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Brief Behavioral Intervention for Insomnia During Chemotherapy

NCT02165839 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2020-12-03

Study results available
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Summary

PRIMARY OBJECTIVE(S):

To evaluate the efficacy of the Brief Behavioral Therapy for Insomnia (BBT-I) in treating insomnia among breast cancer patients receiving chemotherapy.

SECONDARY OBJECTIVE(S):

* To evaluate the efficacy of the BBT-I in treating cancer-related symptoms such as cancer-related fatigue and cognitive difficulties in breast cancer patients receiving chemotherapy.
* To examine potential moderators and mediators of BBT-I intervention effects on insomnia, cognitive difficulties, and fatigue. In particular, we are interested in age, depression and anxiety and side effects (hot flashes) as potential moderators of the intervention effects as well as evaluating modifiable behavioral and physiological mechanisms as hypothesized mediators

Conditions

Interventions

BEHAVIORAL

Brief Behavioral Therapy for Insomnia (BBT-I)

BEHAVIORAL

Healthy Eating Education Learning (HEAL)

Sponsors & Collaborators

Principal Investigators

  • Oxana Palesh, PhD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2019-06-19
Completion
2020-06-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02165839 on ClinicalTrials.gov