Clinical trial NCT02306252: The CARE Program: CAncer REhabilitation Pilot Study for Older Adults
Official title: LCCC 1409: The CARE Program: CAncer REhabilitation Pilot Study for Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: 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
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2014-12-03
Enrollment: 67
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: To measure the change in Nottingham Extended Activities of Daily Living (NEADL) score from baseline to three months.
timeFrame: 3 months
Secondary outcomes:
measure: To measure the change in Activities of Daily Living from Baseline and 2 months
timeFrame: 2 months
measure: To measure the change in Activities of Daily Living from Baseline and 3 months
timeFrame: 3 months
measure: To measure the change in physical health from Baseline and 3 months
timeFrame: 3 months
measure: To measure the change in physical health from Baseline and 2 months
timeFrame: 2 months
measure: To measure the change in quality of life from Baseline and 2 months
timeFrame: 2 months
measure: To measure the change in quality of life from Baseline and 3 months
timeFrame: 3 months
measure: To measure the change in internalized occupational possibilities from Baseline and 3 months
timeFrame: 3 months
measure: To measure the change in internalized occupational possibilities from Baseline and 2 months
timeFrame: 2 months
measure: To measure the change in cognitive function from Baseline and 2 months
timeFrame: 2 months
measure: To measure the change in cognitive function from Baseline and 3 months
timeFrame: 3 months
measure: To measure the feasibility of the CARE Program
timeFrame: 3 months
measure: To measure the change in balance over the course of the study
timeFrame: 3 months
measure: To measure the change in upper extremity use and ability over the course of the study
timeFrame: 3 months
measure: To measure the change in cognition over the course of the study
timeFrame: 3 months
measure: To measure the change in dynamic gait ability over the course of the study
timeFrame: 3 months
measure: To measure satisfaction with the CARE Program
timeFrame: 3 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: Colorado State University
name: Mackenzi Pergolotti, PhD
role: PRINCIPAL_INVESTIGATOR
References: