CBT-I Intervention for Insomnia in Newly Diagnosed Cancer Patients

Stopped early · Not applicable

Conditions studied: Cancer, Chronic Insomnia

In brief

To determine the efficacy of a CBT-I intervention in improving sleep and other quality of life outcomes during cancer treatment. To assess the feasibility and acceptability of a CBT-I intervention among newly diagnosed cancer patients.

Key facts

Study ID

NCT02410564

Run by

Virginia Commonwealth University

People needed

29

Starts

2014-12-01

Expected to finish

2016-01-01

Last updated by the study team

2016-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• newly diagnosed with I-III non-metastatic cancer
• scheduled to begin chemotherapy or radiotherapy
• chemotherapy or radiotherapynaïve
• meet diagnostic criteria for chronic insomnia (i.e., lasting for at least one month)
• Chronic insomnia has been defined in previous research:as the presence of (1) three or more episodes of insomnia (i.e., ≥ 30minuteSOL, ≥ 60minute wake after sleep onset (WASO), or ≤ 6.5 hour total sleep time (TST) per night) of per week and (2) daytime effects of insomnia, such as irritability, difficulty concentrating, or fatigue for at least one month.
• interested in behavioral sleep treatment
• have the permission of their oncologists to participate.

You may not qualify if…

• untreated alcohol or substance abuse or dependence, bipolar, or psychotic disorder
• medical conditions such as seizure disorder, restless leg disorder, or Parkinson's disease
• untreated sleep disorders such as sleep apnea

Where it is running

• Virginia Commonwealth University/Massey Cancer Center — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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