Advanced Cancer Clinical Trial
Official title:
Improving Patient Outcomes in End-of-Life Care Provided by Physicians and Nurses
This research study is a randomized trial to evaluate a training program that is designed to improve the communication skills of clinicians. The training program focuses on care for patients with serious illnesses and their family members, and assesses effectiveness using patient and family outcomes. The long term goal of this research is to improve communication skills of doctors and nurses, thereby improving patient and family outcomes.
Three decades of research on end-of-life care in the United States indicates that people who
are dying often spend their final days with a significant burden of pain and other symptoms
and receive care they would not choose. Patient-clinician communication about end-of-life
care is an important focus for improving patient-centered end-of-life care for three
reasons: 1) it is an integral component of clinician skill that affects all other aspects of
end-of-life care; 2) physicians and nurses in practice do not demonstrate adequate skills
for communicating about end-of-life care; and 3) current training in end-of-life
communication is inadequate. Studies have shown that clinicians can improve their
communication skills with experiential training, but no studies to date have shown that an
intervention to improve clinician communication skill improves patient outcomes.
Furthermore, despite widespread knowledge that end-of-life care is best delivered in an
interdisciplinary context, most studies do not incorporate interdisciplinary training that
includes physicians and nurses.
This is a randomized trial of a communication skills workshop for internal medicine
residents and nurse practitioner (NP) students. A total of 373 residents and 128 NP students
from two large training programs (UW and MUSC) will be randomized to either the intervention
or usual education. The study's primary outcome measure will be the QOC scores on the
"communication about end-of-life care" domain. The QOC will be assessed by patients, family
members, and nurses before and after the intervention time period for all trainees.
Secondary outcome measures are patient symptoms and patient-, family - and nurse-assessed
QEOLC scores. Outcome measures will be collected for 5 patients and family members per
trainee before the intervention period and 5 patients and family members per trainee after
the intervention period. Process measures for both residents and NP students will include
pre- and post-intervention assessment of knowledge, attitudes, and behavior regarding
communication using standardized patient assessment as well as self-assessment and faculty
assessment.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03181854 -
Randomized Controlled Trial of Integrated Early Palliative Care
|
N/A | |
Completed |
NCT01197170 -
Hormone Receptor Positive Disease Across Solid Tumor Types: A Phase I Study of Single-Agent Hormone Blockade and Combination Approaches With Targeted Agents to Provide Synergy and Overcome Resistance
|
Phase 1 | |
Recruiting |
NCT05045040 -
Empathetic Communication Facilitation Program for Early Initiation of End-of-life Discussions
|
N/A | |
Active, not recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03994601 -
An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03667716 -
COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
|
Phase 1 | |
Completed |
NCT01393990 -
A Study of LY2228820 in Participants With Advanced Cancer
|
Phase 1 | |
Completed |
NCT02857270 -
A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer
|
Phase 1 | |
Recruiting |
NCT03175224 -
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
|
Phase 2 | |
Active, not recruiting |
NCT04121676 -
Anti-CD137 and Anti-CTLA-4 Monoclonal Antibody in Patients With Advanced Cancer
|
Phase 1 | |
Active, not recruiting |
NCT03177291 -
Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC
|
Phase 1 | |
Completed |
NCT03980041 -
Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)
|
Phase 2 | |
Active, not recruiting |
NCT03674567 -
Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination With Pembrolizumab
|
Phase 1/Phase 2 | |
Recruiting |
NCT04823377 -
Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer.
|
N/A | |
Completed |
NCT02778126 -
A Study of Prexasertib (LY2606368) in Participants With Advanced Cancer
|
Phase 1 | |
Completed |
NCT02529553 -
A Study of LY3076226 in Participants With Advanced or Metastatic Cancer
|
Phase 1 | |
Completed |
NCT02507544 -
A Safety and Pharmacokinetic Study of TRX-818 Administered Orally to Patients With Advanced Cancer
|
Phase 1 | |
Completed |
NCT02245204 -
Phase I Studies of Chlorogenic Acid for Injection for Tolerance and Pharmacokinetic of Advanced Cancers
|
Phase 1 | |
Completed |
NCT01583777 -
Phase I Mass Balance, PK and Safety Study of 14C-Labeled Belinostat in Patients With Advanced Cancer
|
Phase 1 | |
Terminated |
NCT01929941 -
An Open-Label Study of a Novel JAK-inhibitor, INCB047986, Given in Patients With Advanced Malignancies
|
Phase 1 |