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A Primary Palliative Care Intervention for Patients With Advanced Cancer

NCT02712229 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1290

Last updated 2021-04-08

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

CONNECT

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 & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Yael Schenker, MD, MAS · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-27
Primary Completion
2020-01-27
Completion
2020-10-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02712229 on ClinicalTrials.gov