A Survey of Sleep Problems in Survivors of Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
New York Presbyterian Hospital
Rockefeller University
Vanderbilt University
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00587340
First received: December 21, 2007
Last updated: September 16, 2011
Last verified: September 2011
  Purpose

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.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Survey of Sleep Problems in Survivors of Breast Cancer

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
  • To preliminarily describe correlations between subgroups and sleep disturbances documented in the sleep lab studies [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 256
Study Start Date: August 2006
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Breast cancer Patients

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00587340

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
New York Presbyterian Hospital
Rockefeller University
Vanderbilt University
Investigators
Principal Investigator: Steven Passik, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00587340     History of Changes
Other Study ID Numbers: 06-071
Study First Received: December 21, 2007
Last Updated: September 16, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Dyssomnias
Parasomnias
Sleep Disorders
Breast Diseases
Mental Disorders
Neoplasms
Neoplasms by Site
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Skin Diseases

ClinicalTrials.gov processed this record on October 20, 2014