Combinatietherapie voor de behandeling van slaapstoornissen bij patiënten met gevorderde kanker
To learn if Cognitive Behavior Therapy (called CBT), combined with either Bright Light Therapy (called BLT), methylphenidate, and/or melatonin, can help improve sleep and other related symptoms such as fatigue, anxiety, and depression in cancer patients. This is an investigational study. In this study, BLT, Methylphenidate and Melatonin will be compared to their placebos.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Objectives:
Primary:
To compare the effects of the combination therapy arm with the placebo arm on sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) at the end of 6 weeks (primary end point). We hypothesize that there will be a greater maintenance of sleep quality in the combination arm than in the placebo arm after 6 weeks.
Secondary:
To compare the effects of the combination therapy arm with the placebo arm on sleep quality (PSQI) at 3- and 6-months post-intervention. We hypothesize that there will be a greater maintenance of sleep quality in the combination arm than in the placebo arm at 3- and 6-months post intervention.
Secondary:
To compare the effects of the remaining active therapy arms with the placebo and combination arms on sleep quality (PSQI) at all post-intervention assessments. We hypothesize that there will be a greater maintenance of sleep quality in the active arms than in the placebo arm at all post-intervention assessments. Additionally, there will be greater maintenance of sleep quality in the combination arm than in the remaining active arms.
Secondary:
To compare the effects of the active therapy arm and the placebo arm for sleep-wake cycle disturbance (Actigraphy - sleep onset latency, wake after sleep onset, total sleep time, sleep efficiency, and mean daytime activity). We hypothesize that there w/ill be greater maintenance of sleep-wake cycle (synchronization) in the combination therapy arm.
Secondary:
To determine whether the addition of MP to BLT+MT synergistically maintains sleep quality as measured by change from baseline PSQI. We hypothesize that MP and BLT+MT will synergistically maintain sleep quality.
Exploratory:
To explore the effects of the active therapy arm on psychological symptoms (Hospital Anxiety and Depression Scale), fatigue (Functional Assessment of Chronic Illness Therapy - Fatigue), sleep and related symptoms (PROMIS-Sleep), inflammation (C-reactive protein), resting-state cognition (Amsterdam resting-state questionnaire, ARSQ) and quality of life (Functional Assessment of Cancer Therapy - General) and how they vary over time. We hypothesize that there will be more promotion of sleep related symptoms and quality of life in the combination therapy arm than in the placebo, BLT, and Methylphenidate arms.
Exploratory:
To explore changes in brain function and structure (using functional, structural and diffusion-weighted MRI) and changes in resting-state cognition (ARSQ) and sleep symptoms following (a) combination therapy arm (i.e., CBT + BLT + MP + MT); (b) CBT + BLT + MT + placebo (MP); (c) CBT + MP + placebo (control light + MT); and (d) CBT + placebo (control light + MT + MP). We hypothesize that in patients with advanced cancer and sleep disturbances, there will be changes in (a) resting-state brain connectivity within the default-mode network; (b) cortical volume within specific brain areas including bilateral thalamus; and (c) white-matter water diffusion in specific fibers tracts that underline directed functional connectivity, including connectivity between the pulvinar, agranular frontal area and the parietal cortex - following (a-d) therapy arms; and (e) improvements in brain function and structure will be the most robust in combination therapy arm than placebo arm. We further hypothesize that improvements in brain function and structure will be associated with improvements in resting-state cognition and depressive symptoms.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
- Fase 3
Contacten en locaties
Studie Locaties
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Texas
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Houston, Texas, Verenigde Staten, 77030
- MD Anderson Cancer Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- presence of poor sleep quality, defined as Pittsburgh Sleep Quality Index (PSQI) total score ≥ 5, with patients describing poor sleep as being present for a minimum of 2 weeks;
- ability to communicate in English;
- cognitively competent to respond appropriately to questions, as measured by the Memorial Delirium Assessment Scale (MDAS) (≤ 13/30);
- willing and able to sign a written informed consent;
- life expectancy of ≥ 1 year as assessed by the oncologist or the principal investigator (SY) using the "surprise question," "Would I be surprised if this patient died in the next 12 months?"; and
- no pain or stable pain (defined as pain ≤ 4 on Edmonton Symptom Assessment Scale (ESAS) or under control and on stable doses of opioids for 1 month).
- Age 18 years or older
- be willing to complete in-person or telemedicine follow-up visits with research staff, and able to complete CBT intervention either in person or virtually within Texas.
Exclusion Criteria:
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active use of systemic anti-inflammatory prescription medications including steroids; unless used during or prior to cancer treatment as a prophylaxis (i.e., nausea);
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known history of psychiatric illness (e.g., schizophrenia, bipolar disorder, major depressive disorder), sleep disorder (e.g., obstructive sleep apnea, narcolepsy, periodic limb movement disorder), obesity hypoventilation syndrome, glaucoma, congenital blindness, self-reported acquired blindness, significant cataracts or retinal disease; and night shift workers.
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Hospital Anxiety and Depression (HADS) score ≥21, or use of antidepressants, unless the patient is receiving a stable dose for at least 1 month;
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use of hypnosedative drugs or stimulants; unless on stable doses of hypnosedative drugs or stimulants for at least 1 month;
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use of monoamine oxidase inhibitors (MOI), tricyclic anti-depressants and anticoagulants; and
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patients who have bright sunlight exposure for consecutive 30 minutes or more daily in the past month, or prior exposure to BLT, or prior use of MT, MP, or CBT.
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other medical reason that increases patient risk as determined by PI.
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For patients participating in the MRI data collection component of the study, we will exclude the participants who meet the following criteria:
- . Any metallic objects in the body. Metal plates, certain types of dental braces, cardiac pacemakers, ext., that are sensitive to electromagnetic fields contraindicate MRI scans
- . Claustrophobia
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Pregnancy as documented in the medical record
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Combination Therapy (BLT+MT+MP with CBT)
Patients receive Melatonin (called MT) PO QD for 6 weeks, Methylphenidate (called MP) PO BID for 6 weeks, Bright Light Therapy (called BLT) for 30 minutes daily for 6 weeks, and Cognitive Behavior Therapy (called CBT) weekly for 6 weeks. |
Given by PO
Andere namen:
Given by PO
Andere namen:
Given by PO
Andere namen:
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Experimenteel: Placebo (CLT+ placebo MT + placebo MP with CBT)
Patients receive placebo Melatonin (called placebo MT) PO QD for 6 weeks, placebo Methylphenidate (called placebo MP) PO BID for 6 weeks, Control Light Therapy (called CLT) for 30 minutes daily for 6 weeks and Cognitive Behavior Therapy (called CBT) weekly for 6 weeks. |
Given by PO
Andere namen:
Given by PO
Andere namen:
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Experimenteel: Bright light and Melatonin (BLT + MT+ placebo MP with CBT)
Patients receive Bright Light Therapy (called BLT) for 30 minutes daily for 6 weeks, Melatonin (called MT) PO QD for 6 weeks, placebo Methylphenidate (called placebo MP) PO BID for 6 weeks, and Cognitive Behavior Therapy (called CBT) weekly for 6 weeks. |
Given by PO
Andere namen:
Given by PO
Andere namen:
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Experimenteel: Methylphenidate (CLT + placebo MT + MP with CBT)
Patients receive Control Light Therapy (called CLT) for 30 minutes daily for 6 weeks, placebo Melatonin (called placebo MT) PO QD for 6 weeks, Methylphenidate (called MP) PO BID for 6 weeks, and Cognitive Behavior Therapy (called CBT) weekly for 6 weeks. |
Given by PO
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Pittsburgh Sleep Quality Index (PSQI) questionnaires
Tijdsspanne: Through the study completion, an average of 1 year.
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Pittsburgh Sleep Quality Index (PSQI) questionnaire score on a 4-point scale ranging from 0 (not during the 2 weeks) to 3 (3 or more times a week). |
Through the study completion, an average of 1 year.
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Sriram Yennu, MD, MD Anderson
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Psychische aandoening
- Gedragssymptomen
- Pathologische aandoeningen, tekenen en symptomen
- Gedrag
- Tekenen en symptomen
- Neoplasmata
- Angst stoornissen
- Depressie
- Vermoeidheid
- Hormonen
- Hormonen, hormoonvervangers en hormoonantagonisten
- Organische chemicaliën
- Heterocyclische verbindingen, 1-ring
- Heterocyclische verbindingen
- Heterocyclische verbindingen, 2-ring
- Heterocyclische verbindingen, gefuseerd ring
- Carbonzuren
- Piperidines
- Indolen
- Gedragstherapie
- Psychotherapie
- Gedragsdisciplines en activiteiten
- Zuren, carbocyclisch
- Tryptamines
- Fenylacetaten
- Methylfenidaat
- Melatonine
- Cognitieve gedragstherapie
Andere studie-ID-nummers
- 2022-0180
- NCI-2022-06045 (Andere identificatie: NCI-CTRP Clinical Trials Reporting Registry)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
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