- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03642093
HOPE - A Study to Evaluate the Effect of a Prehabilitation Program on GI Cancer Patients Planning to Undergo Surgery (HOPE)
H.O.P.E. Healing Optimization Through Preoperative Engagement: A Prospective Single Cohort Study to Evaluate the Effect of a Prehabilitation Program on Preoperative Outcomes in Upper GI Surgical Oncology Patients
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Cancer patients often develop protein calorie malnutrition, inflammatory states, and loss of lean muscle mass, which can be best categorized as frailty. Frailty affects global health, the ability to carry out normal functions, and even the ability to tolerate targeted curative treatments such as surgery, chemotherapy, and radiation. The Investigators evaluate frailty, and design a study to evaluate the outcomes of the administration of multimodal preoperative prehabilitation programs on those frailty markers. Previous data provides support for interventions that include:
- Improved protein rich nutrition with specific immunonutrition recommendations,
- Treatment of maldigestion or pancreatic insufficiency in pancreatic, gastric, or esophageal cancer patients,
- Brief, evidence-based activity interventions such as walking and inspiratory muscle training (IMT), and
- Disease specific education
These interventions should improve frailty by maintaining or regaining weight, improved grip strength, and improved prealbumin. These markers indicate improvements in nutritional status, increased strength and ability to ambulate, and improved functional status in the preoperative period. Other outcomes that will be reported include fat-soluble vitamin levels, global health, and inflammation.
The preoperative period is the best time to facilitate patient engagement through self-care and proactive activity. Interventions must be easy to accomplish and structured so patients have accountability and both patients and clinicians have methods and tools for measuring progress. Most patients and family members are motivated at this time and understand the need to improve frailty and potentially improve global health.
Type d'étude
Inscription (Anticipé)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
-
-
Louisiana
-
New Orleans, Louisiana, États-Unis, 70471
- Ochsner Medical Center
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- All patients must be patients of Ochsner being seen at the Ochsner Medical Center (OMC).
- All patients must be 25 to 80 years of age.
- All patients must have a diagnosis of cancer.
- > 10 pound unintentional weight loss within 1 year
- Ability to perform grip strength test and Timed Up and Go (TUG) test
- Willingness to participate in the study, document compliance, and attend clinical appointments
All patients must be undergoing one of the following major elective surgical oncologic resections with curative intent:
- Pancreaticoduodenectomy for pancreatic cancer
- Distal pancreatectomy / splenectomy for pancreatic cancer
- Esophageal robotic assisted laparoscopic thoracoscopic esophagectomy for esophageal cancer
- Laparoscopic or open, partial or total gastrectomy for gastric cancer
Exclusion Criteria:
- All patients not undergoing oncologic or major resections.
- All patients unwilling or unable to answer questionnaires or accept help to answer electronic or paper questionnaires.
- All patients that are unable to participate in an activity program.
- All patients unable to wear an electronic activity monitoring device.
- All patients not wanting to follow a specific nutritional and breathing intervention.
- All patients that are not able or wishing to consent.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Frail
Subjects assessed and determined to be Frail and meet trial eligibility criteria will be enrolled on Frail Arm and begin a 4 Week program consisting of Nutritional Interventions and Physical Activity Interventions
|
Nutritional Supplementation for all subjects and Pancreatic Enzyme Replacement Therapy only for subjects with Exocrine Pancreatic Insufficiency
Autres noms:
Walking and Inspiratory Muscle Training
|
|
Comparateur actif: Not Frail
Subjects assessed and determined to be Not Frail and meet trial eligibility criteria will be enrolled on Not Frail Arm and begin a 4 Week program consisting of Nutritional Interventions and Physical Activity Interventions
|
Nutritional Supplementation for all subjects and Pancreatic Enzyme Replacement Therapy only for subjects with Exocrine Pancreatic Insufficiency
Autres noms:
Walking and Inspiratory Muscle Training
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Frailty Measurement
Délai: 4 Weeks
|
Frailty will be measured using 3 criteria: weight loss, grip strength, and prealbumin serum level
|
4 Weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Vitamin levels
Délai: 4 Weeks
|
4 Weeks
|
|
|
Quality of Life (QoL) Assessment
Délai: 4 Weeks
|
QoL will be assessed using Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Questionnaire - PROMIS Scale v1.2 - Global Health
|
4 Weeks
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Siobhan M Trotter, DNP, Ochsner Health System
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- HOPE Study 2018.045
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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 .
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