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.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
68
Undergo CBT
Given PO
Undergo light therapy
Given PO
Ancillary studies
Undergo sham light therapy
Given PO
M D Anderson Cancer Center
Houston, Texas, United States
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.
Time frame: Baseline and Day 15
Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) Subscale Score Change
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.
Time frame: Baseline and Day 15
Insomnia Severity Index (ISI)) Score Change
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.
Time frame: Baseline and Day 15
Functional Assessment of Cancer Therapy - General (FACT-G) Score Change
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.
Time frame: Baseline and Day 15
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.