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

27 febbraio 2021 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

746

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altro: Analisi dei biomarcatori di laboratorio
Studi correlati
Altro: Valutazione della qualità della vita
Studi accessori
Altri nomi:
  • Valutazione della qualità della vita
Comportamentale: Behavioral Intervention
Undergo yoga intervention
Altri nomi:
  • Terapia del condizionamento comportamentale
  • Modifica del comportamento
  • Modifiche del comportamento o dello stile di vita
  • Terapia comportamentale
  • Interventi comportamentali
  • Modifica comportamentale
  • Trattamento comportamentale
  • Trattamenti comportamentali
  • TERAPIA COMPORTAMENTALE
Dispositivo: Monitoring Device
Correlative studies
Altri nomi:
  • Tenere sotto controllo
Sperimentale: 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.
Altro: Analisi dei biomarcatori di laboratorio
Studi correlati
Altro: Valutazione della qualità della vita
Studi accessori
Altri nomi:
  • Valutazione della qualità della vita
Dispositivo: Monitoring Device
Correlative studies
Altri nomi:
  • Tenere sotto controllo
Altro: Cognitive Intervention
Undergo CBT-I intervention
Comparatore attivo: 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."
Altro: Analisi dei biomarcatori di laboratorio
Studi correlati
Altro: Valutazione della qualità della vita
Studi accessori
Altri nomi:
  • Valutazione della qualità della vita
Altro: Intervento Educativo
Ricevere educazione sanitaria
Altri nomi:
  • Educazione all'intervento
  • Intervento dell'Educazione
  • Intervenire attraverso l'educazione
  • Intervento, Educativo
Dispositivo: Monitoring Device
Correlative studies
Altri nomi:
  • Tenere sotto controllo

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Change in the ISI Comparing YOCAS vs. CBT-I
Lasso di tempo: 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
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Change in Global Sleep Quality Impairment as Measured by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score Comparing YOCAS vs. Health Education
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Rochester NCORP Research Base

Collaboratori

National Cancer Institute (NCI)

Investigatori

  • Investigatore principale: Karen Mustian, University of Rochester NCORP Research Base

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

6 maggio 2016

Completamento primario (Effettivo)

4 febbraio 2020

Completamento dello studio (Effettivo)

4 febbraio 2020

Date di iscrizione allo studio

Primo inviato

20 novembre 2015

Primo inviato che soddisfa i criteri di controllo qualità

23 novembre 2015

Primo Inserito (Stima)

24 novembre 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

23 marzo 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 febbraio 2021

Ultimo verificato

1 febbraio 2021

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • URCC14040 (Altro identificatore: University of Rochester NCORP Research Base)
  • UG1CA189961 (Sovvenzione/contratto NIH degli Stati Uniti)
  • NCI-2015-01144 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
  • RSRB052271 (Altro identificatore: University of Rochester)
  • URCC-14040 (Altro identificatore: CTEP)
  • R01CA181064 (Sovvenzione/contratto NIH degli Stati Uniti)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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