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Brief Behavioral Treatment for Insomnia in Cancer Survivors

Primary Purpose

Chronic Insomnia

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief behavioral treatment for insomnia
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Insomnia focused on measuring Cancer Survivors, Brief Behavioral Treatment, Older Adults, Attention Control, Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University at Buffalo
  • Roswell Park Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Behavioral: Brief behavioral treatment for insomnia

Behavioral: Healthy eating control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Insomnia Severity Index (ISI)
One month after the intervention, experimental group mean ISI will be compared to control group mean ISI.

Secondary Outcome Measures

Full Information

First Posted
January 14, 2019
Last Updated
May 11, 2023
Sponsor
State University of New York at Buffalo
Collaborators
Roswell Park Cancer Institute, National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT03810365
Brief Title
Brief Behavioral Treatment for Insomnia in Cancer Survivors
Official Title
Efficacy of Nurse-Delivered Brief Behavioral Treatment to Self-Manage Insomnia in Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 6, 2019 (Actual)
Primary Completion Date
October 30, 2022 (Actual)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
Collaborators
Roswell Park Cancer Institute, National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Insomnia
Keywords
Cancer Survivors, Brief Behavioral Treatment, Older Adults, Attention Control, Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral: Brief behavioral treatment for insomnia
Arm Type
Experimental
Arm Description
Brief behavioral treatment for insomnia includes 45 minute individual intervention with two follow up phone calls.
Arm Title
Behavioral: Healthy eating control
Arm Type
Active Comparator
Arm Description
Healthy eating control involves a 45 minute individual session with two follow up phone calls.
Intervention Type
Behavioral
Intervention Name(s)
Brief behavioral treatment for insomnia
Other Intervention Name(s)
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.
Intervention Description
Healthy eating control involves healthy eating content with 1 month 3 month 12 month follow-up visits.
Primary Outcome Measure Information:
Title
Insomnia Severity Index (ISI)
Description
One month after the intervention, experimental group mean ISI will be compared to control group mean ISI.
Time Frame
One month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne S. Dickerson, PhD
Organizational Affiliation
University at Buffalo, School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
University at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States
Facility Name
Roswell Park Comprehensive Cancer Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36182027
Citation
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.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/17326546?dopt=Abstract
Description
Dose-response effects of cognitive-behavioral insomnia therapy: a randomized clinical trial.
URL
http://www.ncbi.nlm.nih.gov/pubmed/12683477?dopt=Abstract
Description
A primary care "friendly" cognitive behavioral insomnia therapy.
URL
http://www.ncbi.nlm.nih.gov/pubmed/16777060?dopt=Abstract
Description
Effects of a brief behavioral treatment for PTSD-related sleep disturbances: a pilot study.
URL
http://www.ncbi.nlm.nih.gov/pubmed/18591549?dopt=Abstract
Description
Randomized controlled clinical effectiveness trial of cognitive behavior therapy compared with treatment as usual for persistent insomnia in patients with cancer.
URL
http://www.ncbi.nlm.nih.gov/pubmed/17352006?dopt=Abstract
Description
How to provide insomnia interventions to people with cancer: insights from patients.

Learn more about this trial

Brief Behavioral Treatment for Insomnia in Cancer Survivors

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