Brief Behavioral Treatment for Insomnia in Cancer Survivors

Chronic Insomnia Clinical Trial

Official title:

Efficacy of Nurse-Delivered Brief Behavioral Treatment to Self-Manage Insomnia in Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03810365
• Other study ID #: STUDY00002898
• Secondary ID: 1R01NR018215
• Status: Completed
• Phase: N/A
• Start date: June 6, 2019
• Est. completion date: November 1, 2023

Study information

• Verified date: November 2023
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: November 1, 2023
• Est. primary completion date: November 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Roswell Park Comprehensive Cancer Center	Buffalo	New York
United States	University at Buffalo	Buffalo	New York

Sponsors (3)

Lead Sponsor	Collaborator
State University of New York at Buffalo	National Institute of Nursing Research (NINR), Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insomnia Severity Index	One month after the intervention, experimental group mean for Insomnia Severity Index will be compared to control group mean Insomnia Severity Index.; The Insomnia Severity Index is a self report brief screening tool with seven items that asks respondents to rate the nature and symptoms of their sleep problems and the degree to which insomnia interferes with daily functioning and overall distress created by sleep problems using a likert type scale Scores between 0-7 have no clinically significant insomnia. Scores between 8-14 have sub threshold insomnia. Scores between 15-21 have moderate clinical insomnia. Scores between 22-28 have severe clinical insomnia.	one month

External Links

•   A primary care "friendly" cognitive behavioral insomnia therapy.
•   Dose-response effects of cognitive-behavioral insomnia therapy: a randomized clinical trial.
•   Effects of a brief behavioral treatment for PTSD-related sleep disturbances: a pilot study.
•   How to provide insomnia interventions to people with cancer: insights from patients.
•   Randomized controlled clinical effectiveness trial of cognitive behavior therapy compared with treatment as usual for persistent insomnia in patients with cancer.