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Completed

NCT Number: NCT02306252

The CARE Program: CAncer REhabilitation Pilot Study for Older Adults

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.

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Key information

Conditions

Cancer Neoplasms

Age range

65 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Occupational and Physical Therapy

Other

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

Primary outcomes

  1. To measure the change in Nottingham Extended Activities of Daily Living (NEADL) score from baseline to three months.

    Time frame: 3 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.

Secondary outcomes

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

    Time frame: 2 months

    As measured by the Geriatric Assessment

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

    Time frame: 3 months

    As measured by the Geriatric Assessment

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

    Time frame: 3 months

    As measured by the Geriatric Assessment

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

    Time frame: 2 months

    As measured by the Geriatric Assessment

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

    Time frame: 2 months

    As measured by the PROMIS assessment

  6. To measure the change in quality of life from Baseline and 3 months

    Time frame: 3 months

    As measured by the PROMIS assessment

  7. To measure the change in internalized occupational possibilities from Baseline and 3 months

    Time frame: 3 months

    As measured by the Possibilities for Activity Scale (PActS)

  8. To measure the change in internalized occupational possibilities from Baseline and 2 months

    Time frame: 2 months

    As measured by the Possibilities for Activity Scale (PActS)

  9. To measure the change in cognitive function from Baseline and 2 months

    Time frame: 2 months

    As measured by the Blessed Memory Orientation Concentration test

  10. To measure the change in cognitive function from Baseline and 3 months

    Time frame: 3 months

    As measured by the Blessed Memory Orientation Concentration test

  11. To measure the feasibility of the CARE Program

    Time frame: 3 months

    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.

  12. To measure the change in balance over the course of the study

    Time frame: 3 months

    Intervention Group Only: As measured by the Berg Balance Scale

  13. To measure the change in upper extremity use and ability over the course of the study

    Time frame: 3 months

    Intervention Group Only: As measured by the Disability of the Arm, Shoulder and Hand scale

  14. To measure the change in cognition over the course of the study

    Time frame: 3 months

    Intervention Group Only: As measured by the Montreal Cognitive Assessment

  15. To measure the change in dynamic gait ability over the course of the study

    Time frame: 3 months

    Intervention Group Only: As measured by the Dynamic Gait Index

  16. To measure satisfaction with the CARE Program

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Registry information

Official study title

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

Acronym: CARE Program

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 3, 2014
Registry last updated
Sep 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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