Evaluating the Effects of Psycho-oncological Education on Distress and Quality of Life in Solid Tumor Cancer Patients
Evaluating the Effects of Psycho-oncological Education on Distress and Quality of Life in Solid Tumor Patients Who Have Received and Completed Chemotherapy Treatment With Curative Intent. A Pilot Study.
Aperçu de l'étude
Description détaillée
Solid tumor cancer patients who have completed chemotherapy with curative intent experience psychological distress. As a result these patients experience poorer quality of life (QOL), emotional vulnerability and unnecessary emotional suffering.
Purpose: To determine whether the implementation of a nurse driven psycho-oncological educational session will decrease psychological distress levels and improve QOL among solid tumor cancer patients who have received and completed chemotherapy with curative intent.
Methods: A randomized clinical trial (RCT) consisting of 28 eligible patients at Sibley Memorial Hospital will be used to compare the effect of psycho-oncological education to treatment as usual in reducing psychological distress and improving quality of life. The intervention group will receive one 60 minute session of psycho-oncological education. The comparison group will receive usual care only which includes a general information session offered prior to any treatment which addresses broad side-effects of treatment, an overview of the treatment process and identification of additional resources. Participants will be assessed for psychological distress and QOL levels at baseline and two weeks after the intervention.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- non-race specific
- solid tumor cancer patient
- completed chemotherapy with curative intent
Exclusion Criteria:
- diagnosis of cancer prior to cancer they are being treated for
- distress score of 8 or greater
- diagnosed with a psychiatric disorder
- diagnosed with lymphoma or leukemia
- in need of immediate crisis support
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Psycho-oncological education
One 60 minute psycho-oncological education session on late effects, fatigue and stress management.
|
One 60 minute psycho-oncological educational session on stress management, late effects and fatigue.
|
|
Aucune intervention: Usual Care
Usual care includes completion of a symptom checklist by the nurse practitioner
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Distress Thermometer (self-reported distress levels by 11 point scale) Change is being assessed
Délai: at baseline & two weeks after intervention
|
Self reported distress levels at baseline and two weeks after the intervention.
Scale is 11-points from 0(no distress) to 10 (extreme distress)
|
at baseline & two weeks after intervention
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
World Health Organization Quality of Life BREF (WHOQOL-BREF) Change is being assessed.
Délai: at baseline & two weeks after intervention
|
Self- report, 24 question scale representing 6 domains related to quality of life.
Quality of life to be measured at baseline and two weeks post intervention.
|
at baseline & two weeks after intervention
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Channing Paller, MD, Johns Hopkins University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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 (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
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
- SIB14142
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 .