A Survey of Sleep Problems in Survivors of Breast Cancer
18 Years
N/A
Female
Breast Cancer
Trial Information
A Survey of Sleep Problems in Survivors of Breast Cancer
Individuals who consent to participate in this study will be asked to complete a battery of
questionnaires that will take approximately 1 hour. Based on answers they give to the
questionnaires, 45 patients will be asked to participate in a sleep study done at a sleep
lab.
If you choose to take part, then you will be asked to do the following:
Spend approximately 1 hour answering questionnaires either at the breast cancer center with
a research assistant, at home on the phone with a research assistant, or by completing the
questionnaires at home and returning them by mail. You will only be asked to complete
questionnaires one time. The questionnaires will ask you questions about your:
- Past medical history
- Demographics
- Sleep quality
- Sleep habits
- Energy level, pain, daytime sedation
- Quality of life
- Menopausal symptoms
- Depression
- Fears
If you are then selected to participate in the sleep study, further information will be
provided for you.
After you are finished with the questionnaires, the research assistant will provide you with
any necessary further information and feedback. The research assistant will also be able to
put you in contact with a study doctor should you require any further assistance. After you
are finished with the study, the study doctor may contact you for clarification of your
answer on a question, or for an answer if you have by any chance missed a question.
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.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome 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
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Steven Passik, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
06-071
NCT ID:
NCT00587340
Start Date:
August 2006
Completion Date:
September 2011
Related Keywords:
- Breast Cancer
- Breast Neoplasms
- Dyssomnias
- Sleep Disorders
- Parasomnias
Name | Location |
|---|---|
| Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
