search
Back to results

Cognitive Behavioral Therapy (CBT)-Insomnia for Lung Cancer

Primary Purpose

Chronic Insomnia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive behavioral therapy for insomnia
Healthy eating control
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Insomnia focused on measuring lung cancer survivors, insomnia treatment, cognitive behavioral therapy

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • SUNY University at Buffalo
  • Roswell Park Cancer Institute Thoracic Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Healthy eating control

Cognitive behavioral therapy

Arm Description

Healthy eating control involves healthy eating content delivered in a 90 minute group session with two follow up phone calls.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 25, 2013
Last Updated
February 8, 2023
Sponsor
State University of New York at Buffalo
Collaborators
National Institute of Nursing Research (NINR)
search

1. Study Identification

Unique Protocol Identification Number
NCT02121652
Brief Title
Cognitive Behavioral Therapy (CBT)-Insomnia for Lung Cancer
Official Title
Translating CBT-Insomnia for Lung Cancer Into Practice: A RCT
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Insomnia
Keywords
lung cancer survivors, insomnia treatment, cognitive behavioral therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy eating control
Arm Type
Active Comparator
Arm Description
Healthy eating control involves healthy eating content delivered in a 90 minute group session with two follow up phone calls.
Arm Title
Cognitive behavioral therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy for insomnia
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Healthy eating control
Intervention Description
Healthy eating control involves healthy eating content delivered in a 90 minute group session with two follow up phone calls.
Primary Outcome Measure Information:
Title
Sleep Efficiency
Description
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.
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Dickerson, RN, PhD
Organizational Affiliation
SUNY University at Buffalo School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
SUNY University at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States
Facility Name
Roswell Park Cancer Institute Thoracic Clinic
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data have been prepared for sharing with other investigators. All collected individual participant data (IPD) can be accessed at our data repository.
IPD Sharing Time Frame
Data will be made available one year after publication of the study findings manuscript.
IPD Sharing Access Criteria
IPD will be publicly available to the public via a data repository.
Citations:
PubMed Identifier
17326546
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.
Results Reference
background
PubMed Identifier
12683477
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.
Results Reference
background
PubMed Identifier
16777060
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.
Results Reference
background
PubMed Identifier
18591549
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.
Results Reference
background
PubMed Identifier
16858458
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.
Results Reference
background
PubMed Identifier
17352006
Citation
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.
Results Reference
background
PubMed Identifier
23989018
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.
Results Reference
background
PubMed Identifier
31672070
Citation
Dean GE, Weiss C, Jungquist CR, Klimpt ML, Alameri R, Ziegler PA, Steinbrenner LM, Dexter EU, Dhillon SS, Lucke JF, Dickerson SS. Nurse-Delivered Brief Behavioral Treatment for Insomnia in Lung Cancer Survivors: A Pilot RCT. Behav Sleep Med. 2020 Nov-Dec;18(6):774-786. doi: 10.1080/15402002.2019.1685523. Epub 2019 Oct 31.
Results Reference
derived

Learn more about this trial

Cognitive Behavioral Therapy (CBT)-Insomnia for Lung Cancer

We'll reach out to this number within 24 hrs