The CARE Program: CAncer REhabilitation Pilot Study for Older Adults

NCT02306252 | Completed DMC

• 2 other identifiers: LCCC140914-1159
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• To measure the change in Activities of Daily Living from Baseline and 2 months

  2 months

• To measure the change in Activities of Daily Living from Baseline and 3 months

  3 months

• To measure the change in physical health from Baseline and 3 months

  3 months

• To measure the change in physical health from Baseline and 2 months

  2 months

• To measure the change in quality of life from Baseline and 2 months

  2 months

Study Arms (2)

CARE Intervention

EXPERIMENTAL

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

CARE Control

NO INTERVENTION

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.

Interventions

Occupational and Physical Therapy OTHER

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

CARE Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Mackenzi Pergolotti, PhD

  Colorado State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2014
• First Posted: December 3, 2014
• Study Start: June 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: September 12, 2017

Record last verified: 2017-09

Locations

US (1)