Mackenzi Pergolotti1, Allison M Deal2, Grant R Williams3, Ashley L Bryant4, Bryce B Reeve5, Hyman B Muss6. 1. Cancer Care Quality Training Program, 1102G McGavran-Greenberg Hall, CB# 7411, The University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; Department of Health Policy and Management, 1102G McGavran-Greenberg Hall, CB# 7411, The University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA. Electronic address: pergolot@email.unc.edu. 2. Biostatistics Core Facility, The University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center, 170 Manning Drive, Chapel Hill, NC 27599, USA. Electronic address: Allison_Deal@med.unc.edu. 3. Geriatric Oncology Program, The University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center, 170 Manning Drive, Chapel Hill, NC 27599, USA. Electronic address: Grant.Williams@unchealth.unc.edu. 4. School of Nursing, The University of North Carolina at Chapel Hill, Carrington Hall, CB #7460, Chapel Hill, NC 27599-7460, USA. Electronic address: anleak@email.unc.edu. 5. Department of Health Policy and Management, 1101D McGavran-Greenberg Hall, Campus Box 7411, The University of North Carolina at Chapel Hill, Gillings School of Global Public Health, 135 Dauer Drive, Chapel Hill, NC 27599, USA. Electronic address: bbreeve@email.unc.edu. 6. Geriatric Oncology Program, The University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center, 170 Manning Drive, Chapel Hill, NC 27599, USA. Electronic address: hyman_muss@med.unc.edu.
Abstract
BACKGROUND: Large numbers of older adults (aged 65years or older) are surviving cancer; however, many survivors report decreased quality of life (QOL) and limitations in activities of daily living (ADL) and instrumental activities of daily living (IADL) both during and after treatment [1-3]. Occupational and physical therapy (OT/PT) are services focused on improving functional status and QOL that are largely unexplored and underutilized in cancer survivorship care [4,5]. METHODS/ DESIGN: This is a randomized, single-blind, two-arm, single institution pilot study. Eighty-two patients will be recruited from a university-affiliated outpatient oncology clinic. Inclusion criteria include the following: aged 65years or older, diagnosis of cancer within 5years, English speaking, has at least one functional deficit, and able to safely participate in an outpatient rehabilitation program. Exclusion criteria are: currently receiving rehabilitation or eligible for hospice. Consented patients will be randomized into two groups: (1) the CARE (CAncer REhabilitation) Program consisting of outpatient OT/PT and (2) standard of care. PRIMARY OUTCOME: change in Nottingham Extended Activities of Daily Living (NEADL) scores from baseline to 3months between CARE and control. DISCUSSION: This study is one of the first RCTs aimed at examining the effect of OT/PT in older adults with cancer. If positive, findings from this study will suggest the potential for outpatient OT/PT to improve the functional ability and QOL of older adults with cancer.
RCT Entities:
BACKGROUND: Large numbers of older adults (aged 65years or older) are surviving cancer; however, many survivors report decreased quality of life (QOL) and limitations in activities of daily living (ADL) and instrumental activities of daily living (IADL) both during and after treatment [1-3]. Occupational and physical therapy (OT/PT) are services focused on improving functional status and QOL that are largely unexplored and underutilized in cancer survivorship care [4,5]. METHODS/ DESIGN: This is a randomized, single-blind, two-arm, single institution pilot study. Eighty-two patients will be recruited from a university-affiliated outpatient oncology clinic. Inclusion criteria include the following: aged 65years or older, diagnosis of cancer within 5years, English speaking, has at least one functional deficit, and able to safely participate in an outpatient rehabilitation program. Exclusion criteria are: currently receiving rehabilitation or eligible for hospice. Consented patients will be randomized into two groups: (1) the CARE (CAncer REhabilitation) Program consisting of outpatient OT/PT and (2) standard of care. PRIMARY OUTCOME: change in Nottingham Extended Activities of Daily Living (NEADL) scores from baseline to 3months between CARE and control. DISCUSSION: This study is one of the first RCTs aimed at examining the effect of OT/PT in older adults with cancer. If positive, findings from this study will suggest the potential for outpatient OT/PT to improve the functional ability and QOL of older adults with cancer.
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