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

Purpose

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 status and preserve performance in patients with advanced cancer

Condition	Intervention
Cognitive/Functional Effects Malignant Neoplasm Pain	Behavioral: telephone-based intervention Other: case management Procedure: management of therapy complications Procedure: physical therapy Other: questionnaire administration Procedure: quality-of-life assessment Procedure: assessment of therapy complications Other: educational intervention

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	MC1193: Collaborative Care to Preserve Performance in Cancer (COPE)

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

Change in Acute Care CAT (APC) score in cancer patients out to 6 months. [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
An overall test using a linear contrast across the three arms will be used. If this is significant then tests between individual pairs of arms will follow. A mixed-effects regression model will allow use of multiple APC measurements per subject while allowing for an appropriate within-subject covariance structure. Time will be incorporated as a continuous variable, a polynomial function, or using assessment-specific indicator variables to determine the most parsimonious model that adequately describes the observed patterns.

Secondary Outcome Measures:

Pain scores concerning general activity relating to quality of life evaluated by the Godin Leisure-Time Exercise Questionnaire (GLTEQ), Functional Assessment of Cancer Therapy - General (FACT-G) and Cancer Behavior Inventory (CBI) out to 6 months. [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
Will be analyzed in a similar manner to the primary analysis. Arms II and III, will be aggregated and adherence variables will be used by time interactions to assess whether the rate of change in APC differs based on participants' "dose" of TCM-RS components to identify potential mediators of TCM-RS benefits.
Pain scores concerning enjoyment relating to quality of life evaluated by the Godin Leisure-Time Exercise Questionnaire (GLTEQ), Functional Assessment of Cancer Therapy - General (FACT-G) and Cancer Behavior Inventory (CBI) out to 6 months. [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
Will be analyzed in a similar manner to the primary analysis. Arms II and III, will be aggregated and adherence variables will be used by time interactions to assess whether the rate of change in APC differs based on participants' "dose" of TCM-RS components to identify potential mediators of TCM-RS benefits.

Estimated Enrollment:	516
Study Start Date:	November 2012
Estimated Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm I (enhanced usual care) Patients undergo enhanced usual care comprising telephonic monitoring, monthly status reports, and an oncology care team for 6 months.	Behavioral: telephone-based intervention Undergo telephonic monitoring Other: questionnaire administration Ancillary studies Procedure: quality-of-life assessment Ancillary studies Other Name: quality of life assessment Procedure: management of therapy complications Undergo enhanced usual care Other Name: complications of therapy, management of Procedure: assessment of therapy complications Undergo enhanced usual care
Experimental: Arm II (enhanced usual care, RCM) Patients undergo enhanced usual care as in Arm I and participate in an individualized conditioning program delivered by a local physical therapist and coordinated by the RCM for 6 months.	Behavioral: telephone-based intervention Undergo telephonic monitoring Other: case management Participate in an individualized conditioning program with an RCM Procedure: physical therapy Participate in an individualized conditioning program with an RCM Other Name: physiotherapy Other: questionnaire administration Ancillary studies Procedure: quality-of-life assessment Ancillary studies Other Name: quality of life assessment Other: educational intervention Participate in an individualized conditioning program with an RCM Other Name: intervention, educational Procedure: management of therapy complications Undergo enhanced usual care with an RCM Other Name: complications of therapy, management of Procedure: assessment of therapy complications Undergo enhanced usual care with an RCM
Experimental: Arm III (enhanced usual, RCM, PCM) Patients undergo enhanced usual care as in Arm I, participate in an individualized conditioning program coordinated by the RCM as in Arm II, and receive optimized pain management through a PCM for 6 months.	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 Other Name: complications of therapy, management of Procedure: physical therapy Participate in an individualized conditioning program with an RCM Other Name: physiotherapy Other: questionnaire administration Ancillary studies Procedure: quality-of-life assessment Ancillary studies Other Name: quality of life assessment Other: educational intervention Participate in an individualized conditioning program with an RCM Other Name: intervention, educational Procedure: assessment of therapy complications Undergo enhanced usual care with an RCM and PCM

Detailed Description:

PRIMARY OBJECTIVES:

I. Establish the comparative effectiveness of the Collaborative Care to Preserve Performance in Cancer (COPE) trial arms in preserving functional status.

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, monthly status reports, and an oncology care team for 6 months.

ARM II: Patients undergo enhanced usual care as in Arm I and participate in an individualized conditioning program delivered by a local physical therapist and coordinated by the Rehabilitation Care Manager (RCM) for 6 months.

ARM III: Patients undergo enhanced usual care as in Arm I, participate in an individualized conditioning program coordinated by the RCM as in Arm II, and receive optimized pain management through a Pain Care Manager (PCM) for 6 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01721343

Locations

United States, Minnesota
Mayo Clinic	Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Mayo Clinic Clinical Trials Office 507-538-7623
Principal Investigator: Andrea L. Cheville, M.D.

Sponsors and Collaborators

Mayo Clinic

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Andrea Cheville, M.D.

Mayo Clinic

More Information

No publications provided

Responsible Party:	Andrea L. Cheville, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:	NCT01721343 History of Changes
Other Study ID Numbers:	MC1193, NCI-2012-01603
Study First Received:	October 8, 2012
Last Updated:	November 1, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on May 22, 2013