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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

Tracking Information
First Submitted Date  ICMJE January 14, 2019
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date January 25, 2019
Estimated Study Start Date  ICMJE April 15, 2019
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 16, 2019)
Sleep Diary Sleep Efficiency improvement to 85% [ Time Frame: 1 month ] [ Time Frame: One month ]
One month after the intervention, sleep diary sleep efficiency will be compared to pre-intervention sleep efficiency.
Change History Complete list of historical versions of study NCT03810365 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Brief Behavioral Treatment for Insomnia in Cancer Survivors
Official Title  ICMJE Efficacy of Nurse-Delivered Brief Behavioral Treatment to Self-Manage Insomnia in Cancer Survivors
Brief Summary The purpose is to determine whether brief behavioral treatment is effective for insomnia in cancer survivors.
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Insomnia
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Behavioral: Brief behavioral treatment for insomnia
    Brief behavioral treatment for insomnia includes 45 minute individual intervention with two follow up phone calls.
    Intervention: Behavioral: Brief behavioral treatment for insomnia
  • Active Comparator: Behavioral: Healthy eating control
    Healthy eating control involves a 45 minute individual session with two follow up phone calls.
    Intervention: Behavioral: Brief behavioral treatment for insomnia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 16, 2019)
158
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2023
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Donna A Tyrpak, MS, RN, ANP 716-829-2140 tyrpak@buffalo.edu
Contact: Grace E Dean, PhD 716-829-3235 gdean@buffalo.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03810365
Other Study ID Numbers  ICMJE STUDY00002898
1R01NR018215 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Not available
Responsible Party Grace Dean, State University of New York at Buffalo
Study Sponsor  ICMJE State University of New York at Buffalo
Collaborators  ICMJE
  • Roswell Park Cancer Institute
  • National Institute of Nursing Research (NINR)
Investigators  ICMJE Not Provided
PRS Account State University of New York at Buffalo
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP