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

27. februar 2021 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

746

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: Laboratoriebiomarkøranalyse
Korrelative studier
Annen: Livskvalitetsvurdering
Hjelpestudier
Andre navn:
  • Livskvalitetsvurdering
Atferdsmessig: Behavioral Intervention
Undergo yoga intervention
Andre navn:
  • Atferdskondisjonerende terapi
  • Atferdsendring
  • Adferds- eller livsstilsendringer
  • Atferdsterapi
  • Atferdsmessige intervensjoner
  • Atferdsmessig behandling
  • Atferdsmessige behandlinger
Enhet: Monitoring Device
Correlative studies
Andre navn:
  • Observere
Eksperimentell: 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.
Annen: Laboratoriebiomarkøranalyse
Korrelative studier
Annen: Livskvalitetsvurdering
Hjelpestudier
Andre navn:
  • Livskvalitetsvurdering
Enhet: Monitoring Device
Correlative studies
Andre navn:
  • Observere
Annen: Cognitive Intervention
Undergo CBT-I intervention
Aktiv 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."
Annen: Laboratoriebiomarkøranalyse
Korrelative studier
Annen: Livskvalitetsvurdering
Hjelpestudier
Andre navn:
  • Livskvalitetsvurdering
Annen: Pedagogisk intervensjon
Få helseundervisning
Andre navn:
  • Utdanning for intervensjon
  • Intervensjon fra utdanning
  • Intervensjon gjennom utdanning
  • Intervensjon, pedagogisk
Enhet: Monitoring Device
Correlative studies
Andre navn:
  • Observere

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mean Change in the ISI Comparing YOCAS vs. CBT-I
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mean Change in Global Sleep Quality Impairment as Measured by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score Comparing YOCAS vs. Health Education
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Rochester NCORP Research Base

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

6. mai 2016

Primær fullføring (Faktiske)

4. februar 2020

Studiet fullført (Faktiske)

4. februar 2020

Datoer for studieregistrering

Først innsendt

20. november 2015

Først innsendt som oppfylte QC-kriteriene

23. november 2015

Først lagt ut (Anslag)

24. november 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. mars 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. februar 2021

Sist bekreftet

1. februar 2021

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • URCC14040 (Annen identifikator: University of Rochester NCORP Research Base)
  • UG1CA189961 (U.S. NIH-stipend/kontrakt)
  • NCI-2015-01144 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
  • RSRB052271 (Annen identifikator: University of Rochester)
  • URCC-14040 (Annen identifikator: CTEP)
  • R01CA181064 (U.S. NIH-stipend/kontrakt)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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