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


N/A
18 Years
N/A
Not Enrolling
Both
Cognitive/Functional Effects, Malignant Neoplasm, Pain

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Change in Acute Care CAT (APC) score in cancer patients out to 6 months.

Outcome Description:

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.

Outcome Time Frame:

Baseline to 6 months

Safety Issue:

No

Principal Investigator

Andrea Cheville, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

MC1193

NCT ID:

NCT01721343

Start Date:

November 2012

Completion Date:

Related Keywords:

  • Cognitive/Functional Effects
  • Malignant Neoplasm
  • Pain
  • Neoplasms

Name

Location
Mayo Clinic Rochester, Minnesota  55905