NCT02121652

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 23, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
6.6 years until next milestone

Results Posted

Study results publicly available

March 7, 2023

Completed
Last Updated

March 7, 2023

Status Verified

February 1, 2023

Enrollment Period

2.3 years

First QC Date

October 25, 2013

Results QC Date

June 20, 2022

Last Update Submit

February 8, 2023

Conditions

Chronic Insomnia

Keywords

lung cancer survivorsinsomnia treatmentcognitive behavioral therapy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Healthy eating control

ACTIVE COMPARATOR

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

Behavioral: Healthy eating control

Cognitive behavioral therapy

EXPERIMENTAL

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.

Behavioral: Cognitive behavioral therapy for insomnia

Interventions

Cognitive behavioral therapy for insomniaBEHAVIORAL

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.

Cognitive behavioral therapy
Healthy eating controlBEHAVIORAL

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

Healthy eating control

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Other preexisting sleep disorders
  • Unstable medical illnesses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

SUNY University at Buffalo

Buffalo, New York, 14214, United States

Location

Roswell Park Cancer Institute Thoracic Clinic

Buffalo, New York, 14263, United States

Location

Related Publications (9)

  • 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.

    PMID: 17326546BACKGROUND

  • 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.

    PMID: 12683477BACKGROUND

  • 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.

    PMID: 16777060BACKGROUND

  • 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.

    PMID: 18591549BACKGROUND

  • 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.

    PMID: 16858458BACKGROUND

  • 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.

    PMID: 17352006BACKGROUND

  • 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.

    PMID: 23989018BACKGROUND

  • Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.

    PMID: 41170811DERIVED

  • 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.

    PMID: 31672070DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Suzanne S. Dickerson
Organization
University at Buffalo School of Nursing
sdickers@buffalo.edu
716-829-3254

Study Officials

  • Suzanne Dickerson, RN, PhD

    SUNY University at Buffalo School of Nursing

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 25, 2013

First Posted

April 23, 2014

Study Start

April 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

March 7, 2023

Results First Posted

March 7, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

Data have been prepared for sharing with other investigators. All collected individual participant data (IPD) can be accessed at our data repository.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will be made available one year after publication of the study findings manuscript.
Access Criteria
IPD will be publicly available to the public via a data repository.

Locations

US(2)