCDR effort are care coordination and teams-based care, financial burden of cancer, and addressing barriers to care for special populations.

The studies by ECOG-ACRIN investigators highlighted below align with the National Cancer Institute's (NCI) mission for the CCDR program: to generate evidence that can be used to improve clinical practice, particularly through the evaluation of pragmatic interventions in heterogeneous community practices.

EAQ221CD/CONCURxP: Improving Medication Adherence in Breast Cancer
Study Chair: Gelareh Sadigh, MD
Study Co-Chair: Ilana Graetz, PhD
Status: Currently accruing

CDK4/6 inhibitors, such as palbociclib, ribociclib, or abemaciclib, are used to treat patients with hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer—the most common subtype. Because these treatments are so effective, it is critical to provide interventions that support patients in their efforts to adhere to the medication. Common reasons for non-adherence include forgetfulness and treatment-related side effects. CDK4/6 inhibitors also have complex dosing schedules and can be more difficult to manage than other oral treatments.

The EAQ221CD/CONCURxP study aims to address these barriers using a mobile health intervention. The study is enrolling 390 patients with breast cancer of any stage who are taking a CDK4/6 inhibitor. All participants are asked to keep their CDK4/6 inhibitor medication in an electronically monitored Wisebag^TM pouch. This portable device automatically tracks medication use when the device is opened and marks the dose as ‘taken’ in real time directly from the device to an online server.

Participants are randomized 1:1 to receive either the control arm (usual care with use of Wisebag for adherence monitoring) or the experimental arm (use of Wisebag for adherence monitoring plus CONCURxP, the Connected Customized Treatment Platform). This intervention includes personalized and interactive text message reminders and alerts; notifications to the provider team to call patients when adherence is inconsistent; information about financial support resources; and access to a study website where patients and providers can track adherence.

The trial’s primary objective is to compare CDK4/6 inhibitor adherence between the two groups at 12 months after randomization. EAQ221CD opened in October 2023 and has accrued over 320 participants.

EAQ222CD/CostCOM: To Reduce Financial Hardship for Patients with Cancer
Study Chair: Gelareh Sadigh, MD
Study Co-Chair: Pamala A. Pawloski, PharmD
Status: Currently accruing

Many people with cancer experience financial hardship, leading them to delay, forgo, change, or even stop cancer care. The EAQ222CD study is developing and testing a scalable intervention (CostCOM) to reduce financial hardship using a three-pronged strategy: (1) estimated out-of-pocket costs for treatment; (2) navigation to financial assistance programs and discussion of approaches to improve insurance coverage; and (3) counseling to address financial concerns.

The study plans to enroll approximately 720 patients. To be eligible for CostCOM, patients must be receiving care at a participating site in the NCI Community Oncology Research Program (NCORP). They must be aged 18 or older, fluent in written and spoken English or Spanish, and within 120 days of a new diagnosis of any type of solid cancer (any stage). Patients must have initiated systemic therapy or plan to initiate systemic therapy within 30 days of consenting to the trial.

Participants are randomized to receive either CostCOM or enhanced usual care (EUC). Patients in the CostCOM arm participate in four 1-hour phone/video one-on-one sessions with a remote financial counselor at baseline, 3, 6, and 12 months. Patients in the EUC arm receive the usual financial information offered at the cancer clinic, as well as a brochure from the Patient Advocate Foundation, a national non-profit organization that offers free financial counseling.

The trial’s primary objective is to compare patient-reported cost-related cancer care non-adherence between the two study groups after 12 months. EAQ222CD opened in February 2024 and has accrued over 650 patients.

EAQ241CD/LIFT UP: Addressing Financial Hardship in AYA Cancer Survivors
Study Chair: John Salsman, PhD
Study Co-Chair: Sarah Birken, PhD, MSPH
Status: Coming soon

Adolescents and young adults (AYAs) with cancer experience significant and extended disruption in their lives and are at greater risk of financial hardship than healthy peers. The economic and human costs of cancer in AYAs are considerable: they may be uninsured or have inadequate insurance, limited financial assets, and experience significant work interruption, leading to greater financial strain during and after treatment. In addition, most AYAs are treated in community-based settings, which may have fewer tailored financial support resources than academic medical centers.

The EAQ241CD study plans to test two evidence-based interventions combined as a single, comprehensive case management system—LIFT UP. The first part is an education component known as CHAT (Let's CHAT About Health Insurance). The second, LIFT (Lessening the Impact of Financial Toxicity), addresses organization-level determinants of financial hardship by coordinating access to financial assistance programs; assessing eligibility for financial support resources; clarifying treatment cost expectations; and helping patients develop a plan to cope with costs of care.

The real-world efficacy of LIFT UP will be studied among NCORP sites, with a planned accrual of 408 participants. Participants may have any type of cancer other than non-melanoma skin cancer and must be within 5 years of completion of curative intent therapy. They will be randomized 1:1 to the LIFT UP intervention (delivered via videoconference by a trained financial navigator) or usual care (the financial screening/navigation services typically provided at the participating NCORP site). Participants in both arms will be asked to complete written assessments at regular intervals. In addition, 18 AYA participants from the LIFT UP arm will be asked to complete qualitative interviews; interviews with 40 participating site staff are also planned.

Researchers hope results will help to identify when LIFT UP should be delivered, which AYAs should receive the intervention, and what strategies are needed for successful implementation. Results will guide a future implementation trial to address financial hardship for at-risk AYAs. This study is currently expected to open in late spring or early summer 2026.

EAQ171CD/The Smoke Free Support Study 2.0
Study Chair: Elyse Park, PhD, MPH
Study Co-Chair: Jamie S. Ostroff, PhD
Status: Results presented

It is widely known that smoking can cause cancer and that continuing to use tobacco after a cancer diagnosis can lead to worse outcomes. Yet, patients may have difficulty finding support to quit smoking in their local community.

EAQ171CD tested an online tobacco treatment program, in combination with nicotine replacement therapy (NRT). This combination, called Virtual Sustained Treatment (VST), included up to 11 sessions of counseling over a 6-month period, and the option of receiving up to 12 weeks of free NRT patches or lozenges. A total of 306 patients receiving treatment for different types of cancer at community-based practices were randomly assigned to VST or to enhanced usual care (i.e., referral to the NCI’s Smoking Quitline, which offers free counseling).

Patients who participated in the VST program were almost twice as likely to quit smoking than participants who received the enhanced usual care of a Smoking Quitline referral. The study demonstrates that a centralized telehealth-based smoking cessation treatment program can be successfully carried out in community oncology sites nationwide. Results were presented at two meetings of the American Society of Clinical Oncology (ASCO) in 2023 and 2024.

These studies and others in development demonstrate the value of integrating care delivery research within the NCORP network, where the majority of patients with cancer receive their treatment. Such research allows our investigators to collect primary data and initiate interventions; look across a mix of practice models and heterogeneous populations; and follow patients from time of diagnosis of their cancer through to treatment and survivorship.

Dr. Carlos (Columbia University) is chair of ECOG-ACRIN’s Cancer Care Delivery Research Committee.