NCT01721343

Collaborative Targeted Case Management in Improving Functional Status in Patients With Stage III-IV Cancer

MC1193: Collaborative Care to Preserve Performance in Cancer (COPE)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 516 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cognitive/Functional Effects
• Malignant Neoplasm
• Pain

Interventions

Type	Name	Description
BEHAVIORAL	telephone-based intervention	Undergo telephonic monitoring
OTHER	case management	Participate in an individualized conditioning program with an RCM
PROCEDURE	management of therapy complications	Undergo enhanced usual care with an RCM and PCM
PROCEDURE	physical therapy	Participate in an individualized conditioning program with an RCM
OTHER	questionnaire administration	Ancillary studies
PROCEDURE	quality-of-life assessment	Ancillary studies
PROCEDURE	management of therapy complications	Undergo enhanced usual care
PROCEDURE	assessment of therapy complications	Undergo enhanced usual care
OTHER	educational intervention	Participate in an individualized conditioning program with an RCM
PROCEDURE	management of therapy complications	Undergo enhanced usual care with an RCM
PROCEDURE	assessment of therapy complications	Undergo enhanced usual care with an RCM
PROCEDURE	assessment of therapy complications	Undergo enhanced usual care with an RCM and PCM

Timeline

• Start date: 2012-11-07
• Primary completion: 2017-11-14
• Completion: 2019-08-03
• First posted: 2012-11-05
• Last updated: 2026-03-16

Locations

1 site across 1 country: United States