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Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy

16 december 2016 bijgewerkt door: Joseph Roscoe, University of Rochester
This is a four-arm, randomized, controlled, clinical trial examining the efficacy of of cognitive behavioral therapy (CBT)-I and armodafinil in reducing insomnia in 226 female breast cancer patients who report sleep disturbances following completion of chemotherapy.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Treatment Protocol: CBT-I and armodafinil are being studied in a four-arm, randomized, controlled, clinical trial of 226 cancer survivors with chronic insomnia who are at least one month post treatment. The seven-week intervention is designed to determine the efficacy and acceptability of these treatment strategies in reducing insomnia in cancer survivors. Assessments will be made by questionnaires before, during, and two weeks following the study intervention. All ancillary treatments, as appropriate for control of symptoms caused by the cancer or its treatment may be administered as clinically indicated.

Withdrawal of Sleep Medications: All participants, prior to beginning the baseline data collection phase of the study, must have withdrawn from all sleep medications, including: prescription, over-the-counter, CAM and herbal remedies for at least one week prior to beginning the study.

CBT-I (Arms 3 & 4): CBT-I will be provided on an individual basis to all patients in study Arms 3 & 4 by a licensed clinical psychologist trained in CBT-I by Dr. Perlis. Subjects in these two study arms will receive 7 weeks of CBT-I, using a structured research grade protocol developed at the UR-SNRL. This manualized intervention, which exists as a published text: Perlis et al., 2005, includes four essential components: Sleep Restriction Therapy, Stimulus Control Instruction, Sleep Hygiene Guidelines, and a session of cognitive therapy.

Data Collection: Patients will complete the Insomnia Severity (ISI) at the time of consent and every Friday during weeks 3-11 of the study. A follow-up call by study personnel will be made to each participant not currently receiving CBT-I on each of these Fridays to promote compliance, prompt completion, assess potential side effects of study medication, and answer patient questions.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

138

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • New York
      • Rochester, New York, Verenigde Staten, 14642
        • University of Rochester James P. Wilmot Cancer Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Verenigde Staten, 19104
        • Behavioral Sleep Medicine Program, Department of Psychiatry, University of Pennsylvania

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

21 jaar tot 75 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. Have a diagnosis of cancer.
  2. Be able to understand written and spoken English
  3. Be able to swallow medication
  4. Have preferred sleep phase between 7:30 pm and 11:00 am
  5. Be willing to discontinue any medications/OTCs/Herbals for sleep for the 11-week study period
  6. Be presumed to be in a state of cancer remission; use of tamoxifen, an aromatase inhibitor, and/or Herceptin is permitted
  7. Self-report problems with insomnia for at least three months and that the insomnia began or got worse with the onset of cancer or treatment
  8. Have completed chemotherapy and or radiation not less than one month ago. Note: Both types of treatment must be completed at least one month ago if patient receives chemotherapy and radiation therapy and there is no outer limit to how long ago treatments were completed.)
  9. Report insomnia on the SDS-CL at a frequency of at least 3 days a week

Exclusion Criteria:

  1. Have ever taken modafinil or had CBT-I therapy. CBT-I therapy for the sake of this protocol will be defined as any cognitive behavioral-based treatment for insomnia that includes a sleep restriction component.
  2. Have an unstable medical or psychiatric illness (Axis I-current or within the last 5 years)
  3. Have a history of seizures or severe headaches, or uncontrolled cardiac disease or hypertension
  4. Be presently taking an anticoagulant or a corticosteroid
  5. Have taken amphetamines (e.g., methylphenidate, pemoline [Cylert®] or similar psycho stimulants) within the past 30 days
  6. Be currently pregnant or nursing
  7. Have a history of substance abuse, or meet criteria for current alcohol abuse or dependence as assessed by a CAGE test score >=2 or an Alcohol Use Disorders Identification Test (AUDIT) score >=13
  8. Have surgery planned within the study period
  9. Have have ever been diagnosed with sleep apnea or have sleep apnea as indicated by endorsing either question 11 (I wake up choking or gasping for air) or question 12 (My bed partner has noticed that I seem to stop breathing) on the Sleep Disorders Symptom Check at the "Often" or "Frequently" level.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 1 - CBT-I + placebo
CBT-I and placebo
Geneesmiddel: Placebo Comparator
Placebo for 47 days
Gedragsmatig: CBT-I
Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)
Experimenteel: 2 - CBT-I + Armodafinil
CBT-I + Armodafinil
Gedragsmatig: CBT-I
Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)
Geneesmiddel: armodafinil
Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
Placebo-vergelijker: 3 - Placebo only
Placebo only
Geneesmiddel: Placebo Comparator
Placebo for 47 days
Experimenteel: 4 - Armodafinil only
Armodafinil only
Geneesmiddel: armodafinil
Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Insomnia Severity Index From Baseline to Post-intervention
Tijdsspanne: ANCOVA was employed with multiple imputation on the post-intervention score (average of the two post-intervention weeks), controlling for the score at the time of consent (pre).
The Insomnia Severity Index (ISI) is a commonly used, 7-item psychometrically validated measure used to rate insomnia with 0-7 = absence of insomnia, 8-14 = subthreshold insomnia symptoms, 15-21 = moderate insomnia, and 22-28 = severe insomnia.
ANCOVA was employed with multiple imputation on the post-intervention score (average of the two post-intervention weeks), controlling for the score at the time of consent (pre).

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Fatigue Will be Assessed by the Total Score of the Revised Brief Fatigue Inventory (BFI) .
Tijdsspanne: ANCOVA was employed with multiple imputation on the post-intervention score (average of the two post-intervention weeks), controlling for the score at the time of consent (pre).
The revised Brief Fatigue Inventory (BFI) is a 9-item, patient-report instrument with established reliability and validity. The BFI allows for the rapid assessment of fatigue level in cancer patients and identifies those patients with severe fatigue. Three items ask patients to rate their fatigue "now," and fatigue at its "worst" and "usual" for the last 24 hours. The 11-point scales are bounded by 0 = "no fatigue" and 10 = "fatigue as bad as you can imagine." Using the same type of scales, the remaining questions ask patients to rate how their fatigue interferes with several functional domains, including general activity, walking, mood, work, and relations with others. These scales are bounded by 0 = "does not interfere" and 10 = "interferes completely." A global fatigue score (ranging from 0-10) can be obtained by averaging all the items on the BFI.
ANCOVA was employed with multiple imputation on the post-intervention score (average of the two post-intervention weeks), controlling for the score at the time of consent (pre).

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Rochester

Medewerkers

National Cancer Institute (NCI)

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 februari 2008

Primaire voltooiing (Werkelijk)

1 april 2013

Studie voltooiing (Werkelijk)

1 april 2013

Studieregistratiedata

Eerst ingediend

9 december 2009

Eerst ingediend dat voldeed aan de QC-criteria

22 maart 2010

Eerst geplaatst (Schatting)

24 maart 2010

Updates van studierecords

Laatste update geplaatst (Schatting)

9 februari 2017

Laatste update ingediend die voldeed aan QC-criteria

16 december 2016

Laatst geverifieerd

1 december 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • UCCS07090
  • 1R01CA126968-01A1 (Subsidie/contract van de Amerikaanse NIH)

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