Clinical trial NCT02410564: CBT-I Intervention for Insomnia in Newly Diagnosed Cancer Patients
Official title: Testing an Accessible Cognitive Behavioral Therapy for Insomnia (CBT-I) Intervention in Newly Diagnosed Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cancer
Chronic Insomnia
Keywords: insomnia
Sleep
CBT-I intervention
SHUTi
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Massey Cancer Center
First posted: 2015-04-07
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: The proposed study will be a randomized controlled trial design. Participants will be randomized to either a CBTI treatment or a wait list control condition. The intervention is SHUTi, a validated web based version of CBTI, which will take place over seven weeks and will include a combination of face to face and telephone sessions, and email updates. All participants will have a face to face meeting with the doctoral student at enrollment. During the intervention period, all participants will be contacted by telephone at week 1, 3, and 6 to check in and to encourage participant engagement. However, during phone calls with control participants, no advice regarding sleep will be given and if participants ask, they will be informed that such advice can be provided in a few weeks if they choose to crossover to the treatment condition at the end of the study. Participants in SHUTi will additionally be provided the the doctoral student's phone number and will be encouraged to contact her if they have any questions during the intervention. They will also have the option of setting up appointments for face to face meetings during a clinic appointment if they desire additional therapist guidance. Pretreatment, all participants will complete a two week sleep diary and multiple self report measures. At the end of the intervention, all participants will complete a two week sleep diary and multiple self report measures again.

Eligibility criteria: Inclusion criteria:

* 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.

Exclusion criteria:

* 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

Primary outcomes:
measure: To determine the efficacy of a CBT-I intervention that improves sleep and quality of life outcomes during cancer treatment.
timeFrame: 1 year
Secondary outcomes:
measure: To assess the feasibility of a CBT--I intervention among newly diagnosed cancer patients.
timeFrame: 1 year
measure: To assess the acceptability of a CBT--I intervention among newly diagnosed cancer patients.
timeFrame: 1 year
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University/Massey Cancer Center
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Bruce Rybarczyk, PhD
role: PRINCIPAL_INVESTIGATOR
References: