Multimodal Therapy for the Treatment of Sleep Disturbance in Patients With Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Pittsburgh Sleep Quality Index (PSQI) Score Change
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Phototherapy (Procedure)
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.
干预措施: Counseling (Other)
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.
干预措施: Counseling (Other)
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.
干预措施: Phototherapy (Procedure)
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.
干预措施: Quality-of-Life Assessment (Other)
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.
干预措施: Counseling (Other)
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.
干预措施: Placebo Administration (Other)
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.
干预措施: Quality-of-Life Assessment (Other)
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.
干预措施: Sham Intervention (Procedure)
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.
干预措施: Counseling (Other)
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.
干预措施: Quality-of-Life Assessment (Other)
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.
干预措施: Sham Intervention (Procedure)
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.
干预措施: Placebo Administration (Other)
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.
干预措施: Quality-of-Life Assessment (Other)
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.
干预措施: Counseling (Other)
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.
干预措施: Phototherapy (Procedure)
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.
干预措施: Placebo Administration (Other)
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.
干预措施: Quality-of-Life Assessment (Other)
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.
干预措施: Counseling (Other)
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.
干预措施: Phototherapy (Procedure)
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.
干预措施: Placebo Administration (Other)
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.
干预措施: Quality-of-Life Assessment (Other)
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.
干预措施: Counseling (Other)
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.
干预措施: Placebo Administration (Other)
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.
干预措施: Quality-of-Life Assessment (Other)
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.
干预措施: Sham Intervention (Procedure)
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.
干预措施: Counseling (Other)
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.
干预措施: Placebo Administration (Other)
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.
干预措施: Quality-of-Life Assessment (Other)
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.
干预措施: Sham Intervention (Procedure)
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.
干预措施: Therapeutic Melatonin (Drug)
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.
干预措施: Methylphenidate Hydrochloride (Drug)
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.
干预措施: Methylphenidate Hydrochloride (Drug)
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.
干预措施: Therapeutic Melatonin (Drug)
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.
干预措施: Methylphenidate Hydrochloride (Drug)
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.
干预措施: Therapeutic Melatonin (Drug)
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.
干预措施: Methylphenidate Hydrochloride (Drug)
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.
干预措施: Therapeutic Melatonin (Drug)
结局指标
主要结局
Pittsburgh Sleep Quality Index (PSQI) Score Change
时间窗: 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.
次要结局
- 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)