Cancer Clinical Trial - Comparative Trial of Home-Based Palliative Care

Status Terminated

Clinical Trial Summary

Background: To effectively alleviate suffering and improve quality of life for patients with serious illness and their caregivers, palliative care (PC) services must be offered across multiple settings. Research is needed to determine how best to optimize home-based palliative care (HBPC) services to meet the needs of individuals with high symptom burden and functional limitations.

Aim: The investigators will compare a standard HBPC model that includes routine home visits by a nurse and provider with a more efficient tech-supported HBPC model that promotes timely inter-professional team coordination via synchronous video consultation with the provider while the nurse is in the patient's home. The investigators hypothesize that tech-supported HBPC will be as effective as standard HBPC.

Design: Cluster randomized trial. Registered nurses (n~130) will be randomly assigned to the tech-supported or standard HBPC model so that half of the patient-caregiver dyads will receive one of the two models.

Setting/Participants: Kaiser Permanente (15 Southern California and Oregon sites). Patients (n=10,000) with any serious illness and a prognosis of 1-2 years and their caregivers (n=4,800)

Methods: Patients and caregivers will receive standard PC services: comprehensive needs assessment and care planning, pain and symptom management, education/skills training, medication management, emotional/spiritual support; care coordination, referral to other services, and 24/7 phone assistance.

Results: Primary patient outcomes: symptom improvement at 1 month and days spent at home in the last six months of life; caregiver outcome: perception of preparedness for caregiving.

Conclusion: Should the more efficient tech-supported HBPC model achieves comparable improvements in outcomes that matter most to patients and caregivers, this would have a lasting impact on PC practice and policy.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03694431
Study type	Interventional
Source	Kaiser Permanente
Contact
Status	Terminated
Phase	N/A
Start date	January 7, 2019
Completion date	January 24, 2020

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05346796` - Survivorship Plan HEalth REcord (SPHERE) Implementation Trial	N/A
Recruiting	`NCT05094804` - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents	Phase 1/Phase 2
Completed	`NCT04867850` - Effect of Behavioral Nudges on Serious Illness Conversation Documentation	N/A
Enrolling by invitation	`NCT04086251` - Remote Electronic Patient Monitoring in Oncology Patients	N/A
Completed	`NCT01285037` - A Study of LY2801653 in Advanced Cancer	Phase 1
Completed	`NCT00680992` - Study of Denosumab in Subjects With Giant Cell Tumor of Bone	Phase 2
Completed	`NCT00062842` - Study of Irinotecan on a Weekly Schedule in Children	Phase 1
Active, not recruiting	`NCT04548063` - Consent Forms in Cancer Research: Examining the Effect of Length on Readability	N/A
Completed	`NCT04337203` - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship	N/A
Recruiting	`NCT04349293` - Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways	N/A
Terminated	`NCT02866851` - Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy	N/A
Active, not recruiting	`NCT05304988` - Development and Validation of the EFT for Adolescents With Cancer
Completed	`NCT04448041` - CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
Completed	`NCT00340522` - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
Recruiting	`NCT04843891` - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.	Phase 1
Active, not recruiting	`NCT03844048` - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial	Phase 3
Completed	`NCT03167372` - Pilot Comparison of N-of-1 Trials of Light Therapy	N/A
Completed	`NCT03109041` - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source	Phase 1
Terminated	`NCT01441115` - ECI301 and Radiation for Advanced or Metastatic Cancer	Phase 1
Recruiting	`NCT06206785` - Resting Energy Expenditure in Palliative Cancer Patients

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Comparative Trial of Home-Based Palliative Care — HomePal

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms