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Brief Behavioral Treatment for Insomnia in Cancer Survivors

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ClinicalTrials.gov Identifier: NCT03810365
Recruitment Status : Not yet recruiting
First Posted : January 18, 2019
Last Update Posted : January 25, 2019
Sponsor:
Collaborators:
Roswell Park Cancer Institute
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Grace Dean, State University of New York at Buffalo

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

Condition or disease Intervention/treatment Phase
Chronic Insomnia Behavioral: Brief behavioral treatment for insomnia Not Applicable

Detailed Description:
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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Nurse-Delivered Brief Behavioral Treatment to Self-Manage Insomnia in Cancer Survivors
Estimated Study Start Date : April 15, 2019
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Behavioral: Brief behavioral treatment for insomnia
Brief behavioral treatment for insomnia includes 45 minute individual intervention with two follow up phone calls.
Behavioral: Brief behavioral treatment for insomnia
Healthy eating control involves healthy eating content with 1 month 3 month 12 month follow-up visits.
Other Name: Brief behavioral treatment for insomnia includes content on sleep restriction, stimulus control, and sleep hygiene content with 1 month 3 month 12 month follow-up visits.

Active Comparator: Behavioral: Healthy eating control
Healthy eating control involves a 45 minute individual session with two follow up phone calls.
Behavioral: Brief behavioral treatment for insomnia
Healthy eating control involves healthy eating content with 1 month 3 month 12 month follow-up visits.
Other Name: Brief behavioral treatment for insomnia includes content on sleep restriction, stimulus control, and sleep hygiene content with 1 month 3 month 12 month follow-up visits.




Primary Outcome Measures :
  1. Sleep Diary Sleep Efficiency improvement to 85% [ Time Frame: One month ]
    One month after the intervention, sleep diary sleep efficiency will be compared to pre-intervention sleep efficiency.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • > or = 6 weeks from surgery and > or = 1 year from treatment other than hormonal therapy for stage I, II, or III: breast, colorectal, prostate, lung cancer
  • chronic insomnia

Exclusion Criteria:

  • Other preexisting sleep disorders
  • Unstable medical illnesses

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03810365


Contacts
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Contact: Donna A Tyrpak, MS, RN, ANP 716-829-2140 tyrpak@buffalo.edu
Contact: Grace E Dean, PhD 716-829-3235 gdean@buffalo.edu

Sponsors and Collaborators
State University of New York at Buffalo
Roswell Park Cancer Institute
National Institute of Nursing Research (NINR)

Additional Information:
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Responsible Party: Grace Dean, Associate Professor, State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT03810365     History of Changes
Other Study ID Numbers: STUDY00002898
1R01NR018215 ( U.S. NIH Grant/Contract )
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders