- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01980368
Tai Chi Easy in Treating Cancer Survivors With Peripheral Sensory Neuropathy
Pilot Study of Effects of Tai Chi Easy on Cancer Survivors Experiencing Neuropathy
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
PRIMARY OBJECTIVES:
I. Examine effects of Tai Chi Easy (TCEasy) exercise intervention on peripheral sensory neuropathy of cancer survivors who have chemotherapy compared with an educational control (EC) intervention.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I (TAI CHI EASY): Patients attend Tai Chi Easy class for 60 minutes once a week for 6 weeks. Patients also receive a DVD and exercise manual of Tai Chi Easy exercises and are encouraged to practice at home for 30 minutes most days per week for 6 weeks.
GROUP II (EDUCATIONAL CONTROL): Patients receive readings each week and attend a book club to discuss the readings for 60 minutes once a week for 6 weeks.
After completion of study, patients are followed up at 2 months.
Type d'étude
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:
- 1 month - 5 years following completion of cytotoxic chemotherapy treatment for any cancer, and are experiencing neuropathy
- Self-report of >= 4 on the Peripheral Neuropathy Question
Exclusion Criteria:
- Recurrence of cancer or other active cancer
- Severe cachexia, dizziness, bone pain, or severe nausea (as judged by the investigator)
- Uncontrolled diabetes, untreated hypothyroidism
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Group I (Tai Chi Easy)
Patients attend Tai Chi Easy class for 60 minutes once a week for 6 weeks.
Patients also receive a DVD and exercise manual of Tai Chi Easy exercises and are encouraged to practice at home for 30 minutes most days per week for 6 weeks.
|
Etudes annexes
Receive Tai Chi Easy class, DVD, and exercise manual
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Comparateur actif: Group II (educational control)
Patients receive readings each week and attend a book club to discuss the readings for 60 minutes once a week for 6 weeks.
|
Etudes annexes
Receive readings and attend book club
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change in peripheral sensory neuropathy, assessed by Peripheral Neuropathy Question, European Organization for Research and Treatment of Cancer (EORTC)-30, EORTC-Chemotherapy-induced peripheral neuropathy-20, and the modified Total Neuropathy Score
Délai: Baseline up to 2 months
|
Will be assessed with a simple t-test of mTNS means.
Additional analyses of factors assessed will similarly be conducted (and overall analysis of variance when combining outcome variable assessment at the three time points, and models of factor contribution with logistic regression if appropriate).
|
Baseline up to 2 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Changes in anxiety assessed by POMS Total Mood Disturbance dimensions (tension-anxiety)
Délai: Baseline up to 2 months
|
Baseline up to 2 months
|
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Changes in body mass index assessed by weight and height
Délai: Baseline up to 2 months
|
Will be measured directly using standardized protocols with medical-quality calibrated balance scales.
|
Baseline up to 2 months
|
Changes in cognitive performance assessed by digit span and letter-number sequencing
Délai: Baseline up to 2 months
|
Baseline up to 2 months
|
|
Changes in depression assessed by Program Operations Manual System (POMS) Total Mood Disturbance dimensions (depression-dejection)
Délai: Baseline up to 2 months
|
Baseline up to 2 months
|
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Changes in fatigue assessed by Fatigue Symptom Inventory
Délai: Baseline up to 2 months
|
Baseline up to 2 months
|
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Changes in pain assessed by Medical Outcomes Study-Short Form 36
Délai: Baseline up to 2 months
|
Baseline up to 2 months
|
|
Changes in sleep quality assessed by Pittsburgh Sleep Quality Index and actigraph
Délai: Baseline up to 2 months
|
Baseline up to 2 months
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Donald Northfelt, Mayo Clinic
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 (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
Autres numéros d'identification d'étude
- 12-007483 (Autre identifiant: Mayo Clinic in Arizona)
- P30CA015083 (Subvention/contrat des NIH des États-Unis)
- NCI-2016-01373 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
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