Cognitive Behavioral Therapy (CBT)-Insomnia for Lung Cancer

NCT ID: NCT02121652

Last Updated: 2023-03-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Chronic Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Healthy eating control

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

Group Type ACTIVE_COMPARATOR

Healthy eating control

Intervention Type BEHAVIORAL

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

Cognitive behavioral therapy

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.

Group Type EXPERIMENTAL

Cognitive behavioral therapy for insomnia

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Healthy eating control

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

State University of New York at Buffalo

OTHER

Sponsor Role lead

Responsible Party

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Suzanne Dickerson

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Suzanne Dickerson, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

SUNY University at Buffalo School of Nursing

Locations

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SUNY University at Buffalo

Buffalo, New York, United States

Site Status

Roswell Park Cancer Institute Thoracic Clinic

Buffalo, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 17326546 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12683477 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16777060 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18591549 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16858458 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17352006 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23989018 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31672070 (View on PubMed)

Other Identifiers

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517176-1

Identifier Type: REGISTRY

Identifier Source: secondary_id

1R15NR013779-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

517176-3

Identifier Type: -

Identifier Source: org_study_id

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