The CARE Program: CAncer REhabilitation Pilot Study for Older Adults

NCT ID: NCT02306252

Last Updated: 2017-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2017-03-31

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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Occupational and Physical Therapy

Intervention Type: OTHER

OT and PT will be arranged for the subject and conducted in a manner as determined by the therapist.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Occupational and Physical Therapy

OT and PT will be arranged for the subject and conducted in a manner as determined by the therapist.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mackenzi Pergolotti, PhD

Role: PRINCIPAL_INVESTIGATOR

Colorado State University

Locations

University of North Carolina

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

14-1159

Identifier Type: OTHER

Identifier Source: secondary_id

LCCC1409

Identifier Type: -

Identifier Source: org_study_id