- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02613364
Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy in Reducing Insomnia in Cancer Survivors (YOCAS-II)
A Randomized Clinical Trial Comparing the Effectiveness of Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy for Treating Insomnia in Cancer Survivors
Aperçu de l'étude
Statut
Les conditions
Description détaillée
PRIMARY OBJECTIVES:
I. To determine if Yoga for Cancer Survivors (YOCAS) is effective for improving patient-reported insomnia (Insomnia Severity Index) compared to Cognitive Behavioral Therapy for Insomnia (CBT-I) and a health education control immediately post intervention.
SECONDARY OBJECTIVES:
I. To examine if YOCAS is effective for improving objective symptoms of insomnia (sleep latency, sleep efficiency, wake after sleep onset, sleep duration, and daytime napping via actigraphy) and global sleep quality impairment (Pittsburgh Sleep Quality Index) compared to CBT-I and a health education control.
II. To examine if YOCAS and CBT-I are effective for maintaining improvements in insomnia (Insomnia Severity Index) 3 and 6 months post intervention compared to a health education control.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients undergo the YOCAS intervention comprising 18 specific physical postures and mindfulness exercises focused on breathing and meditation and meet with the yoga instructor over 75 minutes 2 times a week for 4 weeks.
ARM II: Patients undergo CBT-I intervention comprising sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relapse prevention delivered by a health professional over 90 minutes once a week for 8 weeks.
ARM III: Patients attend survivorship health education sessions over 75 minutes 2 times a week for 4 weeks based on the American Society of Clinical Oncology cancer survivorship educational recommendations delivered by a community health educator. Patients also receive a booklet entitled, "Cancer Survivorship Next Steps for Patients and Their Families."
After completion of intervention, patients are followed up at 3 and 6 months.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Hawaii
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Honolulu, Hawaii, États-Unis, 96813
- Hawaii MU NCORP
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Illinois
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Decatur, Illinois, États-Unis, 62526
- Heartland NCORP
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Kansas
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Wichita, Kansas, États-Unis, 67214
- Wichita NCORP
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Louisiana
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New Orleans, Louisiana, États-Unis, 70112
- Gulf South MU-NCORP
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Michigan
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Ann Arbor, Michigan, États-Unis, 48106
- Michigan Cancer Research Consortium NCORP
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Grand Rapids, Michigan, États-Unis, 49503
- Cancer Research Consortium of West Michigan
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55426
- Metro-Minnesota NCORP
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Nevada
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Las Vegas, Nevada, États-Unis, 89106
- Nevada Cancer Research Foundation NCORP
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New York
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Rochester, New York, États-Unis, 14642
- University of Rochester NCORP Research Base
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North Carolina
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Winston-Salem, North Carolina, États-Unis, 27104
- Southeast Clinical Oncology Research Consortium
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Ohio
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Columbus, Ohio, États-Unis, 43215
- Columbus NCORP
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Dayton, Ohio, États-Unis, 45420
- Dayton Clinical Oncology Program
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Oregon
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Portland, Oregon, États-Unis, 97213
- Pacific Cancer Research Consortium Ncorp
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South Carolina
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Greenville, South Carolina, États-Unis, 29605
- Greenville Health System NCORP
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Wisconsin
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Marshfield, Wisconsin, États-Unis, 54449
- Wisconsin NCORP
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Milwaukee, Wisconsin, États-Unis, 53226
- Aurora NCORP
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Have a confirmed diagnosis of cancer
- Have received surgery, chemotherapy, and/or radiation therapy
- Have completed all surgery, chemotherapy and/or radiation therapy within the last 2-60 months
- Meet Diagnostic and Statistical Manual of Mental Disorders (DSM)-V criteria for insomnia and score >= 10 on the Insomnia Severity Index
- Be able to read and understand English
- Be able to provide written informed consent
Exclusion Criteria:
- Have contraindications to functional testing or yoga participation according to the treating physician
- Have practiced yoga >= 1 day a week within the 3 months prior to enrolling in the study
- Be planning to start yoga on their own during the time they are enrolled in the study
- Have a confirmed diagnosis of sleep apnea or restless leg syndrome
- Be receiving any form of treatment for cancer with the exception of hormonal or biologic therapy
- Have distant metastases
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Arm I (behavioral intervention-yoga)
Patients undergo the YOCAS intervention comprising 18 specific physical postures and mindfulness exercises focused on breathing and meditation and meet with the yoga instructor over 75 minutes 2 times a week for 4 weeks.
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Études corrélatives
Etudes annexes
Autres noms:
Undergo yoga intervention
Autres noms:
Correlative studies
Autres noms:
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Expérimental: Arm II (cognitive intervention-CBT-I)
Patients undergo CBT-I intervention comprising sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relapse prevention delivered by a health professional over 90 minutes once a week for 8 weeks.
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Études corrélatives
Etudes annexes
Autres noms:
Correlative studies
Autres noms:
Undergo CBT-I intervention
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Comparateur actif: Arm III (educational intervention)
Patients attend survivorship health education sessions over 75 minutes 2 times a week for 4 weeks based on the American Society of Clinical Oncology cancer survivorship educational recommendations delivered by a community health educator.
Patients also receive a booklet entitled, "Cancer Survivorship Next Steps for Patients and Their Families."
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Études corrélatives
Etudes annexes
Autres noms:
Recevoir une éducation à la santé
Autres noms:
Correlative studies
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Mean Change in the ISI Comparing YOCAS vs. CBT-I
Délai: Baseline up to post intervention (approximately 4 to 8 weeks)
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The Insomnia Severity Index is a validated measure of insomnia.
A 5-point Likert scale of 7 questions is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia.
Means and 95% confidence intervals for YOCAS and CBT-I will be calculated and plotted and examined in comparison with the a priori specified non-inferiority margin of 1.15.
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Baseline up to post intervention (approximately 4 to 8 weeks)
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Mean Change in the ISI Comparing YOCAS vs. Health Education
Délai: Baseline up to post intervention (approximately 4 to 8 weeks)
|
The Insomnia Severity Index is a validated measure of insomnia.
A 5-point Likert scale of 7 questions is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia.
A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education.
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Baseline up to post intervention (approximately 4 to 8 weeks)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Mean Change in Global Sleep Quality Impairment as Measured by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score Comparing YOCAS vs. Health Education
Délai: Baseline up to post intervention (approximately 4 to 8 weeks)
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The PSQI measures sleep quality with a total score ranging from 0-21 with higher scores indicating worse sleep quality.
A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education.
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Baseline up to post intervention (approximately 4 to 8 weeks)
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Mean Change in Global Sleep Quality Impairment as Measured by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score Comparing YOCAS vs. CBT-I.
Délai: Baseline up to post intervention (approximately 4 to 8 weeks)
|
The PSQI measures sleep quality with a total score ranging from 0-21 with higher scores indicating worse sleep quality.
A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I.
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Baseline up to post intervention (approximately 4 to 8 weeks)
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Mean Change in Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy Comparing YOCAS vs. Health Education
Délai: Baseline up to post intervention (approximately 4 to 8 weeks)
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Actigraphy will measure the number of minutes of actual sleep.
A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education.
|
Baseline up to post intervention (approximately 4 to 8 weeks)
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Mean Change in Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy Comparing YOCAS vs. CBT-I
Délai: Baseline up to post intervention (approximately 4 to 8 weeks)
|
Actigraphy will measure the number of minutes of actual sleep.
A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I.
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Baseline up to post intervention (approximately 4 to 8 weeks)
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Mean Change in Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy Comparing YOCAS vs. Health Education
Délai: Baseline up to post intervention (approximately 4 to 8 weeks)
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Actigraphy will measure total minutes of wake time after sleep onset.
A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education.
The transformation of the log base 10 of the original measurement was used for the analysis.
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Baseline up to post intervention (approximately 4 to 8 weeks)
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Mean Change in Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy Comparing YOCAS vs. CBT-I
Délai: Baseline up to post intervention (approximately 4 to 8 weeks)
|
Actigraphy will measure total minutes of wake time after sleep onset.
A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I.
The transformation of log base 10 of the original measurement was used for the analysis.
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Baseline up to post intervention (approximately 4 to 8 weeks)
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Mean Change in Objective Symptoms of Insomnia- Sleep Efficiency Via Actigraphy Comparing YOCAS vs. Health Education
Délai: Baseline up to post intervention (approximately 4 to 8 weeks)
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Actigraphy will measure the percent of time actually slept compared to intended time sleeping.
A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education.
|
Baseline up to post intervention (approximately 4 to 8 weeks)
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Mean Change in Objective Symptoms of Insomnia- Sleep Efficiency Via Actigraphy Comparing YOCAS vs. CBT-I
Délai: Baseline up to post intervention (approximately 4 to 8 weeks)
|
Actigraphy will measure the percent of time actually slept compared to intended time sleeping.
A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I.
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Baseline up to post intervention (approximately 4 to 8 weeks)
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Mean Change in Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy Comparing YOCAS vs. Health Education
Délai: Baseline up to post intervention (approximately 4 to 8 weeks)
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Actigraphy will measure the minutes it takes for the participant to fall asleep.
A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education.
The transformation of log base 10 of the (measurement + 1) was used in the analysis.
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Baseline up to post intervention (approximately 4 to 8 weeks)
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Mean Change in Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy Comparing YOCAS vs. CBT-I
Délai: Baseline up to post intervention (approximately 4 to 8 weeks)
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Actigraphy will measure the minutes it takes for the participant to fall asleep.
A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I.
The transformation of the log base 10 of the (measure + 1) was used in the analysis.
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Baseline up to post intervention (approximately 4 to 8 weeks)
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Mean Change in the ISI Comparing YOCAS and Health Education (3 Month)
Délai: Baseline to 3 months
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The Insomnia Severity Index is a validated measure of insomnia.
A 5-point Likert scale of 7 questions is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia.
A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education.
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Baseline to 3 months
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Mean Change in the ISI Comparing YOCAS and CBT-I (3 Month)
Délai: Baseline to 3 months
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The Insomnia Severity Index is a validated measure of insomnia.
A 5-point Likert scale of 7 questions is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia.
A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I.
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Baseline to 3 months
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Mean Change in the ISI Comparing YOCAS and Health Education (6 Month)
Délai: Baseline to 6 months
|
The Insomnia Severity Index is a validated measure of insomnia.
A 5-point Likert scale of 7 questions is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia.
A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education.
|
Baseline to 6 months
|
Mean Change in the ISI Comparing YOCAS and CBT-I (6 Month)
Délai: Baseline to 6 months
|
The Insomnia Severity Index is a validated measure of insomnia.
A 5-point Likert scale of 7 questions is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia.
A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I.
|
Baseline to 6 months
|
Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Karen Mustian, University of Rochester NCORP Research Base
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 (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
- URCC14040 (Autre identifiant: University of Rochester NCORP Research Base)
- UG1CA189961 (Subvention/contrat des NIH des États-Unis)
- NCI-2015-01144 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
- RSRB052271 (Autre identifiant: University of Rochester)
- URCC-14040 (Autre identifiant: CTEP)
- R01CA181064 (Subvention/contrat des NIH des États-Unis)
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