Cognitive Behavioral Therapy (CBT)-Insomnia for Lung Cancer

Chronic Insomnia Clinical Trial

Official title:

Translating CBT-Insomnia for Lung Cancer Into Practice: A RCT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02121652
• Other study ID #: 517176-3
• Secondary ID: 517176-11R15NR01
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: August 2016

Study information

• Verified date: February 2023
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether cognitive behavioral therapy (CBT) is effective for insomnia in lung cancer survivors.

Description:

A randomized controlled clinical trial will be used to test the efficacy of this brief CBT-I compared to attention control on sleep, mood, functional status and quality of life in lung cancer survivors and evaluate the feasibility of translating an evidence-based CBT-I into the clinical setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 6 weeks from surgery for stage 1 or 2 Non Small Cell Lung Cancer

• chronic insomnia

Exclusion Criteria:

• Other preexisting sleep disorders

• Unstable medical illnesses

Related Conditions & MeSH terms

• Chronic Insomnia
• Lung Neoplasms
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Cognitive behavioral therapy for insomnia
Cognitive behavioral therapy for insomnia includes content on sleep restriction, stimulus control, relaxation, cognitive restructuring and sleep hygiene content delivered in a 90 minute group intervention with two follow up phone calls.
• Healthy eating control
Healthy eating control involves healthy eating content delivered in a 90 minute group session with two follow up phone calls.

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute Thoracic Clinic	Buffalo	New York
United States	SUNY University at Buffalo	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York at Buffalo	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & Publications (7)

Davidson JR, Feldman-Stewart D, Brennenstuhl S, Ram S. How to provide insomnia interventions to people with cancer: insights from patients. Psychooncology. 2007 Nov;16(11):1028-38. doi: 10.1002/pon.1183. — View Citation

Dean GE, Redeker NS, Wang YJ, Rogers AE, Dickerson SS, Steinbrenner LM, Gooneratne NS. Sleep, mood, and quality of life in patients receiving treatment for lung cancer. Oncol Nurs Forum. 2013 Sep;40(5):441-51. doi: 10.1188/13.ONF.441-451. — View Citation

Edinger JD, Sampson WS. A primary care "friendly" cognitive behavioral insomnia therapy. Sleep. 2003 Mar 15;26(2):177-82. doi: 10.1093/sleep/26.2.177. — View Citation

Edinger JD, Wohlgemuth WK, Radtke RA, Coffman CJ, Carney CE. Dose-response effects of cognitive-behavioral insomnia therapy: a randomized clinical trial. Sleep. 2007 Feb;30(2):203-12. doi: 10.1093/sleep/30.2.203. — View Citation

Espie CA, Fleming L, Cassidy J, Samuel L, Taylor LM, White CA, Douglas NJ, Engleman HM, Kelly HL, Paul J. Randomized controlled clinical effectiveness trial of cognitive behavior therapy compared with treatment as usual for persistent insomnia in patients with cancer. J Clin Oncol. 2008 Oct 1;26(28):4651-8. doi: 10.1200/JCO.2007.13.9006. Epub 2008 Jun 30. Erratum In: J Clin Oncol. 2010 Jul 1;28(19):3205. — View Citation

Germain A, Shear MK, Hall M, Buysse DJ. Effects of a brief behavioral treatment for PTSD-related sleep disturbances: a pilot study. Behav Res Ther. 2007 Mar;45(3):627-32. doi: 10.1016/j.brat.2006.04.009. Epub 2006 Jun 14. — View Citation

Vena C, Parker K, Allen R, Bliwise D, Jain S, Kimble L. Sleep-wake disturbances and quality of life in patients with advanced lung cancer. Oncol Nurs Forum. 2006 Jul 1;33(4):761-9. doi: 10.1188/06.ONF.761-769. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep Efficiency	Sleep Efficiency > 85% measured with a seven-day sleep diary. The score is calculated based on participants' recording of time asleep (minutes) divided by time in bed (minutes).; Sleep Efficiency greater than or equal to 85% indicates good sleep quality, and values less than 85% indicate poor sleep quality.	5 weeks