CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,290 enrolled
Drug / intervention
CONNECTbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02712229
NCT02712229N/ACompleted

A Cluster Randomized Trial of a Primary Palliative Care Intervention (CONNECT) for Patients With Advanced Cancer

University of Pittsburgh·interventional·Posted Mar 18, 2016·Updated Apr 8, 2021

In Brief

A clinical study evaluating CONNECT for Advanced Cancer. Completed, enrolled 1,290 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Cancer
CountriesUnited States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 18, 2016
Enrollment StartJul 27, 2016
Primary CompletionJan 27, 2020
Study CompletionOct 15, 2020
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 10.3 years ago

Interventions

CONNECTbehavioral

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.