Soins palliatifs intégrés dans la gestion des symptômes chez les participants atteints de malignités thoraciques récurrentes de stade III-IV et leurs soignants
Soins palliatifs intégrés dans la prise en charge des tumeurs malignes thoraciques avancées
This trial studies how well embedded palliative care works in managing symptoms in participants with stage III-IV thoracic malignancies that has come back and their caregivers. Embedded palliative care may improve distress and anxiety in participants and caregivers.
Aperçu de l'étude
Statut
Les conditions
- Cancer du poumon de stade IVA AJCC v8
- Cancer du poumon de stade IVB AJCC v8
- Carcinome pulmonaire récurrent
- Cancer du poumon de stade III AJCC v8
- Cancer du poumon de stade IV AJCC v8
- Cancer du poumon de stade IIIA AJCC v8
- Cancer du poumon de stade IIIB AJCC v8
- Cancer du poumon de stade IIIC AJCC v8
- Soignant
- Carcinome thymique métastatique
- Tumeur pleurale maligne
- Carcinome thymique récurrent
Intervention / Traitement
Description détaillée
PRIMARY OBJECTIVES:
I. To determine feasibility of embedding a palliative care (PC) physician within the James Thoracic Oncology Clinic.
II. To assess patient and caregiver outcomes over a 12-month period within an embedded onco-palliative care clinic model.
III. To evaluate and describe clinician attitudes and beliefs regarding utilization of embedded palliative care as well as symptoms of provider burnout.
IV. To analyze health care utilization among participants receiving embedded onco-palliative care.
OUTLINE:
Participants and caregivers undergo embedded palliative care comprising symptom management (physical and psychological), advanced directives and goals of care discussion, caregiver support, and referral for adjunctive supportive services as needed at each clinic visit.
After completion of study, patients are followed for up to 1 year.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Ohio
-
Columbus, Ohio, États-Unis, 43210
- Ohio State University Comprehensive Cancer Center
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patients with advanced or metastatic cancer of the chest (lung, thymus, or pleura): stage III or IV, recurrent disease
- Patients will receive therapy (chemotherapy, immunotherapy, targeted therapy or radiation therapy) at The Ohio State University
- New patients (defined as patients who have received no therapy for metastatic disease or have started treatment for metastatic disease within the last 30 days) or established patients with advanced cancer receiving anti-cancer therapy, no limit on prior therapies
- Patient and caregiver must be able to read and understand consent form
- Patients must designate a willing caregiver to participate although caregiver consent is not required for patient participation
Exclusion Criteria:
- Patients who are already enrolled or have been previously enrolled in palliative care or hospice services as an outpatient. Inpatient palliative care consultation prior to enrollment is permitted
- Patients who do not qualify for active anti-cancer therapy and opt to enroll in hospice services prior to study enrollment
- Patients who are unable to read or understand consent form
- Patients receiving primary systemic treatment outside of Ohio State. Outside radiation therapy is permitted
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Supportive care (embedded palliative care)
Participants and caregivers undergo embedded palliative care comprising symptom management (physical and psychological), advanced directives and goals of care discussion, caregiver support, and referral for adjunctive supportive services as needed at each clinic visit. |
Ancillary studies Undergo embedded palliative care
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Acceptance from providers to assess utilization of palliative care services
Délai: Up to 12 months
|
Acceptance will be evaluated utilizing provider surveys (to capture provider opinions on palliative care utilization) as well as rate of enrollment. Preliminary data will be summarized and collected. Confidence intervals will also be calculated for feasibility rates. |
Up to 12 months
|
|
Demand of palliative care services to be evaluated
Délai: Up to 12 months
|
Preliminary data will be summarized and collected. Confidence intervals will also be calculated for feasibility rates. |
Up to 12 months
|
|
Capacity and productivity to be evaluated
Délai: Up to 12 months
|
Clinician capacity and productivity will be evaluated by looking at scheduling as well as billing productivity. Preliminary data will be summarized and collected. Confidence intervals will also be calculated for feasibility rates. |
Up to 12 months
|
|
Resource assessment of staff and space
Délai: Up to 12 months
|
Resources required, including patient care rooms and nursing support will also be evaluated. Preliminary data will be summarized and collected. Confidence intervals will also be calculated for feasibility rates. |
Up to 12 months
|
|
Symptom burden (patient outcome) supportive care screen
Délai: Up to 12 months
|
Will be assessed using Supportive care screen. |
Up to 12 months
|
|
Symptom burden (patient outcome) Functional Assessment of Cancer Therapy-Lung
Délai: Up to 12 months
|
Will be assessed using Functional Assessment of Cancer Therapy-Lung |
Up to 12 months
|
|
Symptom burden (patient outcome) using HADS
Délai: Up to 12 months
|
Will be assessed using Hospital Anxiety and Depression Scale (HADS) |
Up to 12 months
|
|
Symptom burden using National Comprehensive Cancer Network distress thermometer (patient outcome)
Délai: Up to 12 months
|
Will be assessed using National Comprehensive Cancer Network distress thermometer |
Up to 12 months
|
|
Anxiety assessment using Hospital Anxiety and Depression Scale (patient outcome)
Délai: Up to 12 months
|
Anxiety assessed using the Hospital Anxiety and Depression Scale |
Up to 12 months
|
|
Depression assessment using Hospital Anxiety and Depression Scale (patient outcome)
Délai: Up to 12 months
|
Depression assessed using the Hospital Anxiety and Depression Scale |
Up to 12 months
|
|
Functional status assessed using Functional Activities Scale (patient outcome)
Délai: Up to 12 months
|
Functional status assessment using Functional Activities Scale (FAS) |
Up to 12 months
|
|
Health care service needs assessed using Supportive Care Needs Survey Partners and Caregivers (SCNS- P and C) (Caregiver outcome)
Délai: Up to 12 months
|
Caregiver needs assessment using Supportive Care Needs Survey - Patients & Caregivers (SCNC-P&C) |
Up to 12 months
|
|
Psychological/emotional needs assessed using SCNS- P and C (Caregiver outcome)
Délai: Up to 12 months
|
Caregiver needs assessment using Supportive Care Needs Survey - Patients & Caregivers (SCNC-P&C) |
Up to 12 months
|
|
Work/social needs assessed using SCNS- P and C (Caregiver outcome)
Délai: Up to 12 months
|
Caregiver needs assessment using Supportive Care Needs Survey - Patients & Caregivers (SCNC-P&C) |
Up to 12 months
|
|
Information needs assessed using SCNS- P and C (Caregiver outcome)
Délai: Up to 12 months
|
Caregiver needs assessment using Supportive Care Needs Survey - Patients & Caregivers (SCNC-P&C) |
Up to 12 months
|
|
Self-reported barriers and attitudes regarding palliative care assessed using Ohio State Palliative Care Provider Survey (Provider outcome)
Délai: Up to 12 months
|
Ohio State Palliative Care Provider survey used to assess perceived barriers to referral |
Up to 12 months
|
|
Health care utilization outcomes
Délai: Up to 12 months
|
Will be captured using Integrated Health Information Systems electronic medical record data as well as patient reported events. |
Up to 12 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Challenges for patients, caregivers, and the treating oncologist in an embedded palliative care model
Délai: Up to 12 months
|
evaluate the challenges for patients, caregivers and treating oncologist in embedded palliative care |
Up to 12 months
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Carolyn Presley, MD, Ohio State University Comprehensive Cancer Center
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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
Termes MeSH pertinents supplémentaires
- Tumeurs par site
- Tumeurs
- Maladies des voies respiratoires
- Tumeurs par type histologique
- Maladies pulmonaires
- Tumeurs des voies respiratoires
- Tumeurs thoraciques
- Maladies lymphatiques
- Tumeurs, complexes et mixtes
- Tumeurs du thymus
- Maladies hémiques et lymphatiques
- Tumeurs pulmonaires
- Thymome
- Thérapeutique
- Soins aux patients
- Services de santé
- Conseils de soins de santé
- Soins palliatifs
- Réconfort du patient
Autres numéros d'identification d'étude
- OSU-18116
- NCI-2018-01209 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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
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 .