- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02306252
The CARE Program: CAncer REhabilitation Pilot Study for Older Adults (CARE Program)
11. September 2017 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
67
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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North Carolina
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Chapel Hill, North Carolina, Vereinigte Staaten, 27599
- University of North Carolina
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
65 Jahre und älter (Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Weiblich
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 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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Kein Eingriff: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
To measure the change in Nottingham Extended Activities of Daily Living (NEADL) score from baseline to three months.
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
To measure the change in Activities of Daily Living from Baseline and 2 months
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Mackenzi Pergolotti, PhD, Colorado State University
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Juni 2014
Primärer Abschluss (Tatsächlich)
1. März 2017
Studienabschluss (Tatsächlich)
1. März 2017
Studienanmeldedaten
Zuerst eingereicht
1. Dezember 2014
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
2. Dezember 2014
Zuerst gepostet (Schätzen)
3. Dezember 2014
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
12. September 2017
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
11. September 2017
Zuletzt verifiziert
1. September 2017
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- LCCC1409
- 14-1159 (Andere Kennung: University of North Carolina IRB)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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