Ignite Creation Date:
2024-05-06 @ 2:11 PM
Last Modification Date:
2024-10-26 @ 1:27 PM
Study NCT ID:
NCT04248244
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2020-01-23
Brief Title:
Effects of Early Palliative Care Integration on Patients With Newly Diagnosed Multiple Myeloma
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
A Pilot Study to Determine the Effects of Early Palliative Care Integration on Patients With Newly Diagnosed Multiple Myeloma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Multiple Myeloma MM is a common type of cancer involving the cells in the blood commonly affecting bones kidneys and blood Although it remains incurable MM has become a highly treatable form cancer thanks to new and improved treatment modalities As patients deal with this disease they often suffer from multiple symptoms that are caused by both the disease itself and the different drugs used to treat it Research has shown that the most common symptoms patients suffer from include pain constipation tiredness tingling in hands and feet breathlessness sadness and difficulty remembering things These symptoms may negatively affect the quality of life of patients
Palliative care PC is a type of treatment aimed at relieving symptoms and promoting the most optimal quality of life QOL for patients and their caregivers Research has shown that patients with certain types of cancers such as colon cancer and lung cancer do better if they are seen by a PC provider early in the course of their disease This study seeks to determine the effects of early PC involvement on participants with newly diagnosed MM
Palliative care PC is a type of treatment aimed at relieving symptoms and promoting the most optimal quality of life QOL for patients and their caregivers Research has shown that patients with certain types of cancers such as colon cancer and lung cancer do better if they are seen by a PC provider early in the course of their disease This study seeks to determine the effects of early PC involvement on participants with newly diagnosed MM
Detailed Description:
This is a pilot study with a prospective cohort design and based in the outpatient or ambulatory care setting Each participant will be followed for 12 months
Twenty eligible patients will be enrolled and within eight weeks of diagnosis Patients will meet with a member of the outpatient PC team which consists of board-certified PC physicians advance practice providers and nurse care coordinators within three weeks of enrollment Additional visits may be scheduled at the discretion of participants oncologists or PC providers and participants will receive routine oncologic care throughout the study period
The primary objective of this study is to obtain preliminary data on the effects of early PC involvement in a cohort of patients with newly diagnosed symptomatic MM
The secondary objectives of this study are to assess self-reported QOL estimate the change in QOL relative to baseline estimate number of participants with self-reported symptoms of depression and anxiety to determine if monthly PC visits are feasible for participants and to estimate health services utilization
Twenty eligible patients will be enrolled and within eight weeks of diagnosis Patients will meet with a member of the outpatient PC team which consists of board-certified PC physicians advance practice providers and nurse care coordinators within three weeks of enrollment Additional visits may be scheduled at the discretion of participants oncologists or PC providers and participants will receive routine oncologic care throughout the study period
The primary objective of this study is to obtain preliminary data on the effects of early PC involvement in a cohort of patients with newly diagnosed symptomatic MM
The secondary objectives of this study are to assess self-reported QOL estimate the change in QOL relative to baseline estimate number of participants with self-reported symptoms of depression and anxiety to determine if monthly PC visits are feasible for participants and to estimate health services utilization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None