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

Mayo Clinic

Status

Completed

Conditions

Malignant Neoplasm

Cognitive/functional Effects

Pain

Treatments

Procedure: quality-of-life assessment

Procedure: assessment of therapy complications

Other: case management

Behavioral: telephone-based intervention

Procedure: management of therapy complications

Other: educational intervention

Other: questionnaire administration

Procedure: physical therapy

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01721343

R01CA163803 (U.S. NIH Grant/Contract)

NCI-2012-01603 (Registry Identifier)

MC1193

Details and patient eligibility

About

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

Full 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.

Enrollment

516 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of stage III or stage IV cancer
Life expectancy > 6 months
Ambulatory Post Acute Care (APC) score between 53 and 66
Ability to complete questionnaire(s) by themselves or with assistance
Provide informed written consent
Have working phone to communicate with study team
Fluent in English
Sufficient auditory acuity
Intact cognitive status

Exclusion criteria

Patient is within 2 months of a major surgical procedure

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

516 participants in 3 patient groups

Arm I (enhanced usual care)

Experimental group

Description:

Patients undergo enhanced usual care comprising telephonic monitoring with monthly status reports provided to their oncology care teams for 6 months.

Treatment:

Procedure: management of therapy complications

Other: questionnaire administration

Procedure: assessment of therapy complications

Procedure: management of therapy complications

Behavioral: telephone-based intervention

Procedure: assessment of therapy complications

Procedure: quality-of-life assessment

Arm II (enhanced usual care, RCM)

Experimental group

Description:

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.

Treatment:

Procedure: management of therapy complications

Procedure: physical therapy

Other: questionnaire administration

Procedure: assessment of therapy complications

Procedure: management of therapy complications

Other: educational intervention

Other: case management

Behavioral: telephone-based intervention

Procedure: assessment of therapy complications

Procedure: quality-of-life assessment

Arm III (enhanced usual, RCM, PCM)

Experimental group

Description:

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.

Treatment:

Procedure: management of therapy complications

Procedure: physical therapy

Other: questionnaire administration

Procedure: assessment of therapy complications

Procedure: management of therapy complications

Other: educational intervention

Other: case management

Behavioral: telephone-based intervention

Procedure: assessment of therapy complications

Procedure: quality-of-life assessment