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Prophylactic Treatment of Sleep/Fatigue Before and During Chemotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sonia Ancoli-Israel, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01542983
First received: February 26, 2012
Last updated: February 5, 2013
Last verified: February 2013
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Feasibility of Prophylactic Treatment of Sleep/Fatigue Before and During Chemotherapy for Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • fatigue [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change in fatigue from pre-chemotherapy to post cycle 4 chemotherapy


Secondary Outcome Measures:
  • sleep [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 85 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Sonia Ancoli-Israel, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01542983     History of Changes
Other Study ID Numbers: 120108
Study First Received: February 26, 2012
Last Updated: February 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on June 17, 2013