A Survey of Sleep Problems in Survivors of Breast Cancer
1 other identifier
observational
256
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2006
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 21, 2007
CompletedFirst Posted
Study publicly available on registry
January 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedSeptember 19, 2011
September 1, 2011
5.1 years
December 21, 2007
September 16, 2011
Conditions
Outcome Measures
Primary Outcomes (2)
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
2 years
To describe the underlying physiology and nature of sleep disturbances in this cohort of women by performing sleep lab studies with a subset of the sample
2 years
Secondary Outcomes (2)
To survey the medical, demographic and psychosocial correlates of cancer-related insomnia in this cohort of women to identify subgroups with potentially differing etiologies and associated symptoms to help plan relevant intervention studies
2 Years
To preliminarily describe correlations between subgroups and sleep disturbances documented in the sleep lab studies
2 years
Study Arms (3)
1
15 subjects with subjective sleep disturbance based on the Pittsburgh Sleep Quality Index
2
mild/moderate subjective sleep disturbance (insomnia) based on the Pittsburgh Sleep Quality Index
3
severe subjective sleep disturbance (insomnia)based on the Pittsburgh Sleep Quality Index
Eligibility Criteria
Breast cancer Patients
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centerlead
- New York Presbyterian Hospitalcollaborator
- Rockefeller Universitycollaborator
- Vanderbilt Universitycollaborator
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven Passik, PhD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2007
First Posted
January 7, 2008
Study Start
August 1, 2006
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
September 19, 2011
Record last verified: 2011-09