A Survey of Sleep Problems in Survivors of Breast Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT00587340

06-071

Details and patient eligibility

About

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.

Full 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.

Enrollment: 256 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

256 participants in 3 patient groups

1

Description:

15 subjects with subjective sleep disturbance based on the Pittsburgh Sleep Quality Index

2

Description:

mild/moderate subjective sleep disturbance (insomnia) based on the Pittsburgh Sleep Quality Index

3

Description:

severe subjective sleep disturbance (insomnia)based on the Pittsburgh Sleep Quality Index