Onco-primary Care Networking to Support TEAM-based Care
Onco-primary Care Networking to Support TEAM-based Care
The proposed ONE TEAM Study is an 18-month, cluster randomized controlled trial. This study
 will use a sequential multiple assignment randomized trial (SMART) design with a second
 randomization for the intervention group using a dynamic treatment regimen approach. The
 investigators propose to randomize 800 adults with newly-diagnosed selected cancers treated
 with curative intent (breast, prostate, colorectal, endometrial, non-small cell lung, and
 endometrial) and with >1 selected cardiovascular disease (CVD) comorbidity (hypertension,
 type 2 diabetes mellitus, hypercholesterolemia). Participants will be enrolled through Duke
 Cancer Institute and two community-based oncology practices, both settings serving
 socio-demographically diverse populations. The unit of randomization will be the PCP clinic;
 there will be ~80 PCP clinics across North Carolina involved in the study. The overarching
 goals of this study are to improve chronic disease management and communication among cancer
 survivors by engaging PCPs as active members of the cancer care team and reframing the
 message to cancer survivors and providers.
This is an 18-month cluster randomized controlled trial using a SMART design with two
 randomizations (the second using an embedded dynamic treatment regimen), with a target
 enrollment of 800 patients with one of six solid tumors (stage I-III breast, prostate,
 colorectal, endometrial, and head/neck cancer; stage I-II non-small cell lung cancer) who are
 being treated with curative intent. To engage the PCP early in the process, the investigators
 will enroll patients at the time of their first or second visit with a cancer specialist
 (e.g., surgeon, radiation or medical oncologist). The investigators estimate that 80 unique
 community-based PCP clinics across North Carolina will be involved in the study. The
 investigators will determine the effectiveness of the multi-level intervention compared with
 usual care on (1) Healthcare Effectiveness Data and Information Set (HEDIS) quality measures
 of management of the three CVD comorbidities using laboratory testing (glycated hemoglobin
 [A1c], lipid profile) and blood pressure measurements; (2) medication adherence assessed
 pharmacy refill data using Proportion of Days Covered (PDC); and (3) patient-provider
 communication (Patient-Centered Communication in Cancer Care, PCC-Ca-36).

 Key aspects of the intervention are to: reframe the message to patients, PCPs, oncologists,
 and the respective health care teams in these two settings to emphasize the importance of
 optimizing the management of comorbidities during and after cancer therapy; promote a change
 in the workflow in both PCP and oncology practices; enhance PCP-oncologist relationships, and
 utilize EHR technology. There are two phases of the intervention, both having patient- and
 PCP-level components. During the first phase of the intervention, occurring with the first
 randomization, the investigators will test the effectiveness of a self-guided, informational
 strategy (iGuide). For PCP clinics that do not achieve the HEDIS targets, a booster phase
 with tailored (patient-level) and targeted (PCP-level) strategies will be tested with a
 second randomization (iGuide2).

 The intervention has been designed to utilize the electronic health record (EHR). At the
 cancer centers, the research team will use the Epic patient portal, MyChart. For PCPs who do
 not use Epic, the research team will use an Epic tool, MedLink, which allows them to view a
 patient's medical records in our system including visit summaries, progress notes and
 results. They can use the Epic inbasket and receive/send messages related to their patient's
 care at the Duke Cancer Institute (DCI), receive alerts, make referrals, and track the
 progress of requests. The PCPs participation is voluntary and their completion of study
 activities will serve as their implied consent to participate.

 All participants in the study will be given a survivorship care plan based on the American
 Society of Clinical Oncology (ASCO) template. Because the investigators will be recruiting
 participants at our cancer centers and community practices, there will be an inevitable
 contamination across cancer specialists. Thus, the investigators did not include an
 oncology-level intervention. However, cancer specialists are integral to the patient- and
 PCP-level interventions. At the end of the study, patients and PCPs will be mailed a
 newsletter with a summary of the study findings. Lastly, it is inevitable that some patients
 will change their PCP during the study. When notified of the change, the research team will
 send the new PCP the intervention materials.
Inclusion Criteria:

 A total of 800 individuals who fall under the following criteria will be enrolled:

 -  Diagnosed with any of the following selected solid tumors -

 -  Stage I-III breast [female], colorectal, endometrial, head/neck [H/N], and
 prostate cancer

 -  Stage I-II non-small cell lung cancer [NSCLC]

 -  Treated with curative intent

 -  18-79 years old

 -  Has at least one of three CVD comorbidities (hypertension, diabetes, or
 hypercholesterolemia) - based upon whether the patient is currently on a medication
 for the comorbidity at time of recruitment

 -  Had a visit with their PCP in the previous 12 months

 Exclusion Criteria:

 Individuals with a history of the following conditions will be ineligible:

 -  Myocardial infarction in the previous 24 months

 -  Stage III-IV heart failure

 -  Stage III-IV chronic kidney disease