Clinical trial · Observational
Measuring Sleep Disturbance Among Cancer Patients
The Brief Sleep Disturbance Scale: Measuring Sleep Disturbance Among Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Actigraph | Device | — | UNRESOLVED |
| Questionnaire | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Questionnaire
- description
- Questionnaires that ask about your sleep, symptoms, and mood.
- interventionNames
- Behavioral: Questionnaire
- label
- Questionnaire + Actigraphs
- description
- Questionnaires that ask about your sleep, symptoms, and mood. Wear actigraph to collect information on activity levels and sleep patterns for one week.
- interventionNames
- Behavioral: Questionnaire
- Device: Actigraph
Primary outcomes (1)
- measure
- Sensitivity of Brief Sleep Disturbance Scale (BSDS)
- timeFrame
- Administering to same group prior to treatment with a regimen associated with sleep disturbance, during 4 weeks of treatment, and upon completion of treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
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