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

NCT01628029 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2012-0120NCI-2012-01352
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm; Sleep Disorder

Outcome Measures

Primary Outcomes (1)

• Pittsburgh Sleep Quality Index (PSQI) Score Change

  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 Outcomes (3)

• Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) Subscale Score Change

  Baseline and Day 15

• Insomnia Severity Index (ISI)) Score Change

  Baseline and Day 15

• Functional Assessment of Cancer Therapy - General (FACT-G) Score Change

  Baseline and Day 15

Study Arms (8)

Arm I (methylphenidate, melatonin, light therapy, CBT)

EXPERIMENTAL

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.

Other: Counseling; Drug: Methylphenidate Hydrochloride; Procedure: Phototherapy; Other: Quality-of-Life Assessment; Drug: Therapeutic Melatonin

Arm II (placebo, placebo, sham light therapy, CBT)

EXPERIMENTAL

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.

Other: Counseling; Other: Placebo Administration; Other: Quality-of-Life Assessment; Procedure: Sham Intervention

Arm III (methylphenidate, melatonin, sham light therapy, CBT)

EXPERIMENTAL

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.

Other: Counseling; Drug: Methylphenidate Hydrochloride; Other: Quality-of-Life Assessment; Procedure: Sham Intervention; Drug: Therapeutic Melatonin

Arm IV (methylphenidate, placebo, light therapy, CBT)

EXPERIMENTAL

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.

Other: Counseling; Drug: Methylphenidate Hydrochloride; Procedure: Phototherapy; Other: Placebo Administration; Other: Quality-of-Life Assessment

Arm V (placebo, melatonin, light therapy, CBT)

EXPERIMENTAL

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.

Other: Counseling; Procedure: Phototherapy; Other: Placebo Administration; Other: Quality-of-Life Assessment; Drug: Therapeutic Melatonin

Arm VI (placebo, placebo, light therapy, CBT)

EXPERIMENTAL

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.

Other: Counseling; Procedure: Phototherapy; Other: Placebo Administration; Other: Quality-of-Life Assessment

Arm VII (methylphenidate, placebo, sham light therapy, CBT)

EXPERIMENTAL

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.

Other: Counseling; Drug: Methylphenidate Hydrochloride; Other: Placebo Administration; Other: Quality-of-Life Assessment; Procedure: Sham Intervention

Arm VIII (placebo, melatonin, sham light intervention, CBT)

EXPERIMENTAL

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.

Other: Counseling; Other: Placebo Administration; Other: Quality-of-Life Assessment; Procedure: Sham Intervention; Drug: Therapeutic Melatonin

Interventions

Methylphenidate Hydrochloride DRUG

Given PO

Also known as: Concerta, Quillivant XR, Ritalin

Arm I (methylphenidate, melatonin, light therapy, CBT); Arm III (methylphenidate, melatonin, sham light therapy, CBT); Arm IV (methylphenidate, placebo, light therapy, CBT); Arm VII (methylphenidate, placebo, sham light therapy, CBT)

Placebo Administration OTHER

Given PO

Arm II (placebo, placebo, sham light therapy, CBT); Arm IV (methylphenidate, placebo, light therapy, CBT); Arm V (placebo, melatonin, light therapy, CBT); Arm VI (placebo, placebo, light therapy, CBT); Arm VII (methylphenidate, placebo, sham light therapy, CBT); Arm VIII (placebo, melatonin, sham light intervention, CBT)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (methylphenidate, melatonin, light therapy, CBT); Arm II (placebo, placebo, sham light therapy, CBT); Arm III (methylphenidate, melatonin, sham light therapy, CBT); Arm IV (methylphenidate, placebo, light therapy, CBT); Arm V (placebo, melatonin, light therapy, CBT); Arm VI (placebo, placebo, light therapy, CBT); Arm VII (methylphenidate, placebo, sham light therapy, CBT); Arm VIII (placebo, melatonin, sham light intervention, CBT)

Sham Intervention PROCEDURE

Undergo sham light therapy

Also known as: Sham Comparator

Arm II (placebo, placebo, sham light therapy, CBT); Arm III (methylphenidate, melatonin, sham light therapy, CBT); Arm VII (methylphenidate, placebo, sham light therapy, CBT); Arm VIII (placebo, melatonin, sham light intervention, CBT)

Therapeutic Melatonin DRUG

Given PO

Also known as: Circadin, Melatonin, Melaxen

Arm I (methylphenidate, melatonin, light therapy, CBT); Arm III (methylphenidate, melatonin, sham light therapy, CBT); Arm V (placebo, melatonin, light therapy, CBT); Arm VIII (placebo, melatonin, sham light intervention, CBT)

Counseling OTHER

Undergo CBT

Also known as: Counseling Intervention

Arm I (methylphenidate, melatonin, light therapy, CBT); Arm II (placebo, placebo, sham light therapy, CBT); Arm III (methylphenidate, melatonin, sham light therapy, CBT); Arm IV (methylphenidate, placebo, light therapy, CBT); Arm V (placebo, melatonin, light therapy, CBT); Arm VI (placebo, placebo, light therapy, CBT); Arm VII (methylphenidate, placebo, sham light therapy, CBT); Arm VIII (placebo, melatonin, sham light intervention, CBT)

Phototherapy PROCEDURE

Undergo light therapy

Also known as: Actinotherapy, Bright Light Therapy, light therapy

Arm I (methylphenidate, melatonin, light therapy, CBT); Arm IV (methylphenidate, placebo, light therapy, CBT); Arm V (placebo, melatonin, light therapy, CBT); Arm VI (placebo, placebo, light therapy, CBT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 31924662 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Hematologic Neoplasms; Sleep Wake Disorders

Interventions

Counseling; Methylphenidate; Phototherapy; Ultraviolet Therapy; Melatonin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Sriram Yennu, MD
• Organization: M.D. Anderson Cancer Center

syennu@mdanderson.org

713-792-6085

Study Officials

• Sriram Yennu

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2012
• First Posted: June 26, 2012
• Study Start: January 15, 2014
• Primary Completion: December 22, 2025
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 4, 2026
• Results First Posted: February 4, 2026

Record last verified: 2026-02

Locations

US (1)