Cognitive Behavioral Therapy and Multimodal Therapy in Treating Sleep Disturbance in Patients With Cancer

• Status: Active, not recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Melatonin; Methylphenidate

Criteria

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