The CARE Program: CAncer REhabilitation Pilot Study for Older Adults

Cancer Clinical Trial

— CARE Program  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02306252
• Other study ID #: LCCC1409
• Secondary ID: 14-1159
• Status: Completed
• Phase: N/A
• First received: December 1, 2014
• Last updated: September 11, 2017
• Start date: June 2014
• Est. completion date: March 2017

Study information

• Verified date: September 2017
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Occupational and Physical Therapy
OT and PT will be arranged for the subject and conducted in a manner as determined by the therapist.

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To measure the change in Activities of Daily Living from Baseline and 2 months	As measured by the Geriatric Assessment	2 months
Secondary	To measure the change in Activities of Daily Living from Baseline and 3 months	As measured by the Geriatric Assessment	3 months
Secondary	To measure the change in physical health from Baseline and 3 months	As measured by the Geriatric Assessment	3 months
Secondary	To measure the change in physical health from Baseline and 2 months	As measured by the Geriatric Assessment	2 months
Secondary	To measure the change in quality of life from Baseline and 2 months	As measured by the PROMIS assessment	2 months
Secondary	To measure the change in quality of life from Baseline and 3 months	As measured by the PROMIS assessment	3 months
Secondary	To measure the change in internalized occupational possibilities from Baseline and 3 months	As measured by the Possibilities for Activity Scale (PActS)	3 months
Secondary	To measure the change in internalized occupational possibilities from Baseline and 2 months	As measured by the Possibilities for Activity Scale (PActS)	2 months
Secondary	To measure the change in cognitive function from Baseline and 2 months	As measured by the Blessed Memory Orientation Concentration test	2 months
Secondary	To measure the change in cognitive function from Baseline and 3 months	As measured by the Blessed Memory Orientation Concentration test	3 months
Secondary	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
Secondary	To measure the change in balance over the course of the study	Intervention Group Only: As measured by the Berg Balance Scale	3 months
Secondary	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
Secondary	To measure the change in cognition over the course of the study	Intervention Group Only: As measured by the Montreal Cognitive Assessment	3 months
Secondary	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
Secondary	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