Advanced Cancer
Conditions
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.
Interventions
BEHAVIORALCONNECT
Primary palliative care, care management intervention led by existing oncology nurses. Deployed through a series of nurse-led encounters before or after regularly scheduled oncology visits. Based on best practices in palliative oncology care, the first visit focuses on establishing rapport, addressing symptom needs and choosing a surrogate decision maker. Subsequent visits include additional focus on treatment preferences and future goals. Visits are guided by patient-reported outcomes. During all encounters, the nurse works with patients/caregivers to complete/update individualized Shared Care Plans. After all visits, the nurse discusses patients' symptoms, preferences and goals with their oncologists via a mandatory check-in session and a follow-up call with the patient and/or caregiver.
Sponsors
National Cancer Institute (NCI)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life - patient | Change from baseline to 3 months | The investigators will compare change in the 3-month FACIT-Pal scores between enrolled patients at intervention clinics and enrolled patients at usual care clinics. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression and anxiety symptoms - patient | Change from baseline to 3 months | The investigators will compare change in the 3-month Hospital Anxiety and Depression Scale (HADS) scores between enrolled patients at intervention clinics and enrolled patients at usual care clinics. |
| Depression and anxiety symptoms - caregiver | Change from baseline to 3 months | The investigators will compare change in the 3-month Hospital Anxiety and Depression Scale (HADS) scores between enrolled caregivers at intervention clinics and enrolled caregivers at usual care clinics. |
| Symptom burden - patient | Change from baseline to 3 months | The investigators will compare change in the 3-month Edmonton Symptom Assessment Scale (ESAS) scores between enrolled patients at intervention clinics and enrolled patients at usual care clinics. |
| Healthcare Utilization | 1 year | To inform future dissemination efforts and aid in understanding optimal financing models, the investigators will calculate implementation costs of the intervention and determine the effects of CONNECT on healthcare utilization, including hospitalizations, chemotherapy use, and hospice use. |
| Survival - patients | 1 year | The investigators will calculate survival time from date of enrollment using the Kaplan-Meier method. We will use frailty models to assess for any effect of CONNECT on survival, controlling for the effects of clustering. |
| Caregiver burden - caregiver | Change from baseline to 3 months | The investigators will compare change in the 3-month Zarit Burden Interview-Short scores between enrolled caregivers at intervention clinics and enrolled caregivers at usual care clinics. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient-Oncologist Therapeutic Relationship | Change from baseline to 3 months | The investigators will compare change in the 3-month Human Connection Scale scores between enrolled patients at intervention clinics and enrolled patients at usual care clinics. |
| Satisfaction with CONNECT and recommendations for improvement | Annually up to 60 months | The investigators will assess satisfaction with CONNECT and recommendations for improvement among clinicians at intervention clinics annually. |
| Hope - patients and caregivers | Change from baseline to 3 months | The investigators will compare change in the 3-month Herth Hope Index scores between enrolled patients and caregivers at intervention clinics and enrolled patients and caregivers at usual care clinics. |
| Self-efficacy - patients and caregivers | 3 months | The investigators will compare 3-month scores on the Cancer Behavior Inventory-Brief (patients) and the Caregiver Inventory (caregivers) between enrolled patients and caregivers at intervention clinics and enrolled patients and caregivers at usual care clinics. |
| Satisfaction - caregivers | Change from baseline to 3 months | The investigators will compare change in the 3-month FAMCARE-2 scores between enrolled caregivers at intervention clinics and enrolled caregivers at usual care clinics. |
| Distress - patients | Change from baseline to 3 months | The investigators will compare change in the 3 months scores on the Distress Thermometer between enrolled patients at intervention clinics and enrolled patients at usual care clinics. |
| Illness understanding, care preferences, advance care planning - patients | Change from baseline to 3 months | The investigators will compare change in patient illness understanding, care preferences, and advance care planning between enrolled patients at intervention clinics and enrolled patients at usual care clinics. |
| Burnout - clinicians | Baseline and annually up to 60 months | The investigators will compare burnout (maslach burnout inventory) between clinicians at intervention clinics and usual care clinics. |
Countries
United States
Outcome results
None listed