Brief Behavioral Therapy in Improving Sleep Disorders in Patients With Stage I-III Breast Cancer Undergoing Chemotherapy

NCT02002533 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2019-06-05

Study results available
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Summary

This randomized phase II trial studies how well brief behavioral therapy works in improving sleep disorders in patients with stage I-III breast cancer undergoing chemotherapy. Sleep disorder counseling may reduce fatigue and insomnia as well as improve the well-being and quality of life in patients with breast cancer who are undergoing chemotherapy.

Conditions

  • Sleep Disorder
  • Stage IA Breast Cancer
  • Stage IB Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer

Interventions

BEHAVIORAL

Brief Behavioral Therapy

Undergo BBT intervention

BEHAVIORAL

Telephone-Based Intervention

Undergo BBT intervention

OTHER

Educational Intervention

Undergo HEAL

BEHAVIORAL

Telephone-Based Intervention

Undergo HEAL

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Stanford University

    collaborator OTHER
  • Gary Morrow

    lead OTHER

Principal Investigators

  • Oxana Palesh · University of Rochester NCORP Research Base

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-03
Primary Completion
2016-12-16
Completion
2016-12-16

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT02002533 on ClinicalTrials.gov