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Measuring Sleep Disturbance Among Cancer Patients

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.
 
ClinicalTrials.gov Identifier: NCT00505544
Recruitment Status : Active, not recruiting
First Posted : July 23, 2007
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

Objectives:

Primary Objectives:

  1. To establish concurrent criterion-related validity of the Brief Sleep Disturbance Scale (BSDS) by correlating the scale with the Pittsburgh Sleep Quality Index.
  2. To evaluate the construct validity of the BSDS through exploratory factor analysis.
  3. To examine possible predictors of sleep disturbance.
  4. To evaluate the reliability of the BSDS using Cronbach's coefficient alpha and test-retest reliability.
  5. To evaluate the sensitivity of the BSDS by administering it to the same group of patients (n = 60) prior to treatment with a regimen associated with sleep disturbance, during 4 weeks of treatment, and upon completion of treatment.
  6. To evaluate the psychometric properties of the BSDS in a sample of community dwelling adults.

Secondary Objective:

1. To obtain pilot data from a small sample of patients who will wear an actigraph for one week.


Condition or disease Intervention/treatment
Advanced Cancer Behavioral: Questionnaire Device: Actigraph

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Study Type : Observational
Actual Enrollment : 459 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Brief Sleep Disturbance Scale: Measuring Sleep Disturbance Among Cancer Patients
Actual Study Start Date : August 2005
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Group/Cohort Intervention/treatment
Questionnaire
Questionnaires that ask about your sleep, symptoms, and mood.
Behavioral: Questionnaire
Questionnaires that ask about your sleep, symptoms, and mood.
Other Name: Survey

Questionnaire + Actigraphs
Questionnaires that ask about your sleep, symptoms, and mood. Wear actigraph to collect information on activity levels and sleep patterns for one week.
Behavioral: Questionnaire
Questionnaires that ask about your sleep, symptoms, and mood.
Other Name: Survey

Device: Actigraph
Wear actigraph to collect information on activity levels and sleep patterns for one week.




Primary Outcome Measures :
  1. Sensitivity of Brief Sleep Disturbance Scale (BSDS) [ Time Frame: Administering to same group prior to treatment with a regimen associated with sleep disturbance, during 4 weeks of treatment, and upon completion of treatment. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Study participants with a pathological diagnosis of cancer and community dwelling adults who attend a meeting of a designated service organization.
Criteria

Inclusion Criteria:

  1. Outpatient or inpatient receiving evaluation, treatment, or follow-up care at MDACC or a collaborating site.
  2. Has a pathological diagnosis of cancer.
  3. 18 years of age or older.
  4. Able to understand English.
  5. Gives informed consent to participate.
  6. Community sample eligibility: Community dwelling adult who attends a meeting of a designated service organization.
  7. Community sample eligibility: 18 years of age or older
  8. Community sample eligibility: Gives Informed Consent to participate.
  9. Community sample eligibility: Able to understand English.

Exclusion Criteria:

  1. Cannot understand the intent of the study.
  2. Patient feels too ill to complete the surveys.
  3. Refuses to participate.
  4. Community sample exclusion criterion: Unable to complete the surveys.
  5. Community sample exclusion criterion: Refuses to participate.
  6. Community sample exclusion criterion: Cancer diagnosis (past or present).

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): NCT00505544


Locations
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United States, Texas
Lyndon Baines Johnson General Hospital
Houston, Texas, United States, 77030
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Tito Mendoza, BS,MED,MS,PHD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00505544    
Other Study ID Numbers: 2004-0598
First Posted: July 23, 2007    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancer
Questionnaire
Survey
Sleep Disturbance
Sleep Quality
Additional relevant MeSH terms:
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Dyssomnias
Parasomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders