Chemotherapy and Mindfulness Relaxation: A Randomized Trial at M.D. Anderson Cancer Center and M.D. Anderson Community Clinical Oncology Program
MR Therapy
+ Questionnaires
+ Relaxing Music (RM) Therapy
Maladies du système digestif+8
+ Néoplasmes du système digestif
+ Maladie
Autre étude
Résumé
Date de début de l'étude : 1 juin 2004
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Primary * Compare the effect of mindfulness relaxation vs relaxing music vs standard symptom management education on conditioned and nonconditioned nausea and vomiting in patients with newly diagnosed solid tumors undergoing chemotherapy. Secondary * Compare mental health (anxiety, depression, and distress), quality of life (cancer-related symptoms, fatigue, sleep, and pain), and immune function in patients receiving these interventions. OUTLINE: This is a multicenter study comprising a pilot phase followed by a randomized phase. (Pilot phase completed as of 3/10/2012.) * Pilot phase: Patients undergo mindfulness relaxation (MR) therapy comprising listening to instructions on breathing techniques and other mind and body relaxation practices on compact disc for 30 minutes before and during each chemotherapy session AND at least once daily for the entire duration of chemotherapy treatment. (Pilot phase completed as of 3/10/2012.) * Randomized phase: Patients are randomized to 1 of 3 treatment arms. * Arm I: Patients undergo MR therapy as in the pilot phase. * Arm II: Patients listen to relaxing music (with no instructions on relaxation techniques) for 30 minutes before and during each chemotherapy session AND at least once daily for the entire duration of chemotherapy treatment. * Arm III: Patients receive standard symptom management education. In both phases, nausea and vomiting, mental health (anxiety, depression, and distress), and quality of life (cancer-related symptoms, fatigue, sleep, and pain) are assessed at baseline, periodically during treatment, and then at 3 months. Patients are followed annually for up to 5 years for survival. PROJECTED ACCRUAL: A total of 474 patients will be accrued for this study.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.474 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Autre
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: 1. are \>/= 18 years of age 2. are anticipated to undergo at least four cycles of chemotherapy treatment 3. have had no previous treatment with chemotherapy 4. have no evidence of distant metastatic disease 5. can read/speak in English or Spanish 6. have no known psychotic diagnosis 7. have an expected survival of at least 6 months Exclusion Criteria: 1. have a known psychotic diagnosis 2. will undergo an undefined number of chemotherapy regimens
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.3 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalGroupe II
ExpérimentalGroupe III
Comparateur actifObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 9 sites
CCOP - Michigan Cancer Research Consortium
Ann Arbor, United StatesCCOP - Grand Rapids
Grand Rapids, United StatesCCOP - Kalamazoo
Kalamazoo, United States