The CARE Program: CAncer REhabilitation Pilot Study for Older Adults (CARE Program)
11 septembre 2017 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
67
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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North Carolina
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Chapel Hill, North Carolina, États-Unis, 27599
- University of North Carolina
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
65 ans et plus (Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Aucune intervention: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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To measure the change in Nottingham Extended Activities of Daily Living (NEADL) score from baseline to three months.
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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To measure the change in Activities of Daily Living from Baseline and 2 months
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chercheur principal: Mackenzi Pergolotti, PhD, Colorado State University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 juin 2014
Achèvement primaire (Réel)
1 mars 2017
Achèvement de l'étude (Réel)
1 mars 2017
Dates d'inscription aux études
Première soumission
1 décembre 2014
Première soumission répondant aux critères de contrôle qualité
2 décembre 2014
Première publication (Estimation)
3 décembre 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
12 septembre 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 septembre 2017
Dernière vérification
1 septembre 2017
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- LCCC1409
- 14-1159 (Autre identifiant: University of North Carolina IRB)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Occupational and Physical Therapy
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