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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cognitive/Functional Effects, Malignant Neoplasm, Pain

Intervention / Treatment
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* Behavioral: telephone-based intervention
* Other: case management
* Procedure: management of therapy complications
* Procedure: physical therapy
* Other: questionnaire administration
* Procedure: quality-of-life assessment
* Procedure: management of therapy complications
* Procedure: assessment of therapy complications
* Other: educational intervention
* Procedure: management of therapy complications
* Procedure: assessment of therapy complications
* Procedure: assessment of therapy complications


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (enhanced usual care)<br>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<br>* Undergo telephonic monitoring<br>Other: questionnaire administration<br>* Ancillary studies<br>Procedure: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;Procedure: management of therapy complications<br>* Undergo enhanced usual care<br>* Other names: complications of therapy, management of;Procedure: assessment of therapy complications<br>* Undergo enhanced usual care<br>|
| Experimental: Arm II (enhanced usual care, RCM)<br>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<br>* Undergo telephonic monitoring<br>Other: case management<br>* Participate in an individualized conditioning program with an RCM<br>Procedure: physical therapy<br>* Participate in an individualized conditioning program with an RCM<br>* Other names: physiotherapy;Other: questionnaire administration<br>* Ancillary studies<br>Procedure: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;Other: educational intervention<br>* Participate in an individualized conditioning program with an RCM<br>* Other names: intervention, educational;Procedure: management of therapy complications<br>* Undergo enhanced usual care with an RCM<br>* Other names: complications of therapy, management of;Procedure: assessment of therapy complications<br>* Undergo enhanced usual care with an RCM<br>|
| Experimental: Arm III (enhanced usual, RCM, PCM)<br>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<br>* Undergo telephonic monitoring<br>Other: case management<br>* Participate in an individualized conditioning program with an RCM<br>Procedure: management of therapy complications<br>* Undergo enhanced usual care with an RCM and PCM<br>* Other names: complications of therapy, management of;Procedure: physical therapy<br>* Participate in an individualized conditioning program with an RCM<br>* Other names: physiotherapy;Other: questionnaire administration<br>* Ancillary studies<br>Procedure: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;Other: educational intervention<br>* Participate in an individualized conditioning program with an RCM<br>* Other names: intervention, educational;Procedure: assessment of therapy complications<br>* Undergo enhanced usual care with an RCM and PCM<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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] | 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. | From baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain as measured using the Brief Pain Inventory average and total pain interference subscales from baseline [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. | From baseline to 6 months | 
| Health Utility, as measured by the change in EuroQol 5-D (5Q-5D) scale score from baseline | 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. | From baseline to 6 months | 
| Hospitalization frequency | 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. | From registration to 6 months | 
| Hospital length of stay | 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. | From registration to 6 months | 
| Discharge location from hospital | 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. | From registration to 6 months | 
| Planned admission | 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. | From registration to 6 months |