Clinical trial NCT02712229: A Primary Palliative Care Intervention for Patients With Advanced Cancer
Official title: A Cluster Randomized Trial of a Primary Palliative Care Intervention (CONNECT) for Patients With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Cancer
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-03-18
Enrollment: 1290
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The overall goal of this study is to test whether a nurse-led intervention to improve provision of primary palliative care within oncology practices (CONNECT) can decrease morbidity for patients with advanced cancer and their caregivers.

The specific aims are to:

Aim 1. Assess the effects of CONNECT on patient quality of life (primary outcome), symptom burden, and mood at 3-month follow-up.

Aim 2. Assess the effects of CONNECT on caregiver burden and mood at 3-month follow-up.

Aim 3. Assess the effects of CONNECT on healthcare resource use over 1 year of follow-up.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of Life - patient
timeFrame: Change from baseline to 3 months
Secondary outcomes:
measure: Symptom burden - patient
timeFrame: Change from baseline to 3 months
measure: Depression and anxiety symptoms - patient
timeFrame: Change from baseline to 3 months
measure: Depression and anxiety symptoms - caregiver
timeFrame: Change from baseline to 3 months
measure: Caregiver burden - caregiver
timeFrame: Change from baseline to 3 months
measure: Healthcare Utilization
timeFrame: 1 year
measure: Survival - patients
timeFrame: 1 year
Other outcomes:
measure: Patient-Oncologist Therapeutic Relationship
timeFrame: Change from baseline to 3 months
measure: Hope - patients and caregivers
timeFrame: Change from baseline to 3 months
measure: Self-efficacy - patients and caregivers
timeFrame: 3 months
measure: Satisfaction - caregivers
timeFrame: Change from baseline to 3 months
measure: Distress - patients
timeFrame: Change from baseline to 3 months
measure: Illness understanding, care preferences, advance care planning - patients
timeFrame: Change from baseline to 3 months
measure: Burnout - clinicians
timeFrame: Baseline and annually up to 60 months
measure: Satisfaction with CONNECT and recommendations for improvement
timeFrame: Annually up to 60 months
Locations:
city: Pittsburgh
country: United States
facility: UPMC Cancer Centers
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Yael Schenker, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References:
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