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Completed

NCT Number: NCT00587340

A Survey of Sleep Problems in Survivors of Breast Cancer

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. To preliminarily describe correlations between subgroups and sleep disturbances documented in the sleep lab studies

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • New York Presbyterian Hospital
  • Rockefeller University
  • Vanderbilt University

Registry information

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Jan 7, 2008
Registry last updated
Sep 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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