Brief Behavioral Treatment for Insomnia in Cancer Survivors

Not Applicable

Completed

• Conditions: Chronic Insomnia
• Interventions: Behavioral: Healthy Eating Control; Behavioral: Brief behavioral treatment for insomnia

• Registration Number: NCT03810365
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-01-14
• Study First Submitted QC: 2019-01-16
• Study First Posted: 2019-01-18
• Study Start: 2019-06-06
• Primary Completion: 2022-11-17
• Results First Submitted: 2023-09-26
• Study Completion: 2023-11-01
• Results First Submitted QC: 2023-11-28
• Results First Posted: 2023-11-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-07
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioral: Healthy eating control	Healthy Eating Control	Healthy eating control involves a 45 minute individual session with two follow up phone calls.
Behavioral: Brief behavioral treatment for insomnia	Brief behavioral treatment for insomnia	Brief behavioral treatment for insomnia includes 45 minute individual intervention with two follow up phone calls.

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index	one month	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.

Trial Locations

Locations (2)

University at Buffalo; 🇺🇸 Buffalo, New York, United States

Roswell Park Comprehensive Cancer Center; 🇺🇸 Buffalo, New York, United States