Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy in Reducing Insomnia in Cancer Survivors (YOCAS-II)

27. Februar 2021 aktualisiert von: Karen Mustian, University of Rochester NCORP Research Base

A Randomized Clinical Trial Comparing the Effectiveness of Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy for Treating Insomnia in Cancer Survivors

This randomized phase III trial compares yoga, survivorship health education program, and cognitive behavioral therapy in reducing sleep disturbance (insomnia) in cancer survivors. Insomnia can be described as excessive daytime napping, difficulty falling asleep, difficulty staying asleep, or waking up earlier than desired. Insomnia can increase fatigue, impair physical function, impair immune function, cause circadian rhythms (known as the biological clock) to be disrupted and decrease quality of life. Yoga may improve circadian rhythms, physical and immune function, and improve insomnia and sleep quality in cancer survivors. It is not yet known whether yoga is more effective at treating insomnia than a health education program or cognitive behavioral therapy program.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

746

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Hawaii
      • Honolulu, Hawaii, Vereinigte Staaten, 96813
        • Hawaii MU NCORP
    • Illinois
      • Decatur, Illinois, Vereinigte Staaten, 62526
        • Heartland NCORP
    • Kansas
      • Wichita, Kansas, Vereinigte Staaten, 67214
        • Wichita NCORP
    • Louisiana
      • New Orleans, Louisiana, Vereinigte Staaten, 70112
        • Gulf South MU-NCORP
    • Michigan
      • Ann Arbor, Michigan, Vereinigte Staaten, 48106
        • Michigan Cancer Research Consortium NCORP
      • Grand Rapids, Michigan, Vereinigte Staaten, 49503
        • Cancer Research Consortium of West Michigan
    • Minnesota
      • Minneapolis, Minnesota, Vereinigte Staaten, 55426
        • Metro-Minnesota NCORP
    • Nevada
      • Las Vegas, Nevada, Vereinigte Staaten, 89106
        • Nevada Cancer Research Foundation NCORP
    • New York
      • Rochester, New York, Vereinigte Staaten, 14642
        • University of Rochester NCORP Research Base
    • North Carolina
      • Winston-Salem, North Carolina, Vereinigte Staaten, 27104
        • Southeast Clinical Oncology Research Consortium
    • Ohio
      • Columbus, Ohio, Vereinigte Staaten, 43215
        • Columbus NCORP
      • Dayton, Ohio, Vereinigte Staaten, 45420
        • Dayton Clinical Oncology Program
    • Oregon
      • Portland, Oregon, Vereinigte Staaten, 97213
        • Pacific Cancer Research Consortium Ncorp
    • South Carolina
      • Greenville, South Carolina, Vereinigte Staaten, 29605
        • Greenville Health System NCORP
    • Wisconsin
      • Marshfield, Wisconsin, Vereinigte Staaten, 54449
        • Wisconsin NCORP
      • Milwaukee, Wisconsin, Vereinigte Staaten, 53226
        • Aurora NCORP

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Sonstiges: Labor-Biomarker-Analyse
Korrelative Studien
Sonstiges: Bewertung der Lebensqualität
Nebenstudien
Andere Namen:
  • Bewertung der Lebensqualität
Verhalten: Behavioral Intervention
Undergo yoga intervention
Andere Namen:
  • Verhaltenskonditionierungstherapie
  • Verhaltensänderung
  • Verhaltens- oder Lebensstiländerungen
  • Verhaltenstherapie
  • Verhaltensinterventionen
  • Verhaltensbehandlung
  • Verhaltensbehandlungen
  • VERHALTENSTHERAPIE
Gerät: Monitoring Device
Correlative studies
Andere Namen:
  • Monitor
Experimental: 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.
Sonstiges: Labor-Biomarker-Analyse
Korrelative Studien
Sonstiges: Bewertung der Lebensqualität
Nebenstudien
Andere Namen:
  • Bewertung der Lebensqualität
Gerät: Monitoring Device
Correlative studies
Andere Namen:
  • Monitor
Sonstiges: Cognitive Intervention
Undergo CBT-I intervention
Aktiver Komparator: 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."
Sonstiges: Labor-Biomarker-Analyse
Korrelative Studien
Sonstiges: Bewertung der Lebensqualität
Nebenstudien
Andere Namen:
  • Bewertung der Lebensqualität
Sonstiges: Pädagogische Intervention
Erhalten Sie Gesundheitserziehung
Andere Namen:
  • Erziehung zum Eingreifen
  • Intervention durch Bildung
  • Intervention, pädagogisch
Gerät: Monitoring Device
Correlative studies
Andere Namen:
  • Monitor

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Mean Change in the ISI Comparing YOCAS vs. CBT-I
Zeitfenster: 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. 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.
Baseline up to post intervention (approximately 4 to 8 weeks)
Mean Change in the ISI Comparing YOCAS vs. Health Education
Zeitfenster: 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.
Baseline up to post intervention (approximately 4 to 8 weeks)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Mean Change in Global Sleep Quality Impairment as Measured by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score Comparing YOCAS vs. Health Education
Zeitfenster: 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 health education.
Baseline up to post intervention (approximately 4 to 8 weeks)
Mean Change in Global Sleep Quality Impairment as Measured by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score Comparing YOCAS vs. CBT-I.
Zeitfenster: 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.
Baseline up to post intervention (approximately 4 to 8 weeks)
Mean Change in Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy Comparing YOCAS vs. Health Education
Zeitfenster: 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 health education.
Baseline up to post intervention (approximately 4 to 8 weeks)
Mean Change in Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy Comparing YOCAS vs. CBT-I
Zeitfenster: 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.
Baseline up to post intervention (approximately 4 to 8 weeks)
Mean Change in Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy Comparing YOCAS vs. Health Education
Zeitfenster: 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 health education. The transformation of the log base 10 of the original measurement was used for the analysis.
Baseline up to post intervention (approximately 4 to 8 weeks)
Mean Change in Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy Comparing YOCAS vs. CBT-I
Zeitfenster: 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.
Baseline up to post intervention (approximately 4 to 8 weeks)
Mean Change in Objective Symptoms of Insomnia- Sleep Efficiency Via Actigraphy Comparing YOCAS vs. Health Education
Zeitfenster: 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 health education.
Baseline up to post intervention (approximately 4 to 8 weeks)
Mean Change in Objective Symptoms of Insomnia- Sleep Efficiency Via Actigraphy Comparing YOCAS vs. CBT-I
Zeitfenster: 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.
Baseline up to post intervention (approximately 4 to 8 weeks)
Mean Change in Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy Comparing YOCAS vs. Health Education
Zeitfenster: Baseline up to post intervention (approximately 4 to 8 weeks)
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.
Baseline up to post intervention (approximately 4 to 8 weeks)
Mean Change in Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy Comparing YOCAS vs. CBT-I
Zeitfenster: Baseline up to post intervention (approximately 4 to 8 weeks)
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.
Baseline up to post intervention (approximately 4 to 8 weeks)
Mean Change in the ISI Comparing YOCAS and Health Education (3 Month)
Zeitfenster: Baseline to 3 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 3 months
Mean Change in the ISI Comparing YOCAS and CBT-I (3 Month)
Zeitfenster: Baseline to 3 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 3 months
Mean Change in the ISI Comparing YOCAS and Health Education (6 Month)
Zeitfenster: 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)
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Rochester NCORP Research Base

Mitarbeiter

National Cancer Institute (NCI)

Ermittler

  • Hauptermittler: Karen Mustian, University of Rochester NCORP Research Base

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

6. Mai 2016

Primärer Abschluss (Tatsächlich)

4. Februar 2020

Studienabschluss (Tatsächlich)

4. Februar 2020

Studienanmeldedaten

Zuerst eingereicht

20. November 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. November 2015

Zuerst gepostet (Schätzen)

24. November 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

23. März 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. Februar 2021

Zuletzt verifiziert

1. Februar 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • URCC14040 (Andere Kennung: University of Rochester NCORP Research Base)
  • UG1CA189961 (US NIH Stipendium/Vertrag)
  • NCI-2015-01144 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))
  • RSRB052271 (Andere Kennung: University of Rochester)
  • URCC-14040 (Andere Kennung: CTEP)
  • R01CA181064 (US NIH Stipendium/Vertrag)

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Labor-Biomarker-Analyse

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Panama

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

3
Abonnieren