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

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ClinicalTrials.gov Identifier: NCT01721343
Recruitment Status : Active, not recruiting
First Posted : November 5, 2012
Last Update Posted : January 4, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

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

Condition or disease Intervention/treatment Phase
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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 516 participants
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)
Actual Study Start Date : November 7, 2012
Estimated Primary Completion Date : December 15, 2019
Estimated Study Completion Date : December 15, 2019

Arm Intervention/treatment
Experimental: 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.
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 telephonically by the Fitness Care Manager (FCM) and adapted, as required, by a local physical therapist 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 FCM as in Arm II, and receive optimized pain management through a nurse Pain Care Manager (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




Primary Outcome Measures :
  1. 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] [ Time Frame: From baseline to 6 months ]
    The mean change in the Ambulatory Post-Acute Care Basic Mobility Computer Adaptive Test (AM PAC CAT) score (month 6 minus baseline) and the [95% confidence interval] for patients assigned to each arm regardless of compliance are reported below. The AM PAC CAT is an item response theory-modeled scale that ranges from 0 to infinity. However, the score range of interest for the trial that corresponds to the ability to ambulate and transfer safely and independently (+/- gait aid) is 55 - 66 with higher scores corresponding to better mobility and the MID for improvement being 1.0. For the primary outcome group differences will be assessed over the 6 months of the trial using mixed-effects model repeated measures (MMRM) analysis which will include a random effect for patient, a fixed effect for measurement point (3 months or 6 months), and adjustment for age, gender, baseline value of the outcome variable, cancer type, cancer stage (IV versus other), and time.


Secondary Outcome Measures :
  1. Pain as measured using the Brief Pain Inventory average and total pain interference subscales from baseline [6 months]. [ Time Frame: From baseline to 6 months ]
    The change in the Brief Pain Inventory (BPI) average score and total interference score (Month 6 minus baseline) and the and the [95% confidence interval] for patients assigned to each arm regardless of compliance. The BPI average is a single numerical rating scale (NRS) anchored at 0 and 11. The total inference score is a composite of 6 NRS scales. Higher scores indicate more pain or a worse health state. For both measures the minimally important difference (MID) is population dependent and ranges between 0.5 and 2.0. For the secondary outcome group differences will be assessed over the 6 months of the trial using mixed-effects model repeated measures (MMRM) analysis which will include a random effect for patient, a fixed effect for measurement point (3 months or 6 months), and adjustment for age, gender, baseline value of the outcome variable, cancer type, cancer stage (IV versus other), and time.

  2. Health Utility, as measured by the change in EuroQol 5-D (5Q-5D) scale score from baseline [ Time Frame: From baseline to 6 months ]
    The change in health utility, as measured by the change in EuroQol 5-D (5Q-5D) score from baseline score (Month 6 minus baseline) and the and the [95% confidence interval] for patients assigned to each arm regardless of compliance. The EuroQol 5-D utility ranges from 0 to 1.0 with high values indicating better health states. The minimally important difference (MID) is population dependent and range between 0.5 and 1.0. For the secondary outcome group differences will be assessed over the 6 months of the trial using mixed-effects model repeated measures (MMRM) analysis which will include a random effect for patient, a fixed effect for measurement point (3 months or 6 months), and adjustment for age, gender, baseline value of the outcome variable, cancer type, cancer stage (IV versus other), and time.

  3. Hospitalization frequency [ Time Frame: From registration to 6 months ]
    The count of hospital admission lasting >24 hours. To assess the impact on number of hospitalizations we will use a negative binomial model, with an offset for number of days of follow-up.

  4. Hospital length of stay [ Time Frame: From registration to 6 months ]
    The count of days spent in the hospital for admissions lasting >24 hours. For patients who had at least one hospitalization, the impact of the interventions on the total number of days in hospital will be assessed using mixed effect Poisson analysis.

  5. Discharge location from hospital [ Time Frame: From registration to 6 months ]
    Binary variable describing whether patients were discharged to an inpatient facility (skilled nursing facility, inpatient rehabilitation facility, hospice or long term acute care facility) or home with/without services. Logistic models with random effects for patient will be used to analyze inter-group differences.

  6. Planned admission [ Time Frame: From registration to 6 months ]
    Binary variable describing whether an admission was planned for anti-cancer treatment or unplanned. Logistic models with random effects for patient will be used to analyze inter-group differences.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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 Posted: November 5, 2012    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Neoplasms