A Primary Palliative Care Intervention for Patients With Advanced Cancer

Study investigators will conduct a cluster randomized controlled trial comparing the CONNECT
intervention to usual care in 16 oncology clinics. CONNECT (Care Management by Oncology
Nurses to address supportive care needs) is a care management intervention using existing
oncology nurses to improve provision of primary palliative care within outpatient oncology
practices.

The study will enroll 672 patients with advanced cancer and their caregivers. The study will
assess the intervention's impact on patient and caregiver quality-of-life and psychological
outcomes at three months and on healthcare utilization through one year of follow up.
Investigators will follow a rigorous plan to establish and maintain intervention fidelity.
Detailed process information will be collected at all sites and the study will evaluate how
CONNECT impacts mortality and costs.

Following best practices for complex system-level interventions, the study will use a cluster
randomized trial design. The unit of randomization is the oncology practice, defined as a
unique location and provider group for outpatient oncology care. The unit of analysis is the
individual patient and caregiver.

Designated staff at each clinic will review oncologists' schedules on a weekly basis to
identify and track potentially eligible patients with an upcoming appointment. Research staff
will review tracking systems weekly to maintain recruitment fidelity. Identified patients
will receive a 1-page study information sheet at their next clinic visit, followed by a
detailed in-person explanation of the study from a trained staff member. This staff member
will obtain informed consent from all participants. To minimize potential selection bias,
participants will be told in advance of both groups and not randomized if they decline to be
exposed to one of them.

To enhance retention, blinded research assistants will conduct monthly follow-up calls to
assess healthcare utilization for participants in both groups. The data collection strategy
is designed to minimize participant burden by using parsimonious measures previously
pilot-tested with this population.

Participants will be (1) patients with advanced cancer receiving care at a participating
clinic; (2) their caregivers; (3) their oncology staff nurses, oncologists, and practice
managers.

Patient eligibility criteria. Inclusion criteria: (1) adults (≥ 21 years old); (2) the
oncologist "would not be surprised if the patient died in the next year"; (3) Eastern
Cooperative Oncology Group performance status (ECOG PS) of ≤ 2; (4) planning to receive
ongoing care from a participating oncologist and willing to be seen at least monthly.

Exclusion criteria: (1) Unable to read and respond to questions in English; (2) cognitive
impairment or inability to consent to treatment, as determined by the patient's oncologist;
(3) unable to complete baseline interview; (4) ECOG PS of 3 (capable of limited self-care;
confined to bed or chair > 50% of waking hours) or 4 (cannot carry on any self-care;
totally confined to bed or chair); (5) hematologic malignancy.

Caregiver eligibility criteria. Inclusion criteria: (1) adults (≥ 21 years old); (2) family
member or friend of an eligible patient. Exclusion criteria: (1) unable to read and respond
to questions in English; (2) unable to complete the baseline interview. Patients will be
asked to select as caregiver the person who is most likely to accompany them to visits or
help with their care should they need it.

Clinician eligibility criteria. Oncology staff nurses who undergo training to deploy
CONNECT, oncologists, and practice managers at participating sites will be eligible to
participate.