Clinical trial NCT02756390: CBTI-CS: A Novel Cognitive-Behavioral Treatment for Insomnia in Cancer Survivors
Official title: CBTI-CS: A Novel Cognitive-Behavioral Treatment for Insomnia in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: Insomnia cancer Survivor
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-04-29
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research study is evaluating the effectiveness of a 3-session behavioral intervention for insomnia in cancer survivors. This is a behavioral intervention study, and no medications are involved.

Detailed description: This study is being done to test the usefulness of a 3-session cognitive-behavioral intervention for improving insomnia in cancer survivors. In this study, the investigators are testing whether this 3-session intervention (Cognitive Behavior Therapy for Insomnia in Cancer Survivors: CBTI-CS) will improve insomnia in cancer survivors whose continue to have insomnia symptoms after receiving sleep hygiene education.

In addition to the participants who will be offered sleep hygiene education and the 3-session CBTI-CS,10 additional participants will be recruited to participate in a pilot evaluation of the CBTI-CS intervention delivered via telehealth. This will be a pilot aspect of the study and data from these participants will be for descriptive purposes.

Eligibility criteria: Inclusion Criteria:

-≥ 18 years of age

* History of a cancer diagnosis
* No active cancer therapy (excluding chemoprevention) in the past year, and no cancer therapy planned in the next 6 months
* No surgery planned in the next 6 months
* Significant insomnia as evidenced by an Insomnia Severity Index score ≥12
* Able to read and write in English
* Willing to attend study group sessions
* Motivated and able to follow the demands of the CBTI-CS program, to keep sleep records, complete self-report symptom reports and make changes in their sleep schedule, including restricting their sleep.

Exclusion Criteria:

* Survivors who report ever being diagnosed with Bipolar Disorder will be excluded.
* Survivors who report ever being diagnosed with a Seizure Disorder or have experienced a seizure in the past 12 months will be excluded.
* Intention to adjust (decrease or increase) use of sedative, hypnotic, or over-the-counter medications that can affect sleep during the study period.
* Have diagnosed, untreated sleep apnea, or sleep apnea suspected by a physician but which has not been evaluated, or other sleep disorder
* Employment that involves irregular sleep patterns, such as shift-work or frequent long-distance travel that involves adjusting to different time zones, or employment in a position that could impact public safety (such as operating heavy machinery)
* Refusal to modify or reduce excessive alcohol use that is likely to interfere with an individual's sleep.

Primary outcomes:
measure: The Insomnia Severity Index (ISI)
timeFrame: Change from Baseline to 4-weeks post-intervention
Secondary outcomes:
measure: Profile of Mood States - Short Form (POMS-SF)
timeFrame: Change from Baseline to 4 & 8 weeks post-intervention
measure: The Insomnia Severity Index (ISI)
timeFrame: Change from Baseline to 8 weeks post-intervention
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Christopher Recklitis, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhou ES, Partridge AH, Recklitis CJ. A pilot trial of brief group cognitive-behavioral treatment for insomnia in an adult cancer survivorship program. Psychooncology. 2017 Jun;26(6):843-848. doi: 10.1002/pon.4096. Epub 2016 Feb 12.