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

11 september 2017 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Werkelijk)

67

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • North Carolina
      • Chapel Hill, North Carolina, Verenigde Staten, 27599
        • University of North Carolina

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

65 jaar en ouder (Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Ander: Occupational and Physical Therapy
OT and PT will be arranged for the subject and conducted in a manner as determined by the therapist.
Geen tussenkomst: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
To measure the change in Nottingham Extended Activities of Daily Living (NEADL) score from baseline to three months.
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
To measure the change in Activities of Daily Living from Baseline and 2 months
Tijdsspanne: 2 months
As measured by the Geriatric Assessment
2 months
To measure the change in Activities of Daily Living from Baseline and 3 months
Tijdsspanne: 3 months
As measured by the Geriatric Assessment
3 months
To measure the change in physical health from Baseline and 3 months
Tijdsspanne: 3 months
As measured by the Geriatric Assessment
3 months
To measure the change in physical health from Baseline and 2 months
Tijdsspanne: 2 months
As measured by the Geriatric Assessment
2 months
To measure the change in quality of life from Baseline and 2 months
Tijdsspanne: 2 months
As measured by the PROMIS assessment
2 months
To measure the change in quality of life from Baseline and 3 months
Tijdsspanne: 3 months
As measured by the PROMIS assessment
3 months
To measure the change in internalized occupational possibilities from Baseline and 3 months
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 3 months
As measured by the Blessed Memory Orientation Concentration test
3 months
To measure the feasibility of the CARE Program
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 3 months
Intervention Group Only: As measured by the Dynamic Gait Index
3 months
To measure satisfaction with the CARE Program
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Onderzoekers

  • Hoofdonderzoeker: Mackenzi Pergolotti, PhD, Colorado State University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 juni 2014

Primaire voltooiing (Werkelijk)

1 maart 2017

Studie voltooiing (Werkelijk)

1 maart 2017

Studieregistratiedata

Eerst ingediend

1 december 2014

Eerst ingediend dat voldeed aan de QC-criteria

2 december 2014

Eerst geplaatst (Schatting)

3 december 2014

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 september 2017

Laatste update ingediend die voldeed aan QC-criteria

11 september 2017

Laatst geverifieerd

1 september 2017

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • LCCC1409
  • 14-1159 (Andere identificatie: University of North Carolina IRB)

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