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Prophylactic Treatment of Sleep/Fatigue Before and During Chemotherapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01542983
First Posted: March 2, 2012
Last Update Posted: February 6, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sonia Ancoli-Israel, University of California, San Diego
  Purpose
Women with breast cancer complain of poor sleep and fatigue during chemotherapy which affect their mood, their memory and their quality of life. The investigators are testing whether it is feasible to treat the poor sleep and fatigue with behavioral treatments, before the start of chemotherapy and whether improving sleep and fatigue will also improve mood, memory and quality of life.

Condition Intervention
Stage, Breast Cancer Behavioral: Brief behavioral treatment for insomnia and bright light Behavioral: treatment as usual

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Feasibility of Prophylactic Treatment of Sleep/Fatigue Before and During Chemotherapy for Breast Cancer

Resource links provided by NLM:


Further study details as provided by Sonia Ancoli-Israel, University of California, San Diego:

Primary Outcome Measures:
  • fatigue [ Time Frame: 12 weeks ]
    Change in fatigue from pre-chemotherapy to post cycle 4 chemotherapy


Secondary Outcome Measures:
  • sleep [ Time Frame: 12 weeks ]
    Changes in sleep and sleep quality will be assessed from pre-chemotherapy to post-cycle 4 chemotherapy


Enrollment: 10
Study Start Date: March 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment-as-usual
Treatment as usual for fatigue and insomnia
Behavioral: treatment as usual
Standard treatment for fatigue and insomnia
Active Comparator: Behavioral treatment
Brief behavioral treatment for insomnia and bright light Light and BBTI combined treatment for insomnia and fatigue
Behavioral: Brief behavioral treatment for insomnia and bright light
daily bright light exposure; 2 sessions for insomnia

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • stage I-III breast cancer referred for chemotherapy
  • English speaking
  • over age 18

Exclusion Criteria:

  1. Pregnancy (by self-report; poor sleep and fatigue are sometimes associated with pregnancy);
  2. Metastatic or unresectable breast cancer;
  3. Patients who have been told they have sleep apnea, restless legs or periodic limb movements in sleep whether or not they are currently treated;
  4. History of bipolar disorder or history of mania;
  5. Current diagnosis of psychotic disorder;
  6. Blindness or other physical or psychological impairments which would limit participation;
  7. Shift workers;
  8. Women with infants who still disturb the mother's sleep.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01542983


Locations
United States, California
Moores UCSD Cancer Center
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Sonia Ancoli-Israel, PhD UCSD
  More Information

Responsible Party: Sonia Ancoli-Israel, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01542983     History of Changes
Other Study ID Numbers: 120108
First Submitted: February 26, 2012
First Posted: March 2, 2012
Last Update Posted: February 6, 2013
Last Verified: February 2013

Keywords provided by Sonia Ancoli-Israel, University of California, San Diego:
breast cancer
bright light
insomnia
fatigue

Additional relevant MeSH terms:
Breast Neoplasms
Fatigue
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms