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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Placebo Comparator | Patients receive oral placebo twice daily for 47 days. |
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| Arm II | Experimental | Patients receive oral armodafinil twice daily for 47 days. |
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| Arm III | Experimental | 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. |
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| Arm IV | Experimental | Patients receive oral armodafinil twice daily for 47 days. Patients undergo cognitive behavioral therapy for insomnia as in Arm III for 7 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quality-of-Life Assessment | Procedure | Ancillary Studies |
| |
| Questionnaire Administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue as assessed by the functional assessment of chronic illness therapy-fatigue | ||
| Sleep latency, wake after sleep onset, and total sleep time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Perlis, MD | Abramson Cancer Center at Penn Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41170811 | Derived | Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2. |
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| Other |
Ancillary Studies |
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| Placebo | Other | Given orally |
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| Fatigue Assessment and Management | Procedure |
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| Sleep Disorder Therapy | Procedure |
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| Armodafinil | Drug | Given orally |
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| Quality-of-life assessment | Procedure | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary Studies |
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| Fatigue Assessment and Management | Procedure |
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| Management of Therapy | Procedure |
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| Sleep disorder therapy | Procedure |
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| cognitive assessment | Procedure |
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| Quality of Life assessment | Procedure | Ancillary Studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Placebo | Other | Given orally |
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| Fatigue assessment and management | Procedure |
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| Management of therapy and complications | Procedure |
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| Sleep disorder therapy | Procedure |
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| Armodafinil | Drug | Given orally |
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| Cognitive Assessment | Procedure |
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| Quality of Life Assessment | Procedure | Quality of Life Assessment |
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| Questionnaire Administration | Other | Ancillary Studies |
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| Fatifue assessment and management | Procedure |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D000077408 | Modafinil |
| D054539 | Medication Therapy Management |
| D000073216 | Mental Status and Dementia Tests |
| ID | Term |
|---|---|
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010593 | Pharmaceutical Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D054524 | Medicare Part D |
| D007356 | Insurance, Pharmaceutical Services |
| D007348 | Insurance, Health |
| D007341 | Insurance |
| D005381 | Financing, Organized |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D006278 | Medicare |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D009483 | Neuropsychological Tests |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
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