NCT00505544

Brief Summary

Objectives: Primary Objectives:

  1. 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. 2.To evaluate the construct validity of the BSDS through exploratory factor analysis.
  3. 3.To examine possible predictors of sleep disturbance.
  4. 4.To evaluate the reliability of the BSDS using Cronbach's coefficient alpha and test-retest reliability.
  5. 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. 6.To evaluate the psychometric properties of the BSDS in a sample of community dwelling adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
459

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2005

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 23, 2007

Completed
15 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2022

Completed
Last Updated

July 13, 2022

Status Verified

July 1, 2022

Enrollment Period

17 years

First QC Date

July 19, 2007

Last Update Submit

July 12, 2022

Conditions

Advanced Cancer

Keywords

Advanced CancerQuestionnaireSurveySleep DisturbanceSleep Quality

Outcome Measures

Primary Outcomes (1)

  • Sensitivity of Brief Sleep Disturbance Scale (BSDS)

    Administering to same group prior to treatment with a regimen associated with sleep disturbance, during 4 weeks of treatment, and upon completion of treatment.

Study Arms (2)

Questionnaire

Questionnaires that ask about your sleep, symptoms, and mood.

Behavioral: Questionnaire

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: QuestionnaireDevice: Actigraph

Interventions

QuestionnaireBEHAVIORAL

Questionnaires that ask about your sleep, symptoms, and mood.

Also known as: Survey
QuestionnaireQuestionnaire + Actigraphs
ActigraphDEVICE

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

Questionnaire + Actigraphs

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Cannot understand the intent of the study.
  • Patient feels too ill to complete the surveys.
  • Refuses to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lyndon Baines Johnson General Hospital

Houston, Texas, 77030, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

ParasomniasSleep Initiation and Maintenance Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental DisordersSleep Disorders, IntrinsicDyssomnias

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Xin S. Wang, MD,MPH

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2007

First Posted

July 23, 2007

Study Start

August 1, 2005

Primary Completion

July 11, 2022

Study Completion

July 11, 2022

Last Updated

July 13, 2022

Record last verified: 2022-07

Locations

US(2)