The CARE Program: CAncer REhabilitation Pilot Study for Older Adults (CARE Program)
11. září 2017 aktualizováno: UNC Lineberger Comprehensive Cancer Center
LCCC 1409: 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.
Přehled studie
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
67
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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North Carolina
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Chapel Hill, North Carolina, Spojené státy, 27599
- University of North Carolina
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
65 let a starší (Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Ženský
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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.
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OT and PT will be arranged for the subject and conducted in a manner as determined by the therapist.
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Žádný zásah: 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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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To measure the change in Nottingham Extended Activities of Daily Living (NEADL) score from baseline to three months.
Časové okno: 3 months
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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.
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3 months
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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To measure the change in Activities of Daily Living from Baseline and 2 months
Časové okno: 2 months
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As measured by the Geriatric Assessment
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2 months
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To measure the change in Activities of Daily Living from Baseline and 3 months
Časové okno: 3 months
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As measured by the Geriatric Assessment
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3 months
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To measure the change in physical health from Baseline and 3 months
Časové okno: 3 months
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As measured by the Geriatric Assessment
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3 months
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To measure the change in physical health from Baseline and 2 months
Časové okno: 2 months
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As measured by the Geriatric Assessment
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2 months
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To measure the change in quality of life from Baseline and 2 months
Časové okno: 2 months
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As measured by the PROMIS assessment
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2 months
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To measure the change in quality of life from Baseline and 3 months
Časové okno: 3 months
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As measured by the PROMIS assessment
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3 months
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To measure the change in internalized occupational possibilities from Baseline and 3 months
Časové okno: 3 months
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As measured by the Possibilities for Activity Scale (PActS)
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3 months
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To measure the change in internalized occupational possibilities from Baseline and 2 months
Časové okno: 2 months
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As measured by the Possibilities for Activity Scale (PActS)
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2 months
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To measure the change in cognitive function from Baseline and 2 months
Časové okno: 2 months
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As measured by the Blessed Memory Orientation Concentration test
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2 months
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To measure the change in cognitive function from Baseline and 3 months
Časové okno: 3 months
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As measured by the Blessed Memory Orientation Concentration test
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3 months
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To measure the feasibility of the CARE Program
Časové okno: 3 months
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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.
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3 months
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To measure the change in balance over the course of the study
Časové okno: 3 months
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Intervention Group Only: As measured by the Berg Balance Scale
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3 months
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To measure the change in upper extremity use and ability over the course of the study
Časové okno: 3 months
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Intervention Group Only: As measured by the Disability of the Arm, Shoulder and Hand scale
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3 months
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To measure the change in cognition over the course of the study
Časové okno: 3 months
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Intervention Group Only: As measured by the Montreal Cognitive Assessment
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3 months
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To measure the change in dynamic gait ability over the course of the study
Časové okno: 3 months
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Intervention Group Only: As measured by the Dynamic Gait Index
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3 months
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To measure satisfaction with the CARE Program
Časové okno: 3 months
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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.
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3 months
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Mackenzi Pergolotti, PhD, Colorado State University
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. června 2014
Primární dokončení (Aktuální)
1. března 2017
Dokončení studie (Aktuální)
1. března 2017
Termíny zápisu do studia
První předloženo
1. prosince 2014
První předloženo, které splnilo kritéria kontroly kvality
2. prosince 2014
První zveřejněno (Odhad)
3. prosince 2014
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
12. září 2017
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
11. září 2017
Naposledy ověřeno
1. září 2017
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- LCCC1409
- 14-1159 (Jiný identifikátor: University of North Carolina IRB)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Occupational and Physical Therapy
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University of Alabama at BirminghamCenters for Disease Control and PreventionNáborRodinné vztahy | PlíseňSpojené státy