Collaborative Targeted Case Management in Improving Functional Status in Patients with Stage III-IV Cancer
NCT ID: NCT01721343
Last Updated: 2024-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
516 participants
INTERVENTIONAL
2012-11-07
2019-08-03
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I (enhanced usual care)
Patients undergo enhanced usual care comprising telephonic monitoring with monthly status reports provided to their oncology care teams for 6 months.
telephone-based intervention
Undergo telephonic monitoring
questionnaire administration
Ancillary studies
quality-of-life assessment
Ancillary studies
management of therapy complications
Undergo enhanced usual care
assessment of therapy complications
Undergo enhanced usual care
Arm II (enhanced usual care, RCM)
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.
telephone-based intervention
Undergo telephonic monitoring
case management
Participate in an individualized conditioning program with an RCM
physical therapy
Participate in an individualized conditioning program with an RCM
questionnaire administration
Ancillary studies
quality-of-life assessment
Ancillary studies
educational intervention
Participate in an individualized conditioning program with an RCM
management of therapy complications
Undergo enhanced usual care with an RCM
assessment of therapy complications
Undergo enhanced usual care with an RCM
Arm III (enhanced usual, RCM, PCM)
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.
telephone-based intervention
Undergo telephonic monitoring
case management
Participate in an individualized conditioning program with an RCM
management of therapy complications
Undergo enhanced usual care with an RCM and PCM
physical therapy
Participate in an individualized conditioning program with an RCM
questionnaire administration
Ancillary studies
quality-of-life assessment
Ancillary studies
educational intervention
Participate in an individualized conditioning program with an RCM
assessment of therapy complications
Undergo enhanced usual care with an RCM and PCM
Interventions
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telephone-based intervention
Undergo telephonic monitoring
case management
Participate in an individualized conditioning program with an RCM
management of therapy complications
Undergo enhanced usual care with an RCM and PCM
physical therapy
Participate in an individualized conditioning program with an RCM
questionnaire administration
Ancillary studies
quality-of-life assessment
Ancillary studies
management of therapy complications
Undergo enhanced usual care
assessment of therapy complications
Undergo enhanced usual care
educational intervention
Participate in an individualized conditioning program with an RCM
management of therapy complications
Undergo enhanced usual care with an RCM
assessment of therapy complications
Undergo enhanced usual care with an RCM
assessment of therapy complications
Undergo enhanced usual care with an RCM and PCM
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Andrea Cheville, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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References
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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.
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.
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2012-01603
Identifier Type: REGISTRY
Identifier Source: secondary_id
MC1193
Identifier Type: -
Identifier Source: org_study_id
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