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The CARE Program: CAncer REhabilitation Pilot Study for Older Adults (CARE Program)

11. september 2017 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

67

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • North Carolina
      • Chapel Hill, North Carolina, Forente stater, 27599
        • University of North Carolina

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

65 år og eldre (Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: Occupational and Physical Therapy
OT and PT will be arranged for the subject and conducted in a manner as determined by the therapist.
Ingen inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
To measure the change in Nottingham Extended Activities of Daily Living (NEADL) score from baseline to three months.
Tidsramme: 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.
3 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
To measure the change in Activities of Daily Living from Baseline and 2 months
Tidsramme: 2 months
As measured by the Geriatric Assessment
2 months
To measure the change in Activities of Daily Living from Baseline and 3 months
Tidsramme: 3 months
As measured by the Geriatric Assessment
3 months
To measure the change in physical health from Baseline and 3 months
Tidsramme: 3 months
As measured by the Geriatric Assessment
3 months
To measure the change in physical health from Baseline and 2 months
Tidsramme: 2 months
As measured by the Geriatric Assessment
2 months
To measure the change in quality of life from Baseline and 2 months
Tidsramme: 2 months
As measured by the PROMIS assessment
2 months
To measure the change in quality of life from Baseline and 3 months
Tidsramme: 3 months
As measured by the PROMIS assessment
3 months
To measure the change in internalized occupational possibilities from Baseline and 3 months
Tidsramme: 3 months
As measured by the Possibilities for Activity Scale (PActS)
3 months
To measure the change in internalized occupational possibilities from Baseline and 2 months
Tidsramme: 2 months
As measured by the Possibilities for Activity Scale (PActS)
2 months
To measure the change in cognitive function from Baseline and 2 months
Tidsramme: 2 months
As measured by the Blessed Memory Orientation Concentration test
2 months
To measure the change in cognitive function from Baseline and 3 months
Tidsramme: 3 months
As measured by the Blessed Memory Orientation Concentration test
3 months
To measure the feasibility of the CARE Program
Tidsramme: 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.
3 months
To measure the change in balance over the course of the study
Tidsramme: 3 months
Intervention Group Only: As measured by the Berg Balance Scale
3 months
To measure the change in upper extremity use and ability over the course of the study
Tidsramme: 3 months
Intervention Group Only: As measured by the Disability of the Arm, Shoulder and Hand scale
3 months
To measure the change in cognition over the course of the study
Tidsramme: 3 months
Intervention Group Only: As measured by the Montreal Cognitive Assessment
3 months
To measure the change in dynamic gait ability over the course of the study
Tidsramme: 3 months
Intervention Group Only: As measured by the Dynamic Gait Index
3 months
To measure satisfaction with the CARE Program
Tidsramme: 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.
3 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Etterforskere

  • Hovedetterforsker: Mackenzi Pergolotti, PhD, Colorado State University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juni 2014

Primær fullføring (Faktiske)

1. mars 2017

Studiet fullført (Faktiske)

1. mars 2017

Datoer for studieregistrering

Først innsendt

1. desember 2014

Først innsendt som oppfylte QC-kriteriene

2. desember 2014

Først lagt ut (Anslag)

3. desember 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. september 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. september 2017

Sist bekreftet

1. september 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • LCCC1409
  • 14-1159 (Annen identifikator: University of North Carolina IRB)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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Forhold

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