Cognitive Behavioral Therapy and Multimodal Therapy in Treating Sleep Disturbance in Patients With Cancer
NCT ID: NCT01628029
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
68 participants
INTERVENTIONAL
2014-01-15
2025-12-31
Brief Summary
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Detailed Description
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I. To obtain preliminary estimates of the effects of cognitive behavioral therapy (CBT) and various treatments (light therapy, melatonin, methylphenidate \[methylphenidate hydrochloride\]) and combinations of treatments in multimodal therapy (MMT) in reducing sleep disturbance in patients with cancer, as measured by change in Pittsburgh Sleep Quality Index (PSQI) scores taken at baseline and on day 15.
SECONDARY OBJECTIVES:
I. To explore the effect of MMT on Insomnia Severity Index, cancer related symptoms (fatigue \[Functional Assessment of Chronic Illness Therapy (FACIT-F) subscale, Edmonton Symptom Assessment System (ESAS)\], anxiety, depression anxiety \[Hospital Anxiety Depression Scale (HADS), ESAS\]), quality of life (Functional Assessment of Cancer Therapy-General \[FACT-G\], ESAS), and physical activity/sleep efficacy (actigraphy), before and after treatment with various sleep disturbance (SD) treatment combinations of MMT.
II. To determine the safety of MMT (type, frequency, and severity of the adverse events).
OUTLINE: Patients are randomized to 1 of 8 treatment arms.
ARM I: Patients undergo CBT comprising 3 30-minute counseling sessions between baseline and day 14. Patients also receive methylphenidate hydrochloride orally (PO) twice daily (BID) and therapeutic melatonin PO once daily (QD), and undergo light therapy over 30 minutes for 15 days.
ARM II: Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and melatonin placebo PO QD, and undergo sham light therapy over 30 minutes for 15 days.
ARM III: Patients undergo CBT as in Arm I. Patients also receive methylphenidate hydrochloride PO BID and therapeutic melatonin PO QD, and undergo sham light therapy over 30 minutes for 15 days.
ARM IV: Patients undergo CBT as in Arm I. Patients also receive methylphenidate hydrochloride PO BID and melatonin placebo PO QD, and undergo light therapy over 30 minutes for 15 days.
ARM V: Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and therapeutic melatonin PO QD, and undergo light therapy over 30 minutes for 15 days.
ARM VI: Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and melatonin placebo PO QD, and undergo light therapy over 30 minutes for 15 days.
ARM VII: Patients undergo CBT as in Arm I. Patients also receive methylphenidate hydrochloride PO BID and melatonin placebo PO QD, and undergo sham light therapy over 30 minutes for 15 days.
ARM VIII: Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and therapeutic melatonin PO QD, and undergo sham light therapy over 30 minutes for 15 days.
Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up on days 29 and 45.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Arm I (methylphenidate, melatonin, light therapy, CBT)
Patients undergo CBT comprising 3 30-minute counseling sessions between baseline and day 14. Patients also receive methylphenidate hydrochloride PO BID and therapeutic melatonin PO QD, and undergo light therapy over 30 minutes for 15 days.
Counseling
Undergo CBT
Methylphenidate Hydrochloride
Given PO
Phototherapy
Undergo light therapy
Quality-of-Life Assessment
Ancillary studies
Therapeutic Melatonin
Given PO
Arm II (placebo, placebo, sham light therapy, CBT)
Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and melatonin placebo PO QD, and undergo sham light therapy over 30 minutes for 15 days.
Counseling
Undergo CBT
Placebo Administration
Given PO
Quality-of-Life Assessment
Ancillary studies
Sham Intervention
Undergo sham light therapy
Arm III (methylphenidate, melatonin, sham light therapy, CBT)
Patients undergo CBT as in Arm I. Patients also receive methylphenidate hydrochloride PO BID and therapeutic melatonin PO QD, and undergo sham light therapy over 30 minutes for 15 days.
Counseling
Undergo CBT
Methylphenidate Hydrochloride
Given PO
Quality-of-Life Assessment
Ancillary studies
Sham Intervention
Undergo sham light therapy
Therapeutic Melatonin
Given PO
Arm IV (methylphenidate, placebo, light therapy, CBT)
Patients undergo CBT as in Arm I. Patients also receive methylphenidate hydrochloride PO BID and melatonin placebo PO QD, and undergo light therapy over 30 minutes for 15 days.
Counseling
Undergo CBT
Methylphenidate Hydrochloride
Given PO
Phototherapy
Undergo light therapy
Placebo Administration
Given PO
Quality-of-Life Assessment
Ancillary studies
Arm V (placebo, melatonin, light therapy, CBT)
Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and therapeutic melatonin PO QD, and undergo light therapy over 30 minutes for 15 days.
Counseling
Undergo CBT
Phototherapy
Undergo light therapy
Placebo Administration
Given PO
Quality-of-Life Assessment
Ancillary studies
Therapeutic Melatonin
Given PO
Arm VI (placebo, placebo, light therapy, CBT)
Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and melatonin placebo PO QD, and undergo light therapy over 30 minutes for 15 days.
Counseling
Undergo CBT
Phototherapy
Undergo light therapy
Placebo Administration
Given PO
Quality-of-Life Assessment
Ancillary studies
Arm VII (methylphenidate, placebo, sham light therapy, CBT)
Patients undergo CBT as in Arm I. Patients also receive methylphenidate hydrochloride PO BID and melatonin placebo PO QD, and undergo sham light therapy over 30 minutes for 15 days.
Counseling
Undergo CBT
Methylphenidate Hydrochloride
Given PO
Placebo Administration
Given PO
Quality-of-Life Assessment
Ancillary studies
Sham Intervention
Undergo sham light therapy
Arm VIII (placebo, melatonin, sham light intervention, CBT)
Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and therapeutic melatonin PO QD, and undergo sham light therapy over 30 minutes for 15 days.
Counseling
Undergo CBT
Placebo Administration
Given PO
Quality-of-Life Assessment
Ancillary studies
Sham Intervention
Undergo sham light therapy
Therapeutic Melatonin
Given PO
Interventions
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Counseling
Undergo CBT
Methylphenidate Hydrochloride
Given PO
Phototherapy
Undergo light therapy
Placebo Administration
Given PO
Quality-of-Life Assessment
Ancillary studies
Sham Intervention
Undergo sham light therapy
Therapeutic Melatonin
Given PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients should have a Zubrod =\< 2
* Patients with no pain and with stable pain (defined as pain under control and on stable doses of opioids for 1 week) are eligible
* Memorial delirium assessment scale =\< 13
* Controlled pain and depression symptoms, if present (defined as no change in the morphine equivalent dose of 30% or change in the dose of antidepressant medication in the past 2 weeks)
* All patients who are receiving chemotherapy and/or radiation therapy are eligible for study if they have completed \> 1 week of radiation therapy, and if they have been approved to go on study by their primary oncologist; the principal investigator (PI)/designated research staff of this study will obtain and document approval from the primary oncologist and principal investigator of the clinical trial in case the patient is on another clinical trial as referenced in the patient's study documents
* Serum creatinine =\< 2.0 mg/dL
* Total bilirubin =\< 1.5 mg/dL
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2 x upper limit of normal (ULN) or =\< 5 x ULN if hepatic metastases are present
* Patients on stable doses (defined as same dose for 2 weeks) of dexamethasone, mirtazapine, zolpidem, benzodiazepines, phenothiazines are allowed to participate in the study
Exclusion Criteria
* Currently taking MP or have taken it within the previous 10 days
* Patients with a diagnosis of polysomnographically confirmed obstructive sleep apnea or narcolepsy
* Regularly used cognitive behavioral therapy in the last 6 weeks for sleep disturbance
* Unable to complete the baseline assessment forms or to understand the recommendations for participation in the study
* Currently with a diagnosis of major depression, manic depressive disorder, obsessive-compulsive disorder, or schizophrenia)
* Need monoamine oxidase inhibitors, tricyclic antidepressants, or clonidine
* Have glaucoma
* Symptomatic tachycardia and uncontrolled hypertension (determined to be clinically significant by the PI)
* Currently receiving anticonvulsants (phenobarbital, diphenylhydantoin, primidone), phenylbutazone, clonidine, and/or tricyclic drugs (imipramine, clomipramine, or desipramine)
* Unable to speak and understand English
* Persons with congenital blindness and self-reported acquired blindness (independent of the cause) with no light perception
* Patients with a history of retinal disease
* Patients with \> 2 hours of direct exposure to outdoor natural light per day by interview with the Study Coordinator
* Patients with a diagnosis of obesity hypoventilation syndrome
* Positive pregnancy test for women of childbearing potential, as defined by intact uterus and ovaries, and a history of menses within the last 12 months; pregnancy test to be performed no greater than 14 days prior to consent in study; in cases of women with elevated beta (b)-human chorionic gonadotropin (HCG), these candidates will be eligible to participate so long as the level of b-HCG is not consistent with pregnancy; women of childbearing potential need to be on or use contraception, or be abstinent during the study period; their male partners must also use contraception (condom) or maintain abstinence; birth control specifications: women who are able to become pregnant must use birth control during the study and for 30 days after
* Women who are nursing
* Patients who have taken melatonin within the past two weeks
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Sriram Yennu
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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References
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Yennurajalingam S, Carmack C, Balachandran D, Eng C, Lim B, Delgado M, Guzman Gutierrez D, Raznahan M, Park M, Hess KR, Williams JL, Lu Z, Ochoa J, Bruera E. Sleep disturbance in patients with cancer: a feasibility study of multimodal therapy. BMJ Support Palliat Care. 2021 Jun;11(2):170-179. doi: 10.1136/bmjspcare-2019-001877. Epub 2020 Jan 10.
Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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NCI-2012-01352
Identifier Type: REGISTRY
Identifier Source: secondary_id
2012-0120
Identifier Type: OTHER
Identifier Source: secondary_id
2012-0120
Identifier Type: -
Identifier Source: org_study_id