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

11. september 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

67

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599
        • University of North Carolina

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

65 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: Occupational and Physical Therapy
OT and PT will be arranged for the subject and conducted in a manner as determined by the therapist.
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Efterforskere

  • Ledende efterforsker: Mackenzi Pergolotti, PhD, Colorado State University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juni 2014

Primær færdiggørelse (Faktiske)

1. marts 2017

Studieafslutning (Faktiske)

1. marts 2017

Datoer for studieregistrering

Først indsendt

1. december 2014

Først indsendt, der opfyldte QC-kriterier

2. december 2014

Først opslået (Skøn)

3. december 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. september 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. september 2017

Sidst verificeret

1. september 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

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

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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