Brief Behavioral Treatment for Insomnia in Cancer Survivors

NCT ID: NCT03810365

Last Updated: 2024-07-03

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

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-06

Study Completion Date

2023-11-01

Brief Summary

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The purpose is to determine whether brief behavioral treatment is effective for insomnia in cancer survivors.

Detailed Description

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A randomized controlled clinical trial will be used to test the efficacy of this brief behavioral treatment compared to attention control on sleep, mood, functional, status and quality of life and determine predictors for efficacy of Brief Behavioral Treatment for Insomnia (BBTI).

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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Behavioral: Brief behavioral treatment for insomnia

Brief behavioral treatment for insomnia includes 45 minute individual intervention with two follow up phone calls.

Group Type EXPERIMENTAL

Brief behavioral treatment for insomnia

Intervention Type BEHAVIORAL

Brief Behavioral Treatment for Insomnia includes content on sleep restriction, stimulus control, and sleep hygiene content with 1 month for primary outcome followed by 3 month 12 month follow-up visits.

Behavioral: Healthy eating control

Healthy eating control involves a 45 minute individual session with two follow up phone calls.

Group Type ACTIVE_COMPARATOR

Healthy Eating Control

Intervention Type BEHAVIORAL

Healthy eating control involves healthy eating content with 1 month for primary outcome followed by 3 month and 12 month follow-up visits.

Interventions

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Brief behavioral treatment for insomnia

Brief Behavioral Treatment for Insomnia includes content on sleep restriction, stimulus control, and sleep hygiene content with 1 month for primary outcome followed by 3 month 12 month follow-up visits.

Intervention Type BEHAVIORAL

Healthy Eating Control

Healthy eating control involves healthy eating content with 1 month for primary outcome followed by 3 month and 12 month follow-up visits.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* \> or = 4 weeks from surgery for cancer treatment; chemotherapy and/or radiation therapy; no wait for hormone therapy or targeted treatment for stage I, II, or III: breast, colorectal, prostate, lung cancer
* chronic insomnia

Exclusion Criteria

* Other preexisting sleep disorders except those with OSA stable on CPAP
* Unstable medical illnesses
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roswell Park Cancer Institute

OTHER

Sponsor Role collaborator

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 S. Dickerson, PhD

Role: PRINCIPAL_INVESTIGATOR

University at Buffalo, School of Nursing

Locations

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University at Buffalo

Buffalo, New York, United States

Site Status

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Site Status

Countries

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United States

References

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Kwon M, Zhu J, Wilding GE, Larkin K, Gehrman PR, Dickerson SS. Health-related quality of life and mental health outcomes among cancer survivors in an insomnia intervention: a randomized controlled trial. Ann Behav Med. 2025 Jan 4;59(1):kaae096. doi: 10.1093/abm/kaae096.

Reference Type DERIVED
PMID: 39887070 (View on PubMed)

Dickerson SS, Kwon M, Wilding GE, Zhu J. Nurse-delivered brief behavioral treatment for insomnia in cancer survivors: a randomized controlled trial. J Cancer Surviv. 2024 Nov 26. doi: 10.1007/s11764-024-01704-1. Online ahead of print.

Reference Type DERIVED
PMID: 39589721 (View on PubMed)

Kwon M, Zhu J, Wilding GE, Dickerson SS, Dean GE. Sleep-wake state discrepancy among cancer survivors with insomnia symptoms. Support Care Cancer. 2023 Dec 4;32(1):2. doi: 10.1007/s00520-023-08177-5.

Reference Type DERIVED
PMID: 38047967 (View on PubMed)

Kwon M, Dickerson SS, Wilding GE, Aquilina AT, Reid M, Dean GE. A nurse-delivered intervention to reduce insomnia in cancer survivors: Study protocol for a randomized-controlled trial. Contemp Clin Trials. 2022 Nov;122:106939. doi: 10.1016/j.cct.2022.106939. Epub 2022 Sep 28.

Reference Type DERIVED
PMID: 36182027 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/17326546?dopt=Abstract

Dose-response effects of cognitive-behavioral insomnia therapy: a randomized clinical trial.

http://www.ncbi.nlm.nih.gov/pubmed/12683477?dopt=Abstract

A primary care "friendly" cognitive behavioral insomnia therapy.

http://www.ncbi.nlm.nih.gov/pubmed/16777060?dopt=Abstract

Effects of a brief behavioral treatment for PTSD-related sleep disturbances: a pilot study.

http://www.ncbi.nlm.nih.gov/pubmed/18591549?dopt=Abstract

Randomized controlled clinical effectiveness trial of cognitive behavior therapy compared with treatment as usual for persistent insomnia in patients with cancer.

http://www.ncbi.nlm.nih.gov/pubmed/17352006?dopt=Abstract

How to provide insomnia interventions to people with cancer: insights from patients.

Other Identifiers

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1R01NR018215

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00002898

Identifier Type: -

Identifier Source: org_study_id

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