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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer

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.

• Study Type: Observational
• Enrollment (Actual): 256

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Breast cancer Patients

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Vanderbilt University; New York Presbyterian Hospital; Rockefeller University
• Investigators: Principal Investigator: Steven Passik, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan-Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: December 21, 2007
• First Submitted That Met QC Criteria: December 21, 2007
• First Posted (Estimate): January 7, 2008

Study Record Updates

• Last Update Posted (Estimate): September 19, 2011
• Last Update Submitted That Met QC Criteria: September 16, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Skin Diseases; Neoplasms; Sleep Wake Disorders; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Dyssomnias; Parasomnias
• Other Study ID Numbers: 06-071