Cognitive Behavioral Therapy With or Without Armodafinil in Treating Cancer Survivors With Insomnia and Fatigue After Chemotherapy

Phase 2

Completed

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Interventions: Procedure: Quality-of-life assessment
Procedure: Sleep disorder therapy
Other: Questionnaire Administration
Procedure: Cognitive Assessment
Drug: Armodafinil
Other: Placebo
Procedure: Quality of Life Assessment
Procedure: Fatigue assessment and management
Procedure: Management of Therapy
Procedure: Fatifue assessment and management
Procedure: Management of therapy and complications

Registration Number: NCT01019187

Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary: 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.

Detailed Description: 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).

After completion of study treatment, patients are followed for 30 days.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 226

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Arm I	Quality-of-life assessment	Patients receive oral placebo twice daily for 47 days.
Arm I	Questionnaire Administration	Patients receive oral placebo twice daily for 47 days.
Arm I	Placebo	Patients receive oral placebo twice daily for 47 days.
Arm I	Fatigue assessment and management	Patients receive oral placebo twice daily for 47 days.
Arm II	Sleep disorder therapy	Patients receive oral armodafinil twice daily for 47 days.
Arm II	Quality-of-life assessment	Patients receive oral armodafinil twice daily for 47 days.
Arm II	Questionnaire Administration	Patients receive oral armodafinil twice daily for 47 days.
Arm II	Fatigue assessment and management	Patients receive oral armodafinil twice daily for 47 days.
Arm II	Management of Therapy	Patients receive oral armodafinil twice daily for 47 days.
Arm III	Sleep disorder therapy	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.
Arm III	Cognitive Assessment	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.
Arm III	Quality of Life Assessment	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.
Arm III	Questionnaire Administration	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.
Arm III	Management of therapy and complications	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.
Arm IV	Sleep disorder therapy	Patients receive oral armodafinil twice daily for 47 days. Patients undergo cognitive behavioral therapy for insomnia as in Arm III for 7 weeks.
Arm IV	Cognitive Assessment	Patients receive oral armodafinil twice daily for 47 days. Patients undergo cognitive behavioral therapy for insomnia as in Arm III for 7 weeks.
Arm III	Placebo	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.
Arm III	Fatigue assessment and management	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.
Arm IV	Quality of Life Assessment	Patients receive oral armodafinil twice daily for 47 days. Patients undergo cognitive behavioral therapy for insomnia as in Arm III for 7 weeks.
Arm IV	Questionnaire Administration	Patients receive oral armodafinil twice daily for 47 days. Patients undergo cognitive behavioral therapy for insomnia as in Arm III for 7 weeks.
Arm IV	Fatifue assessment and management	Patients receive oral armodafinil twice daily for 47 days. Patients undergo cognitive behavioral therapy for insomnia as in Arm III for 7 weeks.
Arm II	Armodafinil	Patients receive oral armodafinil twice daily for 47 days.
Arm IV	Armodafinil	Patients receive oral armodafinil twice daily for 47 days. Patients undergo cognitive behavioral therapy for insomnia as in Arm III for 7 weeks.

Primary Outcome Measures

Name	Time	Method
Severity of insomnia as assessed by the insomnia severity index and daily sleeep diaries.
Fatigue as assessed by the brief fatigue index
Adverse Events	Mid-point and end of treatment

Secondary Outcome Measures