Ignite Creation Date:
2024-05-05 @ 11:44 PM
Last Modification Date:
2024-10-26 @ 10:38 AM
Study NCT ID:
NCT01401907
Status:
COMPLETED
Last Update Posted:
2023-10-19
First Post:
2011-07-20
Brief Title:
Early Palliative Care in Advanced Lung and Gastrointestinal Malignancies
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Randomized Study of Early Palliative Care Integrated With Standard Oncology Care Versus Standard Oncology Care Alone in Patients With Advanced Lung and Non-colorectal Gastrointestinal Malignancies
Status:
COMPLETED
Status Verified Date:
2023-10
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:
The purpose of this study is to compare two types of care - standard oncology care and standard oncology care with early palliative care started soon after diagnosis to see which is better for improving the experience of patients and families with advanced lung and non-colorectal GI cancer The study will use questionnaires to measure patients and caregivers quality of life mood coping and understanding of their illness
Detailed Description:
Subjects and their caregiver will complete a baseline questionnaire and then be randomized to a study group
Subjects who are randomized to Standard Oncology Care will follow up with their treating oncologist They will consult with the palliative care team at their request or at the request of the treating oncologist They will complete questionnaires at 12 weeks and 24 weeks after enrollment
Subjects who are randomized to the Standard Oncology Care with Early Palliative Care will meet with a palliative care clinician at their next medical oncology visit or infusion visit They will meet with the palliative care clinician at least every three weeks They will complete questionnaires at 12 and 24 weeks after enrollment
Subjects who are randomized to Standard Oncology Care will follow up with their treating oncologist They will consult with the palliative care team at their request or at the request of the treating oncologist They will complete questionnaires at 12 weeks and 24 weeks after enrollment
Subjects who are randomized to the Standard Oncology Care with Early Palliative Care will meet with a palliative care clinician at their next medical oncology visit or infusion visit They will meet with the palliative care clinician at least every three weeks They will complete questionnaires at 12 and 24 weeks after enrollment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None