Neoplasm Clinical Trial
Official title:
Effectiveness of the FairCare System for Patients With Advanced Illness
This study of the FairCare Program (FC) is designed to address end of life (EOL) care delivery issues by reducing barriers to effective EOL care among health care providers, family members, surrogates, and Chronic Heart Failure (CHF) patients using a comprehensive, multi-pronged approach delivered by a care coordinator and supported by an interdisciplinary team.
Background:
This study of the FairCare Program (FC) is designed to address end of life (EOL) care
delivery issues by reducing barriers to effective EOL care among health care providers,
family members, surrogates, and Chronic Heart Failure (CHF) patients using a comprehensive,
multi-pronged approach delivered by a care coordinator and supported by an interdisciplinary
team.
Objectives:
Evaluate the impact of FC on: 1) improving the quality of life (QOL) and health care
delivery for CHF patients with advanced illness, (i.e. ejection fractions of 35% or less, or
assessed as level III or IV on the NYS Heart Association Classification System); 2)
addressing their fears about dying; 3) increasing their use of Advance Directives (ADs); and
4) improving provider compliance with ADs. Also, describe trends that may occur in
disease-specific QOL, survival, and health care use and cost.
Methods:
The study employs a randomized control group design. There are two treatment arms, the FC
treatment condition, and the usual care (UC) control condition. Assessments for improving
quality of life (QOL), and quality of care delivery are taken at baseline, and at three and
six months. Assessments of AD use, i.e. frequency of formulation and documentation of ADs,
are taken at baseline, three and six months at one year and 18 months. Because data about
compliance with ADs and utilization and cost may not be fully comprehensive until patients'
deaths, to maximize the sample size for these variables, and hence the power of the study to
detect difference in these outcomes, data on compliance with ADs will be collected in the
final year of the study, and data on utilization and cost will be aggregated in monthly
intervals and collected from baseline to 18 months. One year of VA pre-intervention health
care utilization and cost data will also be collected to assess baseline utilization and to
control for any pre-existing differences in the propensity of patients to use health care
services. Also, an intention to treat methodology will be used during data analyses.
Status:
The study ends 9-30-04, data for VA cost, Medicare cost, consistency of medical care with
patient preferences, and survival, are being collected and analyzed for the final report.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT01441115 -
ECI301 and Radiation for Advanced or Metastatic Cancer
|
Phase 1 | |
| Completed |
NCT00199836 -
A Pilot Study of NY-ESO-1b Peptide Plus CpG 7909 and Montanide® ISA-51 in Patients With Cancer.
|
Phase 1 | |
| Completed |
NCT01672944 -
Evaluating Biobanking Educational Tools
|
N/A | |
| Not yet recruiting |
NCT02226289 -
Bevacizumab-containing Regimen for Metastatic Colorectal Cancer Failed to Cytotoxic Treatment
|
Phase 2 | |
| Completed |
NCT02759640 -
A Phase I Trial of HS-10241 in Solid Tumors
|
Phase 1 | |
| Completed |
NCT02747342 -
A Phase 1 Trial of SHR3680 With or Without SHR3162 in Prostate Cancer
|
Phase 1 | |
| Completed |
NCT02746185 -
Cancer Associated Thrombosis, a Pilot Treatment Study Using Rivaroxaban
|
Phase 3 | |
| Completed |
NCT02536586 -
A Study of LY3023414 in Japanese Participants With Advanced Cancer
|
Phase 1 | |
| Completed |
NCT02309164 -
The Use of Acupuncture for Treatment of Chemotherapy-induced Peripheral Neuropathy (CIPN).
|
N/A | |
| Completed |
NCT02394821 -
Odor Management in Fungating Wounds Comparing Metronidazole and Polihexanide
|
Phase 3 | |
| Completed |
NCT01457196 -
Development of a Tumor Molecular Analyses Program and Its Use to Support Treatment Decisions
|
N/A | |
| Completed |
NCT00143533 -
Prevention of Diarrhea in Patients Taking IV Irinotecan for Relapsed or Difficult to Treat Pediatric Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT05450562 -
Dose Escalation and Expansion Study of SAR444200-based Regimen in Adult Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT00001835 -
Oxaliplatin in Cancer Patients With Impaired Kidney Function
|
Phase 1 | |
| Completed |
NCT00001341 -
A Phase I Trial of ZD1694 (TOMUDEX), an Inhibitor of Thymidylate Synthase, in Pediatric Patients With Advanced Neoplastic Disease
|
Phase 1 | |
| Completed |
NCT01425008 -
Study of MLN2480 in Participants With Relapsed or Refractory Solid Tumors Followed by a Dose Expansion in Participants With Metastatic Melanoma
|
Phase 1 | |
| Recruiting |
NCT05101798 -
The Role of 5-Aminolevulinic Acid Fluorescence-Guided Surgery in Head and Neck Cancers: a Pilot Trial
|
Phase 2 | |
| Completed |
NCT01920061 -
A Study Of PF-05212384 In Combination With Other Anti-Tumor Agents and in Combination With Cisplatin in Patients With Triple Negative Breast Cancer in an Expansion Arm (TNBC)
|
Phase 1 | |
| Terminated |
NCT03251924 -
A Dose Escalation and Combination Immunotherapy Study to Evaluate BMS-986226 Alone or in Combination With Nivolumab or Ipilimumab in Patients With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT02851706 -
Natural History of and Specimen Banking for People With Tumors of the Central Nervous System
|