Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Yoga for Fatigue in the Survivors of Bone Marrow Transplantation

8 août 2018 mis à jour par: Mohamad Baydoun, University of Michigan

Yoga for Persistent Fatigue in the Survivors of Bone Marrow Transplantation: A Feasibility Study

Cancer-related fatigue (CRF) after hematopoietic cell transplantation (HCT) is a persistent problem that limits activities and causes distress. Considering the high prevalence of CRF among HCT survivors and the limitations of currently existing treatments, there is a pressing need for establishing safe and effective options for reducing CRF after HCT. Based on evidence supporting the use of yoga for CRF in non-HCT populations, yoga is one option worthy of evaluation for ameliorating CRF in HCT patients. Yoga is easy to implement, may be appealing to HCT patients, and can be self-administered, which would encourage long-term use and potentially lead to a better control of persistent CRF in HCT survivors. The primary aim of the proposed study is to assess the feasibility of a yoga intervention for HCT survivors with CRF. Outcomes from this feasibility study will provide the information needed to design a larger, adequately powered randomized controlled trial to evaluate yoga for CRF in HCT survivors. This study will employ a mixed-methods, single-arm, pretest-posttest design with focus groups. Twenty HCT survivors who report at least moderate fatigue will be recruited from the HCT clinic, Michigan Medicine. Participants will be enrolled in a six-week Restorative yoga program. The program will consist of a weekly, 60-minute yoga group class led by a certified yoga instructor along with twice-weekly home practice using yoga DVD.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

OBJECTIVES

Primary Objective: To assess the feasibility of an organized yoga intervention for HCT survivors with CRF.

Hypothesis: A trial of yoga in the HCT survivor population will be deemed feasible if at least 75% of study subjects demonstrated protocol adherence rate of at least 80%.

Secondary Objectives:

- Explore participants' perceptions regarding yoga and physical activity

Hypothesis: HCT survivors will be positive about yoga and will express satisfaction with the yoga program, as will be shown during focus groups that will be held at the end of the yoga program.

- Evaluate the association between yoga practice and self-efficacy and self-regulation

Hypothesis: Adherence to yoga will be associated with higher self-efficacy and selfregulation scores.

- Evaluate the changes in CRF scores from baseline to the end of the yoga program.

Hypothesis: CRF scores at the end of the yoga program will be lower than CRF scores at baseline.

- Evaluate whether changes in CRF are associated with changes in depression, sleep disturbances, physical activity, and pain.

Hypothesis 5: Improvement in CRF will be associated with increased physical activity and decreased depression, sleep disturbances, and pain.

- Evaluate the safety of yoga practice in HCT survivors.

Hypothesis: Yoga will be considered as a safe intervention for CRF in HCT survivors as demonstrated by the absence of adverse events or serious adverse events related to or associated with yoga practice.

Type d'étude

Interventionnel

Inscription (Réel)

20

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Michigan
      • Ann Arbor, Michigan, États-Unis, 48105
        • Cancer center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Adult HCT survivors as defined by being at least 100 days post autologous or allogeneic transplantation for a malignant disease. There is no restriction to enrollment by donor type, donor cell source, presence or absence of graft versus host disease.
  • Age ≥ 18 years at the time of transplant.
  • A history of persistent CRF as defined by a perception of general CRF for at least one month before enrollment.
  • A history of at least moderate CRF as defined by a CRF score of 4 or more on a 10-point Visual Analog Scale.
  • Participants who are deemed qualified for yoga movements according to the Yoga Qualifying Movements Screening Checklist (a checklist developed by researchers at the University of California, Los Angeles to promote yoga safety through assessing the eligibility of each patient)

Exclusion Criteria:

  • A self-reported current practice of yoga or any other mind-body therapy, including but not limited to meditation or hypnosis therapy in the past 30 days prior to study enrollment.
  • Subjects currently on supplemental oxygen support.
  • Subjects currently receiving hemodialysis.
  • Subjects currently admitted to an inpatient unit at Michigan Medicine.
  • Subjects with an uncontrolled, active infection. Subjects with viremia (Cytomegalovirus or other) may be enrolled, provided they are on active therapy and at the discretion of the treating physician.
  • Subjects who have relapsed after their autologous or allogeneic transplant.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Yoga arm
A six-week restorative yoga intervention consisting of a weekly, 60-minute yoga group class led by a certified yoga instructor along with twice-weekly home practice using yoga DVD.
Comportemental: Yoga
This is a single arm study and all participants will be assigned to a six-week restorative yoga intervention. Restorative yoga sessions will consist of gentle physical poses (asanas), breathing control (pranayama), and relaxation (savasana).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Practice log
Délai: Weekly during the six-week intervention period
Yoga practice at home will be documented on a log sheet to be filled out by participants at the end of each practice week. We will check class attendance during the weekly telephone call with the study participants. We will use a log sheet to document in-class yoga practice and location of the yoga performance. At the end of the program, the number of yoga practice hours per participant will be tabulated. This number will be used to evaluate participants' adherence to yoga practice.
Weekly during the six-week intervention period

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Side-effects/adverse events log
Délai: Weekly during the six-week intervention period
All subjects will be asked to complete a Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) weekly. The PRO-CTCAE questionnaire in this study includes a total of six items (numbness and tingling, dizziness, blurry vision, muscle pain, joint pain, others).
Weekly during the six-week intervention period
Multidimensional Fatigue Symptom Inventory
Délai: At baseline (before treatment) and within 10 days of the last in-class yoga session
The Multidimensional Fatigue Symptom Inventory-Short Form (MFSISF) will be used to measure fatigue in the past seven days. The MFSISF includes a total of 30 items that produce five subscales: general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigor. All items have a possible score of 0 to 4, 0 representing "not at all" and 4 being "extremely".
At baseline (before treatment) and within 10 days of the last in-class yoga session
PROMIS-SF-Fatigue
Délai: At baseline (before treatment) and within 10 days of the last in-class yoga session
The PROMIS-SF-Fatigue will be used to measure fatigue in the past seven days. The PROMIS-SF-fatigue is a unidimensional scale that measures general fatigue. It contains eight items with a possible score of 1 to 5 for each item.
At baseline (before treatment) and within 10 days of the last in-class yoga session
Brief Pain Inventory - Short Form
Délai: At baseline (before treatment) and within 10 days of the last in-class yoga session
The Brief Pain Inventory - Short Form (BPISF) will be used to measure pain in the past 24 hours. The BPISF is a 9-item questionnaire used to evaluate the severity of a participants' pain and the impact of pain on the patient's daily functioning.
At baseline (before treatment) and within 10 days of the last in-class yoga session
PROMIS-SF-depression
Délai: At baseline (before treatment) and within 10 days of the last in-class yoga session
The PROMIS-SF-depression will be used to measure depression in the past seven days. The PROMIS-SF-depression contains eight items with a possible score of 1 to 5 for each item (1: never, 5: always).
At baseline (before treatment) and within 10 days of the last in-class yoga session
PROMIS-SF-sleep disturbance
Délai: At baseline (before treatment) and within 10 days of the last in-class yoga session
The PROMIS-SF-sleep disturbance will be used to measure sleep disturbance in the past seven days. The PROMIS-SF-sleep disturbance contains eight items with a possible score of 1 to 5 for each item.
At baseline (before treatment) and within 10 days of the last in-class yoga session
Index of Self-Regulation Scale
Délai: At baseline (before treatment) and within 10 days of the last in-class yoga session
The Index of Self-Regulation Scale (ISR) is designed to measure individuals' level of self-regulation for health behaviors. The ISR contains nine items that produces three subscales: reconditioning, stimulus control, and behavioral monitoring.
At baseline (before treatment) and within 10 days of the last in-class yoga session
Self-Efficacy for Managing Chronic Disease Scale
Délai: At baseline (before treatment) and within 10 days of the last in-class yoga session
Self-efficacy will be measured using the Self-Efficacy for Managing Chronic Disease Scale (SEMCD). The SEMCD contains six items. Each item has a possible score of 1 to 10 (1: not at all confident, 10: totally confident).
At baseline (before treatment) and within 10 days of the last in-class yoga session
PROMIS-SF- physical function
Délai: At baseline (before treatment) and within 10 days of the last in-class yoga session
The PROMIS-SF- physical function contains 12 items with a possible score of 1 to 5 for each item (1: unable to do, 5: without any difficulty). All items are reversely coded. The total score can range from 12 to 60 with higher scores indicating better physical function.
At baseline (before treatment) and within 10 days of the last in-class yoga session
electronic pedometer
Délai: At baseline (before treatment) and within 10 days of the last in-class yoga session
The electronic pedometer is an objective measure of physical activity. It is a simple, unobtrusive device that can be placed on the belt or waistband to count the number of steps taken.
At baseline (before treatment) and within 10 days of the last in-class yoga session

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Michigan

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

22 décembre 2017

Achèvement primaire (Réel)

31 juillet 2018

Achèvement de l'étude (Réel)

31 juillet 2018

Dates d'inscription aux études

Première soumission

27 septembre 2017

Première soumission répondant aux critères de contrôle qualité

27 septembre 2017

Première publication (Réel)

3 octobre 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 août 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

8 août 2018

Dernière vérification

1 août 2018

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • HUM00130548

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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 .

Essais cliniques sur Yoga

Rechercher des essais similaires

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

CROs by country

CROs in Malaysia

Conditions

Maladies rares

Interventions en matière de drogue

Compléments alimentaires

Commanditaire / collaborateurs

Emplacements

S'abonner