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

Not Applicable

Completed

• Conditions: Cognitive/functional Effects; Malignant Neoplasm; Pain
• Interventions: Behavioral: telephone-based intervention; Other: questionnaire administration; Other: case management; Procedure: physical therapy; Procedure: management of therapy complications; Procedure: quality-of-life assessment; Other: educational intervention; Procedure: assessment of therapy complications

• Registration Number: NCT01721343
• Lead Sponsor: 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

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.

Study Timeline

• Study First Submitted: 2012-10-08
• Study First Submitted QC: 2012-11-01
• Study First Posted: 2012-11-04
• Study Start: 2012-11-07
• Primary Completion: 2017-11-14
• Study Completion: 2019-08-03
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 516

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

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Exclusion Criteria

• Patient is within 2 months of a major surgical procedure

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (enhanced usual care)	management of therapy complications	Patients undergo enhanced usual care comprising telephonic monitoring with monthly status reports provided to their oncology care teams for 6 months.
Arm I (enhanced usual care)	telephone-based intervention	Patients undergo enhanced usual care comprising telephonic monitoring with monthly status reports provided to their oncology care teams for 6 months.
Arm I (enhanced usual care)	questionnaire administration	Patients undergo enhanced usual care comprising telephonic monitoring with monthly status reports provided to their oncology care teams for 6 months.
Arm II (enhanced usual care, RCM)	physical therapy	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 II (enhanced usual care, RCM)	quality-of-life assessment	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 II (enhanced usual care, RCM)	management of therapy complications	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 II (enhanced usual care, RCM)	assessment of therapy complications	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 (enhanced usual, RCM, PCM)	management of therapy complications	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.
Arm I (enhanced usual care)	assessment of therapy complications	Patients undergo enhanced usual care comprising telephonic monitoring with monthly status reports provided to their oncology care teams for 6 months.
Arm II (enhanced usual care, RCM)	questionnaire administration	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 II (enhanced usual care, RCM)	telephone-based intervention	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 II (enhanced usual care, RCM)	case management	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 I (enhanced usual care)	quality-of-life assessment	Patients undergo enhanced usual care comprising telephonic monitoring with monthly status reports provided to their oncology care teams for 6 months.
Arm III (enhanced usual, RCM, PCM)	telephone-based intervention	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.
Arm III (enhanced usual, RCM, PCM)	case management	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.
Arm III (enhanced usual, RCM, PCM)	questionnaire administration	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.
Arm II (enhanced usual care, RCM)	educational intervention	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 (enhanced usual, RCM, PCM)	quality-of-life assessment	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.
Arm III (enhanced usual, RCM, PCM)	physical therapy	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.
Arm III (enhanced usual, RCM, PCM)	educational intervention	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.
Arm III (enhanced usual, RCM, PCM)	assessment of therapy complications	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.

Primary Outcome Measures

Name	Time	Method
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]	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

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

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States