NCT01628029

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

Multimodal Therapy for the Treatment of Sleep Disturbance in Patients With Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Counseling	Undergo CBT
DRUG	Methylphenidate Hydrochloride	Given PO
PROCEDURE	Phototherapy	Undergo light therapy
OTHER	Placebo Administration	Given PO
OTHER	Quality-of-Life Assessment	Ancillary studies
PROCEDURE	Sham Intervention	Undergo sham light therapy
DRUG	Therapeutic Melatonin	Given PO

Timeline

• Start date: 2014-01-15
• Primary completion: 2025-12-22
• Completion: 2028-12-31
• First posted: 2012-06-26
• Last updated: 2026-02-04
• Results posted: 2026-02-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study