CBT-I Intervention for Insomnia in Newly Diagnosed Cancer Patients

Cancer Clinical Trial

Official title:

Testing an Accessible Cognitive Behavioral Therapy for Insomnia (CBT-I) Intervention in Newly Diagnosed Cancer Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02410564
• Other study ID #: MCC-14-10761
• Secondary ID: HM20002827
• Status: Terminated
• Phase: N/A
• First received: March 11, 2015
• Last updated: February 9, 2016
• Start date: December 2014
• Est. completion date: January 2016

Study information

• Verified date: February 2016
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: January 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer
• Chronic Insomnia

Intervention

Behavioral:
• cognitive behavioral therapy for insomnia (CBTI)
SHUTi program is made up of six, weekly treatment Cores modeled after weekly facetoface(CBTI). Each Core begins by providing a rationale for learning the material, explains main content, homework page with suggestions for improving sleep, and a summarized review of main points. The main content each Core addresses myths about sleep, indepth information about topics, vignettes, and quizzes to evaluate users learning in an interactive. As well as being interactive, SHUTi allows for personalization.Modifications are made to sleep recommendations based in sleep diary data and individually set treatment goals. The cores include Overview, Sleep Behavior Core, Sleep Behavior Core 2, Sleep Education Core, Sleep Thoughts Core, and Problem Prevention Core. Each Core takes approximately 45 to 60 minutes to complete. Cores are presented one at a time; next Core becomes available to users a week after they complete one Core.
• Waitlist control condition
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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Massey Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the efficacy of a CBT-I intervention that improves sleep and quality of life outcomes during cancer treatment.	CBT-I is a cognitive behavioral therapy for insomnia. 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.	1 year	No
Secondary	To assess the feasibility of a CBT--I intervention among newly diagnosed cancer patients.		1 year	No
Secondary	To assess the acceptability of a CBT--I intervention among newly diagnosed cancer patients.		1 year	No