Viewing Study NCT01721343



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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

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