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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Mayo Clinic
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01721343
First received: October 8, 2012
Last updated: September 12, 2014
Last verified: September 2014
  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:


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: December 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Mayo Clinic Clinical Trials Office    855-776-0015      
Principal Investigator: Andrea L. Cheville, M.D.         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Andrea Cheville, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: 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: September 12, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on October 21, 2014