Brief Behavioral Treatment for Insomnia in Cancer Survivors

State University of New York at Buffalo132 enrolled

Overview

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

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

132

Conditions

Chronic Insomnia

Interventions

Brief behavioral treatment for insomniaBEHAVIORAL

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 ControlBEHAVIORAL

Healthy eating control involves healthy eating content with 1 month for primary outcome followed by 3 month and 12 month follow-up visits.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

University at Buffalo

Buffalo, New York, United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: one month

Data from ClinicalTrials.gov

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