The CARE Program: CAncer REhabilitation Pilot Study for Older Adults (CARE Program)

LCCC 1409: The CARE Program: CAncer REhabilitation Pilot Study for Older Adults

The CARE Program is a randomized trial of a cancer rehabilitation program designed to help older cancer patients who have shown to have a loss of function.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: Occupational and Physical Therapy

Detailed Description

This is a prospective, two-arm, single-center randomized controlled pilot trial of a cancer rehabilitation program for older adults, titled the 'CARE program,' which is designed to maintain and/or improve functional status and quality of life in older adults diagnosed with cancer. Adults aged 65 years and older with cancer will be screened with a Geriatric Assessment (GA) for eligibility. Although breast cancer patients will be eligible, this study will focus primarily on other types of cancers. Adults with at least one functional deficit --defined as impairment in ability to perform activities of daily living or instrumental activities of daily living, cognitive decline or balance -- will be randomized to either the intervention (CARE program) or to the control arm (Supportive care services information only). Both arms will receive a brochure about the supportive care program to provide patients who we've identified as having deficits with information about auxiliary services available and because the intent is to limit the difference between the groups. We hypothesize that patients who participate in the CARE program will maintain or improve functional status and quality of life when compared to supportive care services information only.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Aged 65 years or older
• Has an outpatient appointment within UNC Chapel Hill Lineberger Comprehensive Cancer Center
• Diagnosis of cancer within last two years.
• Has a life expectancy of 12 months or longer. All cancer types are included.
• English speaking
• Willing to complete the UNC GA
• Has at least one functional deficit as defined by GA screen
• Understands study design, risks, and benefits and have signed informed consent
• Willing to be randomized into either study arm
• Ability to safely participate in outpatient rehabilitation program

Exclusion Criteria:

• Unable to safely participate in outpatient rehabilitation.
• Currently receiving rehabilitation.
• Any participant who has urologic cancer or is enrolled in a competing trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CARE Intervention; This group will be contacted to make an appointment for outpatient Occupational and Physical therapy. The therapist will determine the type, frequency and length of treatment. Follow up phone calls will be made to ensure appointments are made, kept and rescheduled as needed.	Other: Occupational and Physical Therapy; OT and PT will be arranged for the subject and conducted in a manner as determined by the therapist.
No Intervention: CARE Control; Patients randomized to this arm will receive contact information and a brochure outlining the services available within the supportive care program. The study coordinator will provide the information based on their results and assist the patient with contacting the program if desired.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To measure the change in Nottingham Extended Activities of Daily Living (NEADL) score from baseline to three months.	Compare the change in NEADL scores from baseline to 3 months between patients who receive the CARE program (intervention) and those in the control arm.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To measure the change in Activities of Daily Living from Baseline and 2 months	As measured by the Geriatric Assessment	2 months
To measure the change in Activities of Daily Living from Baseline and 3 months	As measured by the Geriatric Assessment	3 months
To measure the change in physical health from Baseline and 3 months	As measured by the Geriatric Assessment	3 months
To measure the change in physical health from Baseline and 2 months	As measured by the Geriatric Assessment	2 months
To measure the change in quality of life from Baseline and 2 months	As measured by the PROMIS assessment	2 months
To measure the change in quality of life from Baseline and 3 months	As measured by the PROMIS assessment	3 months
To measure the change in internalized occupational possibilities from Baseline and 3 months	As measured by the Possibilities for Activity Scale (PActS)	3 months
To measure the change in internalized occupational possibilities from Baseline and 2 months	As measured by the Possibilities for Activity Scale (PActS)	2 months
To measure the change in cognitive function from Baseline and 2 months	As measured by the Blessed Memory Orientation Concentration test	2 months
To measure the change in cognitive function from Baseline and 3 months	As measured by the Blessed Memory Orientation Concentration test	3 months
To measure the feasibility of the CARE Program	To describe the feasibility of the CARE program by reporting enrollment and retention as defined by (1) percent eligible who agree to participate (2) percent in each group that completed follow-up measures at 2 and 3 months and (3) percent of patients in CARE program who go to 70% of appointments.	3 months
To measure the change in balance over the course of the study	Intervention Group Only: As measured by the Berg Balance Scale	3 months
To measure the change in upper extremity use and ability over the course of the study	Intervention Group Only: As measured by the Disability of the Arm, Shoulder and Hand scale	3 months
To measure the change in cognition over the course of the study	Intervention Group Only: As measured by the Montreal Cognitive Assessment	3 months
To measure the change in dynamic gait ability over the course of the study	Intervention Group Only: As measured by the Dynamic Gait Index	3 months
To measure satisfaction with the CARE Program	To evaluate the program a short interview will be completed with CARE team to determine what worked well, what didn't and suggested changes/improvements for CARE program after completion of project.	3 months

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Investigators: Principal Investigator: Mackenzi Pergolotti, PhD, Colorado State University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: December 1, 2014
• First Submitted That Met QC Criteria: December 2, 2014
• First Posted (Estimate): December 3, 2014

Study Record Updates

• Last Update Posted (Actual): September 12, 2017
• Last Update Submitted That Met QC Criteria: September 11, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Cancer; Physical Therapy; Occupational Therapy; Supportive Care; Oncology; Physical Therapy Specialty; Function; Geriatric; Health Services for the Aged; physiology; Geriatric Assessment; Older Adult; Functional Deficit
• Other Study ID Numbers: LCCC1409; 14-1159 (Other Identifier: University of North Carolina IRB)