Ignite Creation Date:
2024-05-06 @ 1:03 AM
Last Modification Date:
2024-10-26 @ 10:58 AM
Study NCT ID:
NCT01721343
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-07
First Post:
2012-10-08
Brief Title:
Collaborative Targeted Case Management in Improving Functional Status in Patients With Stage III-IV Cancer
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
MC1193 Collaborative Care to Preserve Performance in Cancer COPE
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-11
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:
This randomized clinical trial studies collaborative targeted case management in improving functional status in patients with stage III-IV cancer Collaborative targeted case management may improve functional mobility improve quality of life and reduce pain and health care utilization in patients with advanced cancer
Detailed Description:
PRIMARY OBJECTIVES
I Establish the comparative effectiveness of the Collaborative Care to Preserve Performance in Cancer COPE trial arms in preserving functional mobility
II To assess the comparative cost-effectiveness and cost-utility of the COPE interventions
OUTLINE Patients are randomized to 1 of 3 arms
ARM I Patients undergo enhanced usual care comprising telephonic monitoring with monthly status reports provided to their oncology care teams for 6 months
ARM II Patients undergo enhanced usual care as in Arm I and participate in an individualized conditioning program delivered telephonically by the Fitness Care Manager FCM and adapted as required by a local physical therapist for 6 months
ARM III Patients undergo enhanced usual care as in Arm I participate in an individualized conditioning program coordinated by the FCM as in Arm II and receive optimized pain management through a nurse Pain Care Manager PCM for 6 months
I Establish the comparative effectiveness of the Collaborative Care to Preserve Performance in Cancer COPE trial arms in preserving functional mobility
II To assess the comparative cost-effectiveness and cost-utility of the COPE interventions
OUTLINE Patients are randomized to 1 of 3 arms
ARM I Patients undergo enhanced usual care comprising telephonic monitoring with monthly status reports provided to their oncology care teams for 6 months
ARM II Patients undergo enhanced usual care as in Arm I and participate in an individualized conditioning program delivered telephonically by the Fitness Care Manager FCM and adapted as required by a local physical therapist for 6 months
ARM III Patients undergo enhanced usual care as in Arm I participate in an individualized conditioning program coordinated by the FCM as in Arm II and receive optimized pain management through a nurse Pain Care Manager PCM for 6 months
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01CA163803 | NIH | CTRP Clinical Trial Reporting Program | httpsreporternihgovquickSearchR01CA163803 |
| NCI-2012-01603 | REGISTRY | None | None |
| P30CA015083 | NIH | None | None |