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

11 september 2017 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

67

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • North Carolina
      • Chapel Hill, North Carolina, Förenta staterna, 27599
        • University of North Carolina

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

65 år och äldre (Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Övrig: Occupational and Physical Therapy
OT and PT will be arranged for the subject and conducted in a manner as determined by the therapist.
Inget ingripande: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
To measure the change in Nottingham Extended Activities of Daily Living (NEADL) score from baseline to three months.
Tidsram: 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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Utredare

  • Huvudutredare: Mackenzi Pergolotti, PhD, Colorado State University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 juni 2014

Primärt slutförande (Faktisk)

1 mars 2017

Avslutad studie (Faktisk)

1 mars 2017

Studieregistreringsdatum

Först inskickad

1 december 2014

Först inskickad som uppfyllde QC-kriterierna

2 december 2014

Första postat (Uppskatta)

3 december 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

12 september 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 september 2017

Senast verifierad

1 september 2017

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • LCCC1409
  • 14-1159 (Annan identifierare: University of North Carolina IRB)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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