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

27 lutego 2021 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

746

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Inny: Laboratoryjna analiza biomarkerów
Badania korelacyjne
Inny: Ocena jakości życia
Badania pomocnicze
Inne nazwy:
  • Ocena jakości życia
Behawioralne: Behavioral Intervention
Undergo yoga intervention
Inne nazwy:
  • Terapia warunkowania zachowania
  • Zmiana zachowania
  • Modyfikacje zachowania lub stylu życia
  • Terapia behawioralna
  • Interwencje behawioralne
  • Modyfikacja behawioralna
  • Leczenie behawioralne
  • TERAPIA BEHAWIORALNA
Urządzenie: Monitoring Device
Correlative studies
Inne nazwy:
  • Monitor
Eksperymentalny: 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.
Inny: Laboratoryjna analiza biomarkerów
Badania korelacyjne
Inny: Ocena jakości życia
Badania pomocnicze
Inne nazwy:
  • Ocena jakości życia
Urządzenie: Monitoring Device
Correlative studies
Inne nazwy:
  • Monitor
Inny: Cognitive Intervention
Undergo CBT-I intervention
Aktywny 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."
Inny: Laboratoryjna analiza biomarkerów
Badania korelacyjne
Inny: Ocena jakości życia
Badania pomocnicze
Inne nazwy:
  • Ocena jakości życia
Inny: Interwencja edukacyjna
Otrzymaj edukację zdrowotną
Inne nazwy:
  • Edukacja dla Interwencji
  • Interwencja przez edukację
  • Interwencja poprzez edukację
  • Interwencja, Edukacyjny
Urządzenie: Monitoring Device
Correlative studies
Inne nazwy:
  • Monitor

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Mean Change in the ISI Comparing YOCAS vs. CBT-I
Ramy czasowe: 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
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Mean Change in Global Sleep Quality Impairment as Measured by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score Comparing YOCAS vs. Health Education
Ramy czasowe: 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.
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Rochester NCORP Research Base

Współpracownicy

National Cancer Institute (NCI)

Śledczy

  • Główny śledczy: Karen Mustian, University of Rochester NCORP Research Base

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

6 maja 2016

Zakończenie podstawowe (Rzeczywisty)

4 lutego 2020

Ukończenie studiów (Rzeczywisty)

4 lutego 2020

Daty rejestracji na studia

Pierwszy przesłany

20 listopada 2015

Pierwszy przesłany, który spełnia kryteria kontroli jakości

23 listopada 2015

Pierwszy wysłany (Oszacować)

24 listopada 2015

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

23 marca 2021

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

27 lutego 2021

Ostatnia weryfikacja

1 lutego 2021

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • URCC14040 (Inny identyfikator: University of Rochester NCORP Research Base)
  • UG1CA189961 (Grant/umowa NIH USA)
  • NCI-2015-01144 (Identyfikator rejestru: CTRP (Clinical Trial Reporting Program))
  • RSRB052271 (Inny identyfikator: University of Rochester)
  • URCC-14040 (Inny identyfikator: CTEP)
  • R01CA181064 (Grant/umowa NIH USA)

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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