Clinical trial · Observational
A Survey of Sleep Problems in Survivors of Breast Cancer
NCT00587340CI-TRIAL-00005502completedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to gain greater understanding of the problems breast cancer survivors experience related to difficulty sleeping and insomnia. Poor sleep can affect a person's mood, increase feelings of fatigue, as well as pain. A greater knowledge and understanding of sleep disturbances can lead to more effective treatment of sleep problems and significantly improve quality of life.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- 1
- description
- 15 subjects with subjective sleep disturbance based on the Pittsburgh Sleep Quality Index
- label
- 2
- description
- mild/moderate subjective sleep disturbance (insomnia) based on the Pittsburgh Sleep Quality Index
- label
- 3
- description
- severe subjective sleep disturbance (insomnia)based on the Pittsburgh Sleep Quality Index
Primary outcomes (2)
- measure
- Determine the prevalence of cancer-related insomnia in women surviving breast cancer (Stage I, II, & III) who are at least one year, but not more than 10 years posttreatment & to study its deleterious impact on qol
- timeFrame
- 2 years
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Subject Inclusion Criteria for Questionnaire Portion of Study * Women with a diagnosis of Stage I, II, or III breast cancer who are one year posttreatment, but not more than 10 years post-treatment (surgery, chemotherapy, and/or radiation) prior to entrance into the study. Use of biological and/or hormonal therapy is acceptable. * Greater than 18 years of age. * Able to speak and read English. Exclusion Criteria: Subject Exclusion Criteria for Questionnaire Portion of Study •Evidence of acute or chronic encephalopathy or psychiatric disease severe enough to compromise data collection. Exclusion Criteria for Sleep Lab Study •Women who are unable or unwilling to avoid alcohol, caffeine consumption or cigarette smoking as of 3 p.m. on the day of the sleep study.
References
Publications (0)
Data not yet available
No reference posted for this study.