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Trial record 25 of 2219 for:    Symptoms | Parasomnias

Measuring Sleep Disturbance Among Cancer Patients

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ClinicalTrials.gov Identifier: NCT00505544
Recruitment Status : Active, not recruiting
First Posted : July 23, 2007
Last Update Posted : December 5, 2017
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

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 570 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 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Disorders

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. ]


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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
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
Principal Investigator: Tito Mendoza, PHD, MS, MED, BS M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00505544     History of Changes
Other Study ID Numbers: 2004-0598
First Posted: July 23, 2007    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: December 2017

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancer
Questionnaire
Survey
Sleep Disturbance
Sleep Quality

Additional relevant MeSH terms:
Dyssomnias
Sleep Wake Disorders
Parasomnias
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms