Brown University School of Public Health

Outcomes and Economics Assessment Unit



ECOG-ACRIN

EA2185

Effective surveillance requires accurate imaging and endoscopic risk stratification tools, and optimized intervals for pancreatic cyst visualization to facilitate effective intervention. These factors must be balanced against the acceptability and risk to the patient associated with imaging, endoscopy and surgery. This randomized trial will compare the risks, benefits and costs of more (Fukuoka) and less (AGA) aggressive surveillance strategies. Such a prospective comparison also anticipates the growing role of biomarkers in pancreatic cyst risk stratification. Optimal understanding of the predictive and prognostic utility of biomarkers requires prospective sample collection linked to longitudinal clinical outcomes in patients who undergo surgery, but also those who do not.

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ECOG-ACRIN

EAQ162CD

The impact of a cancer diagnosis on employment and financial burden is poorly understood but is increasingly important to patients and families as the cost of cancer diagnostics and therapeutics increase. Understanding the longitudinal impacts of a cancer diagnosis and treatment on patient’s financial distress, employment, and quality of life will be essential in developing interventions to address the financial consequences of a cancer diagnosis. This is a single-armed longitudinal study of financial burden in patients with colon, rectal, or rectosigmoid junction cancer. Measurements of financial burden (COST score) will be collected at 5 time points over a 24-month follow-up period. Surveys will be completed both by sites, to identify available clinical resources, and by participants, to assess the QOL and cost effects. The primary endpoint of this study is the change of COST score from baseline to the 12-month follow-up (FU) measurements.

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ECOG-ACRIN

EAQ171CD

Smokefree support 2 (EAQ171) will examine the effectiveness and implementation of a virtually delivered, evidence-based tobacco treatment into cancer care for patients in community oncology settings. The study is designed to compare the effectiveness and implementation of an Enhanced Usual Care (EUC; control group) versus a Virtual Intervention Treatment (VIT; intervention group) for tobacco cessation in newly diagnosed cancer patients who smoke. Trial findings will establish the effectiveness and cost of utilizing a virtual strategy to deliver evidence-based tobacco treatment in community oncology settings and provide detailed initial data on implementation processes that will inform subsequent testing of multi-level implementation strategies for broad national dissemination into community cancer care settings.

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ECOG-ACRIN

EAQ191

The CARISMA Study (EAQ191) is a pilot study to determine the feasibility of whether home monitoring Systolic Blood Pressure (SBP) with intensive SBP control (target <120 mmHg) can be effectively implemented in patients with metastatic renal cell or thyroid cancers receiving anti-angiogenic tyrosine kinase inhibitors (AA-TKIs) before planning a phase III randomized clinical trial (RCT) to test the hypothesis that such intervention improves cardiovascular (CV) and oncologic outcomes compared with standard blood pressure management (target < 140mmHg).

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ECOG-ACRIN

EAQ202

This is a pilot randomized controlled trial with adolescents and young adults (AYAs) is to evaluate the feasibility and acceptability of completing PROs informed by their priorities. AYAs will be consented, randomized, and asked to reorder a dashboard of 15 HRQOL domains by priority at each assessment period. AYAs will complete baseline, 1-, 3-, 6-, and 12-month assessments which will include a combination of CATs and static short forms based. Subject will be randomized to complete either a fixed set of instruments measuring: physical function, pain, cognitive function, social support, and finances (Fixed PRO) or their top 5 HRQOL instruments (Choice PRO)

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ECOG-ACRIN

EAQ211

The purpose of this study is to understand more about how the world young people live in affects the outcomes of their cancer treatment. We call this field of research social genomics, and it takes a close look at why and how different social factors like social stress, conflict and isolation can impact cancer diagnoses and outcomes. see more at https://aftercancergenomics.org/

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ECOG-ACRIN

EAQ221CD

This clinical trial compares the use of the connected customized treatment platform (CONCURxP) to enhanced usual care (EUC). Subjects will use a study assigned Wisebag to help monitor medication adherence in patients with metastatic breast cancer who are taking a CKD4/6 inhibitor.

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ECOG-ACRIN

EAQ222CD

This study is a randomized controlled trial of a customized financial support intervention (CostCOM) to assess effectiveness on cost-related cancer care nonadherence, material hardship, financial worry, and QOL compared to enhanced usual care (EUC) for newly diagnosed patients with solid tumor who plan to receive treatment within 30 days of study entry. Evaluations will be conducted to assess providers’ and patients’ satisfaction with CostCOM, and perceived barriers and facilitators to CostCOM delivery or receipt. The EUC consists of an introductory package containing a study overview and a brochure for Patient Advocate Foundation (PAF) that describes their financial navigation services and contact information. Subjects can self-refer themselves to the PAF at no cost. The CostCOM intervention consists of four 1-hour phone or video interactive one-on-one sessions with a remote financial navigator at TailorMed..

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