Cognitive Behavioral Therapy and Multimodal Therapy in Treating Sleep Disturbance in Patients With Cancer
May 19, 2026 updated by: M.D. Anderson Cancer Center
Multimodal Therapy for the Treatment of Sleep Disturbance in Patients With Cancer
This randomized phase II trial studies how well cognitive behavioral therapy and multimodal therapy works in treating sleep disturbance in patients with cancer.
Cognitive behavioral therapy may help reduce sleep disturbances, fatigue, and insomnia as well as improve the well-being and quality of life of patients with cancer when given together with methylphenidate hydrochloride, therapeutic melatonin, and light therapy.
Study Overview
Status
Active, not recruiting
Detailed Description
PRIMARY OBJECTIVE:
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.
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Cancer patients currently on cancer therapy with a positive screening for SD (screening PSQI score >= 5)
- 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:
- Have a major contraindication to methylphenidate (MP) (e.g., allergy/hypersensitivity to study medications or their constituents), light therapy (e.g., currently receiving ultraviolet A [UVA]/ultraviolet B [UVB] therapy), cognitive behavioral therapy (e.g., schizophrenia), or conditions making adherence difficult as determined by the attending physician
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
Ancillary studies
Other Names:
Undergo CBT
Other Names:
Given PO
Other Names:
Undergo light therapy
Other Names:
Given PO
Other Names:
|
|
Experimental: 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.
|
Ancillary studies
Other Names:
Given PO
Undergo CBT
Other Names:
Undergo sham light therapy
Other Names:
|
|
Experimental: 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.
|
Ancillary studies
Other Names:
Undergo CBT
Other Names:
Given PO
Other Names:
Given PO
Other Names:
Undergo sham light therapy
Other Names:
|
|
Experimental: 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.
|
Ancillary studies
Other Names:
Given PO
Undergo CBT
Other Names:
Given PO
Other Names:
Undergo light therapy
Other Names:
|
|
Experimental: 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.
|
Ancillary studies
Other Names:
Given PO
Undergo CBT
Other Names:
Undergo light therapy
Other Names:
Given PO
Other Names:
|
|
Experimental: 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.
|
Ancillary studies
Other Names:
Given PO
Undergo CBT
Other Names:
Undergo light therapy
Other Names:
|
|
Experimental: 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.
|
Ancillary studies
Other Names:
Given PO
Undergo CBT
Other Names:
Given PO
Other Names:
Undergo sham light therapy
Other Names:
|
|
Experimental: 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.
|
Ancillary studies
Other Names:
Given PO
Undergo CBT
Other Names:
Given PO
Other Names:
Undergo sham light therapy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pittsburgh Sleep Quality Index (PSQI) Score Change
Time Frame: Baseline and Day 15
|
PSQI consists of 19 items, and it measures several different aspects of sleep, offering seven component scores and one composite score.
The component scores consist of subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
Each component score ranges from 0 (no difficulty/good) to 3 (severe difficulty/poor).
The global PSQI score is then calculated by totaling (summed) seven component scores, providing an overall score ranging from 0 to 21, where 0 indicates very good sleep quality and 21 signifies very poor sleep quality.
A global score of greater than 5 often suggests significant sleep problems.
In this study, Wilcoxon signed-rank test was used to determine the p value.
|
Baseline and Day 15
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) Subscale Score Change
Time Frame: Baseline and Day 15
|
There are 13 items in this FACIT-F subscale.
In this subscale, the patient rates the intensity of fatigue and its related symptoms on a scale from 0 to 4 in the past week.
The total score can range between 0 and 52, with higher scores denoting less fatigue.
Wilcoxon signed-rank test was used to determine the p-value.
|
Baseline and Day 15
|
|
Insomnia Severity Index (ISI)) Score Change
Time Frame: Baseline and Day 15
|
The ISI is a 7-item questionnaire designed to evaluate insomnia severity.
Each item is rated using a 5-point Likert scale ranging from 0 (not at all) to 4 (very much), for a total score ranging from 0 to 28 with a cut-off score of 10 or greater indicating significant insomnia.
Wilcoxon signed-rank test was used to determine the p-value.
|
Baseline and Day 15
|
|
Functional Assessment of Cancer Therapy - General (FACT-G) Score Change
Time Frame: Baseline and Day 15
|
The FACT-G is a quality-of-life instrument that is commonly used in cancer clinical trials.
FACT-G consists of 27 general quality-of-life questions divided into 4 domains (physical, social, emotional and functional).
The patient rates the intensity of symptoms on a Likert scale from 0 (not at all) to 4 (very much).
Total score ranges from 0-108 with higher score indicates better Quality of Life.
Wilcoxon signed-rank test was used to determine the p-value.
|
Baseline and Day 15
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sriram Yennu, M.D. Anderson Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 15, 2014
Primary Completion (Actual)
December 22, 2025
Study Completion (Estimated)
December 31, 2028
Study Registration Dates
First Submitted
June 22, 2012
First Submitted That Met QC Criteria
June 25, 2012
First Posted (Estimated)
June 26, 2012
Study Record Updates
Last Update Posted (Actual)
May 22, 2026
Last Update Submitted That Met QC Criteria
May 19, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Neoplasms by Site
- Neoplasms
- Hematologic Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Hemic and Lymphatic Diseases
- Hematologic Neoplasms
- Sleep Wake Disorders
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Organic Chemicals
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Therapeutics
- Carboxylic Acids
- Piperidines
- Indoles
- Health Services
- Health Care Facilities Workforce and Services
- Community Health Services
- Behavioral Disciplines and Activities
- Mental Health Services
- Acids, Carbocyclic
- Tryptamines
- Phenylacetates
- Methylphenidate
- Melatonin
- Counseling
- Phototherapy
- Ultraviolet Therapy
Other Study ID Numbers
- 2012-0120 (Other Identifier: M D Anderson Cancer Center)
- NCI-2012-01352 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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