Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- Severity of insomnia as assessed by the insomnia severity index and daily sleeep diaries.
研究概览
简要总结
RATIONALE: Sleep disorder counseling may reduce fatigue and insomnia as well as improve the well-being and quality of life of cancer survivors. Armodafinil may help relieve insomnia and fatigue in patients with cancer after chemotherapy. PURPOSE: This randomized phase II trial is studying how well cognitive behavioral therapy with or without armodafinil works in treating cancer survivors with insomnia and fatigue after chemotherapy.
详细描述
Detailed DescriptionOBJECTIVES:
I. To determine if one or more of the intervention strategies (i.e., CBT-I, armodafinil, or both), when compared to a placebo only group, reduce insomnia in cancer patients following the conclusion of chemotherapy and/or radiation therapy.
II. To determine if one or more of the intervention strategies (i.e, CBT-I, armodafinil, or both), when compared to a placebo only group, reduce fatigue in cancer patients following the conclusion of chemotherapy and/or radiation therapy.
III. To determine if one or more of the intervention strategies (i.e., CBT-I, armodafinil, or both), when compared to a placebo only group, improve QOL in cancer patients following the conclusion of chemotherapy and/or radiation therapy.
OUTLINE: Patients are randomized to 1 of 4 treatment arms (cognitive behavioral therapy, armodafinil, both, or neither).
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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of cancer
- •Be able to understand written and spoken English
- •Be able to swallow medication
- •Have preferred sleep phase between 7:30 pm and 11:00 am
- •Be willing to discontinue any medications /OTCs/Herbals for sleep for the 11-week study period
- •Be presumed to be in a state of cancer remission; use of tamoxifen, an aromatase inhibitor, and/or Herceptin is permitted
- •Self-report problems with insomnia for at least three months and that the insomnia began or got worse with the onset of cancer or treatment
- •At least one month must have passed since completion of chemotherapy and/or radiation treatment
- •Report insomnia on the SDS-CL at a frequency of at least 3 days a week
排除标准
- •Have ever taken modafinil or armodafinil had CBT-I therapy (CBT-I therapy for the sake of this protocol will be defined as any cognitive behavioral-based treatment for insomnia that includes a sleep restriction component)
- •Have an unstable medical or psychiatric illness (Axis I- current or within the last 5 years)
- •Have a history of seizures or severe headaches, or uncontrolled cardiac disease or hypertension
- •Be presently taking an anticoagulant or a corticosteroid
- •Have taken amphetamines (e.g., methylphenidate, pemoline [Cylert] or similar psycho stimulants) within the past 30 days
- •Be currently pregnant or nursing
- •Have a history of substance abuse, or meet criteria for current alcohol abuse or dependence as assessed by a CAGE test score >= 2 or an Alcohol Use Disorders Identification Test (AUDIT) score >= 13
- •Have surgery planned within the study period
- •Have ever been diagnosed with sleep apnea or have sleep apnea as indicated by endorsing either question 11 (I wake up choking or gasping for air) or question 12 (My bed partner has noticed that I seem to stop breathing) on the Sleep Disorders Symptom Check at the "Often" or "Frequently" level
- •Have serious RLS/PLMs indicated by endorsing two or more items associated with RLS/PLMs on the Sleep Disorders Symptom Check at the "Frequently" level
研究组 & 干预措施
Arm I
Patients receive oral placebo twice daily for 47 days.
干预措施: Quality-of-life assessment (Procedure)
Arm I
Patients receive oral placebo twice daily for 47 days.
干预措施: Questionnaire Administration (Other)
Arm I
Patients receive oral placebo twice daily for 47 days.
干预措施: Placebo (Other)
Arm I
Patients receive oral placebo twice daily for 47 days.
干预措施: Fatigue assessment and management (Procedure)
Arm II
Patients receive oral armodafinil twice daily for 47 days.
干预措施: Sleep disorder therapy (Procedure)
Arm II
Patients receive oral armodafinil twice daily for 47 days.
干预措施: Armodafinil (Drug)
Arm II
Patients receive oral armodafinil twice daily for 47 days.
干预措施: Quality-of-life assessment (Procedure)
Arm II
Patients receive oral armodafinil twice daily for 47 days.
干预措施: Questionnaire Administration (Other)
Arm II
Patients receive oral armodafinil twice daily for 47 days.
干预措施: Fatigue assessment and management (Procedure)
Arm II
Patients receive oral armodafinil twice daily for 47 days.
干预措施: Management of Therapy (Procedure)
Arm III
Patients receive oral placebo twice daily for 47 days. Patients undergo cognitive behavioral therapy for insomnia comprising sleep restriction therapy, stimulus control instruction, sleep hygiene guidelines, and a session of cognitive therapy for 7 weeks.
干预措施: Sleep disorder therapy (Procedure)
Arm III
Patients receive oral placebo twice daily for 47 days. Patients undergo cognitive behavioral therapy for insomnia comprising sleep restriction therapy, stimulus control instruction, sleep hygiene guidelines, and a session of cognitive therapy for 7 weeks.
干预措施: Cognitive Assessment (Procedure)
Arm III
Patients receive oral placebo twice daily for 47 days. Patients undergo cognitive behavioral therapy for insomnia comprising sleep restriction therapy, stimulus control instruction, sleep hygiene guidelines, and a session of cognitive therapy for 7 weeks.
干预措施: Quality of Life Assessment (Procedure)
Arm III
Patients receive oral placebo twice daily for 47 days. Patients undergo cognitive behavioral therapy for insomnia comprising sleep restriction therapy, stimulus control instruction, sleep hygiene guidelines, and a session of cognitive therapy for 7 weeks.
干预措施: Questionnaire Administration (Other)
Arm III
Patients receive oral placebo twice daily for 47 days. Patients undergo cognitive behavioral therapy for insomnia comprising sleep restriction therapy, stimulus control instruction, sleep hygiene guidelines, and a session of cognitive therapy for 7 weeks.
干预措施: Placebo (Other)
Arm III
Patients receive oral placebo twice daily for 47 days. Patients undergo cognitive behavioral therapy for insomnia comprising sleep restriction therapy, stimulus control instruction, sleep hygiene guidelines, and a session of cognitive therapy for 7 weeks.
干预措施: Fatigue assessment and management (Procedure)
Arm III
Patients receive oral placebo twice daily for 47 days. Patients undergo cognitive behavioral therapy for insomnia comprising sleep restriction therapy, stimulus control instruction, sleep hygiene guidelines, and a session of cognitive therapy for 7 weeks.
干预措施: Management of therapy and complications (Procedure)
Arm IV
Patients receive oral armodafinil twice daily for 47 days. Patients undergo cognitive behavioral therapy for insomnia as in Arm III for 7 weeks.
干预措施: Sleep disorder therapy (Procedure)
Arm IV
Patients receive oral armodafinil twice daily for 47 days. Patients undergo cognitive behavioral therapy for insomnia as in Arm III for 7 weeks.
干预措施: Armodafinil (Drug)
Arm IV
Patients receive oral armodafinil twice daily for 47 days. Patients undergo cognitive behavioral therapy for insomnia as in Arm III for 7 weeks.
干预措施: Cognitive Assessment (Procedure)
Arm IV
Patients receive oral armodafinil twice daily for 47 days. Patients undergo cognitive behavioral therapy for insomnia as in Arm III for 7 weeks.
干预措施: Quality of Life Assessment (Procedure)
Arm IV
Patients receive oral armodafinil twice daily for 47 days. Patients undergo cognitive behavioral therapy for insomnia as in Arm III for 7 weeks.
干预措施: Questionnaire Administration (Other)
Arm IV
Patients receive oral armodafinil twice daily for 47 days. Patients undergo cognitive behavioral therapy for insomnia as in Arm III for 7 weeks.
干预措施: Fatifue assessment and management (Procedure)
结局指标
主要结局
Severity of insomnia as assessed by the insomnia severity index and daily sleeep diaries.
Fatigue as assessed by the brief fatigue index
Adverse Events
时间窗: Mid-point and end of treatment
次要结局
- Fatigue as assessed by the functional assessment of chronic illness therapy-fatigue
- Sleep latency, wake after sleep onset, and total sleep time