Clinical trial NCT01721343: Collaborative Targeted Case Management in Improving Functional Status in Patients with Stage III-IV Cancer
Official title: MC1193: Collaborative Care to Preserve Performance in Cancer (COPE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive/functional Effects
Malignant Neoplasm
Pain
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-11-04
Enrollment: 516
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Functional mobility, as measured by the change in the Activity Measure for Post Acute Care (AM PAC) Computer Adaptive Test (CAT) from baseline [6 months]
timeFrame: From baseline to 6 months
Secondary outcomes:
measure: Pain as measured using the Brief Pain Inventory average and total pain interference subscales from baseline [6 months].
timeFrame: From baseline to 6 months
measure: Health Utility, as measured by the change in EuroQol 5-D (5Q-5D) scale score from baseline
timeFrame: From baseline to 6 months
measure: Hospitalization frequency
timeFrame: From registration to 6 months
measure: Hospital length of stay
timeFrame: From registration to 6 months
measure: Discharge location from hospital
timeFrame: From registration to 6 months
measure: Planned admission
timeFrame: From registration to 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Andrea Cheville, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cheville AL, Moynihan T, Basford JR, Nyman JA, Tuma ML, Macken DA, Therneau T, Satelel D, Kroenke K. The rationale, design, and methods of a randomized, controlled trial to evaluate the effectiveness of collaborative telecare in preserving function among patients with late stage cancer and hematologic conditions. Contemp Clin Trials. 2018 Jan;64:254-264. doi: 10.1016/j.cct.2017.08.021. Epub 2017 Sep 5.
citation: Cheville AL, Moynihan T, Herrin J, Loprinzi C, Kroenke K. Effect of Collaborative Telerehabilitation on Functional Impairment and Pain Among Patients With Advanced-Stage Cancer: A Randomized Clinical Trial. JAMA Oncol. 2019 May 1;5(5):644-652. doi: 10.1001/jamaoncol.2019.0011.