The CARE Program: CAncer REhabilitation Pilot Study for Older Adults

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Other: Occupational and Physical Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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Female

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CARE Intervention<br>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<br>* OT and PT will be arranged for the subject and conducted in a manner as determined by the therapist.<br>|
| No Intervention: CARE Control<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Older Adult, Geriatric, Function, Functional Deficit, Occupational Therapy, Physical Therapy, Supportive Care, Oncology, physiology, Geriatric Assessment, Health Services for the Aged, Physical Therapy Specialty