Ignite Creation Date:
2024-07-17 @ 11:02 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06485076
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-03-25
Brief Title:
Early Palliative Care for Patients With Multiple Myeloma and Aggressive Lymphoma
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Phase II Feasibility Study of Early Palliative Care for Patients With Multiple Myeloma and Aggressive Lymphoma
Status:
RECRUITING
Status Verified Date:
2024-08
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:
Patients with multiple myeloma experience a wide range of physical and psychological symptoms from the time of their diagnosis Meanwhile patients with aggressive lymphomas undergo unpredictable illness courses resulting in goals of care conversations occurring late in the illness trajectory and aggressive care being received in the last 30 days of life Early palliative care alongside usual cancer care has been shown to improve patient outcomes such as symptom burden mood and quality of life in patients with solid tumours eg lung breast or gynecological cancers but has not been explored among patients with blood cancers to date
The goal of this clinical trial is to a brief early palliative care intervention for patients with multiple myeloma and aggressive B cell lymphoma attending the Princess Margaret Cancer Centre The main goals of the study are
To see if it is possible to apply the early palliative care intervention for patients with multiple myeloma and aggressive lymphoma
To see if this early palliative care intervention works well for these patients
To compare patient experiences with early palliative care and usual care
Participants will be randomly assigned to one of two groups one group will receive early palliative care in addition to usual care from their blood cancer doctor and the other group will receive usual care from their blood cancer doctor only All participants will be asked to fill out questionnaires about their symptom burden mood quality of life and satisfaction with care throughout the study Some participants will also be asked to take part in interviews at the end of the trial to answer questions about their experience taking part in the study Researchers will compare the results between the two groups to see if there are any improvements in quality of life for the patients who received early palliative care The researchers will use the results of this study to guide in the development of a larger clinical trial
The goal of this clinical trial is to a brief early palliative care intervention for patients with multiple myeloma and aggressive B cell lymphoma attending the Princess Margaret Cancer Centre The main goals of the study are
To see if it is possible to apply the early palliative care intervention for patients with multiple myeloma and aggressive lymphoma
To see if this early palliative care intervention works well for these patients
To compare patient experiences with early palliative care and usual care
Participants will be randomly assigned to one of two groups one group will receive early palliative care in addition to usual care from their blood cancer doctor and the other group will receive usual care from their blood cancer doctor only All participants will be asked to fill out questionnaires about their symptom burden mood quality of life and satisfaction with care throughout the study Some participants will also be asked to take part in interviews at the end of the trial to answer questions about their experience taking part in the study Researchers will compare the results between the two groups to see if there are any improvements in quality of life for the patients who received early palliative care The researchers will use the results of this study to guide in the development of a larger clinical trial
Detailed Description:
In this study the investigators will test an early palliative care intervention for patients with multiple myeloma and aggressive B cell lymphoma in a randomized phase II trial in which outpatients with multiple myeloma and aggressive lymphoma will be allocated to one of two groups symptom screening alone usual care or early palliative care intervention
Participants will be recruited from multiple myeloma and lymphoma outpatient clinics at the Princess Margaret Cancer Centre Consenting participants will complete questionnaires measuring outcomes of quality of life symptom burden depression and satisfaction with care at recruitment 1 month 2 months and 3 months After the 3-month follow-up time point select participants will complete a one-time semi-structured interview that explores their experiences taking part in the study
The purpose of this phase II trial is to assess the feasibility and preliminary efficacy of early palliative care for outpatients with multiple myeloma and aggressive lymphoma Feasibility criteria are i accrual of at least 80 patients over 12 months ii 60 complete patient-reported outcomes PROs at baseline 1 month 2 months and 3 months and iii in the early palliative care group 60 of patients have at least one visit to the palliative care clinic
Participants will be recruited from multiple myeloma and lymphoma outpatient clinics at the Princess Margaret Cancer Centre Consenting participants will complete questionnaires measuring outcomes of quality of life symptom burden depression and satisfaction with care at recruitment 1 month 2 months and 3 months After the 3-month follow-up time point select participants will complete a one-time semi-structured interview that explores their experiences taking part in the study
The purpose of this phase II trial is to assess the feasibility and preliminary efficacy of early palliative care for outpatients with multiple myeloma and aggressive lymphoma Feasibility criteria are i accrual of at least 80 patients over 12 months ii 60 complete patient-reported outcomes PROs at baseline 1 month 2 months and 3 months and iii in the early palliative care group 60 of patients have at least one visit to the palliative care clinic
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