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

NCT01721343 | Completed DMC

• 3 other identifiers: MC1193R01CA16380311-008151
• Study Type: interventional
• Target: 516
• Locations: 1 country
• Sites: 1

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

Conditions

Malignant Neoplasm; Pain; Cognitive/Functional Effects

Outcome Measures

Primary Outcomes (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]

  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 Outcomes (6)

• Pain as measured using the Brief Pain Inventory average and total pain interference subscales from baseline [6 months].

  From baseline to 6 months

• Health Utility, as measured by the change in EuroQol 5-D (5Q-5D) scale score from baseline

  From baseline to 6 months

• Hospitalization frequency

  From registration to 6 months

• Hospital length of stay

  From registration to 6 months

• Discharge location from hospital

  From registration to 6 months

Study Arms (3)

Arm I (enhanced usual care)

EXPERIMENTAL

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; Other: questionnaire administration; Procedure: quality-of-life assessment; Procedure: management of therapy complications; Procedure: assessment of therapy complications

Arm II (enhanced usual care, RCM)

EXPERIMENTAL

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; Other: case management; Procedure: physical therapy; Other: questionnaire administration; Procedure: quality-of-life assessment; Other: educational intervention; Procedure: management of therapy complications; Procedure: assessment of therapy complications

Arm III (enhanced usual, RCM, PCM)

EXPERIMENTAL

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; Other: case management; Procedure: management of therapy complications; Procedure: physical therapy; Other: questionnaire administration; Procedure: quality-of-life assessment; Other: educational intervention; Procedure: assessment of therapy complications

Interventions

telephone-based intervention BEHAVIORAL

Undergo telephonic monitoring

Arm I (enhanced usual care); Arm II (enhanced usual care, RCM); Arm III (enhanced usual, RCM, PCM)

case management OTHER

Participate in an individualized conditioning program with an RCM

Arm II (enhanced usual care, RCM); Arm III (enhanced usual, RCM, PCM)

management of therapy complications PROCEDURE

Undergo enhanced usual care with an RCM and PCM

Also known as: complications of therapy, management of

Arm III (enhanced usual, RCM, PCM)

physical therapy PROCEDURE

Participate in an individualized conditioning program with an RCM

Also known as: physiotherapy

Arm II (enhanced usual care, RCM); Arm III (enhanced usual, RCM, PCM)

questionnaire administration OTHER

Ancillary studies

Arm I (enhanced usual care); Arm II (enhanced usual care, RCM); Arm III (enhanced usual, RCM, PCM)

quality-of-life assessment PROCEDURE

Ancillary studies

Also known as: quality of life assessment

Arm I (enhanced usual care); Arm II (enhanced usual care, RCM); Arm III (enhanced usual, RCM, PCM)

assessment of therapy complications PROCEDURE

Undergo enhanced usual care

Arm I (enhanced usual care)

educational intervention OTHER

Participate in an individualized conditioning program with an RCM

Also known as: intervention, educational

Arm II (enhanced usual care, RCM); Arm III (enhanced usual, RCM, PCM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient is within 2 months of a major surgical procedure

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• 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.

  PMID: 28887068 BACKGROUND

• 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.

  PMID: 30946436 RESULT

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Neoplasms; Pain

Interventions

Case Management; Physical Therapy Modalities; Early Intervention, Educational; Methods

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration; Therapeutics; Rehabilitation; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Investigative Techniques

Study Officials

• Andrea Cheville, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2012
• First Posted: November 5, 2012
• Study Start: November 7, 2012
• Primary Completion: November 14, 2017
• Study Completion: August 3, 2019
• Last Updated: March 16, 2026

Record last verified: 2024-11

Locations

US (1)