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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01721343
First Posted: November 5, 2012
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: MC1193: Collaborative Care to Preserve Performance in Cancer (COPE)

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 ]
    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 ]
    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 ]
    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.


Enrollment: 516
Actual Study Start Date: November 7, 2012
Study Completion Date: November 15, 2017
Primary Completion Date: November 15, 2017 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01721343


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Principal Investigator: Andrea Cheville, M.D. Mayo Clinic
  More Information

Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT01721343     History of Changes
Other Study ID Numbers: MC1193
NCI-2012-01603 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: October 8, 2012
First Posted: November 5, 2012
Last Update Posted: November 17, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Neoplasms