Measuring Sleep Disturbance Among Cancer Patients

The Brief Sleep Disturbance Scale: Measuring Sleep Disturbance Among Cancer Patients

Objectives:

Primary Objectives:

1. To establish concurrent criterion-related validity of the Brief Sleep Disturbance Scale (BSDS) by correlating the scale with the Pittsburgh Sleep Quality Index.
2. To evaluate the construct validity of the BSDS through exploratory factor analysis.
3. To examine possible predictors of sleep disturbance.
4. To evaluate the reliability of the BSDS using Cronbach's coefficient alpha and test-retest reliability.
5. To evaluate the sensitivity of the BSDS by administering it to the same group of patients (n = 60) prior to treatment with a regimen associated with sleep disturbance, during 4 weeks of treatment, and upon completion of treatment.
6. To evaluate the psychometric properties of the BSDS in a sample of community dwelling adults.

Secondary Objective:

1. To obtain pilot data from a small sample of patients who will wear an actigraph for one week.

Study Overview

• Status: Completed
• Conditions: Advanced Cancer
• Intervention / Treatment: Behavioral: Questionnaire; Device: Actigraph

Detailed Description

Patients Who Complete the Surveys on Multiple Time Points:

This study will teach researchers about changes in your sleep patterns that may happen during your cancer treatment. The participants will be recruited from the Melanoma Clinic.

If you agree to take part in this study, during your cancer treatment, you will be asked to complete three written questionnaires that ask about your sleep, symptoms, and mood. These questionnaires will take about 20 minutes to complete. You will be asked to complete the questionnaires before, during and after your cancer treatment during 11 of your clinic visits.

You will also be asked to fill out a sleep diary at home, in which you will be asked to record what time you go to bed, whether you get up during the night, and what time you wake up. You will be asked to fill out the diary every day, for one week. You will be asked to return it during a clinic visit or by mail, with a stamped envelope that will be provided.

During the study, the research staff will collect information from your medical chart about your cancer, cancer treatment, and laboratory tests.

This is an investigational study. Up to 570 participants will take part in this multicenter study. Up to 380 will be enrolled at MD Anderson.

Patients Who Wear Actigraphs:

This study will help researchers to understand how cancer and cancer treatments affect sleep patterns. The participants will be recruited from the M. D. Anderson outpatient clinics, including Breast, Neuro-oncology, Blood and Marrow Transplantation, Genitourinary Oncology, Gastrointestinal Oncology Gynecologic Oncology, Head and Heck, Thoracic Oncology, Leukemia, Lymphoma, Melanoma, Sarcoma, Internal Medicine, and the Ambulatory Treatment Center.

If you agree to take part in this study, you will be asked to complete eight written questionnaires that have questions about your sleep, symptoms, and mood. These questionnaires will take about 20 minutes to complete. You will be asked to fill out the questionnaires before wearing the actigraph and after one week of wearing the actigraph.

During the study, the research staff will collect information from your medical chart about the cancer, cancer treatment, and laboratory tests.

You will be asked to wear an actigraph on your wrist for one week. An actigraph is a small motion detector that is about the size and shape of a wristwatch. The actigraph will collect and store information on your activity levels and your sleep patterns. You will be asked to return the actigraph at the end of the week.

You will be asked to fill out a sleep diary at home, in which you will be asked to record what time you go to bed, whether you get up during the night, and what time you wake up. You will only be asked to do this during the week you wear the actigraph.

At the end of the "actigraph" week, you will be asked to complete a brief sleep questionnaire, which will take about 5 minutes to complete.

This is an investigational study. About 20 patients will take part in this study. All will be enrolled at MD Anderson.

• Study Type: Observational
• Enrollment (Actual): 459

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center
    • Houston, Texas, United States, 77030
      • Lyndon Baines Johnson General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study participants with a pathological diagnosis of cancer and community dwelling adults who attend a meeting of a designated service organization.

Description

Inclusion Criteria:

1. Outpatient or inpatient receiving evaluation, treatment, or follow-up care at MDACC or a collaborating site.
2. Has a pathological diagnosis of cancer.
3. 18 years of age or older.
4. Able to understand English.
5. Gives informed consent to participate.
6. Community sample eligibility: Community dwelling adult who attends a meeting of a designated service organization.
7. Community sample eligibility: 18 years of age or older
8. Community sample eligibility: Gives Informed Consent to participate.
9. Community sample eligibility: Able to understand English.

Exclusion Criteria:

1. Cannot understand the intent of the study.
2. Patient feels too ill to complete the surveys.
3. Refuses to participate.
4. Community sample exclusion criterion: Unable to complete the surveys.
5. Community sample exclusion criterion: Refuses to participate.
6. Community sample exclusion criterion: Cancer diagnosis (past or present).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Questionnaire; Questionnaires that ask about your sleep, symptoms, and mood.	Behavioral: Questionnaire; Questionnaires that ask about your sleep, symptoms, and mood.; Other Names: Survey
Questionnaire + Actigraphs; Questionnaires that ask about your sleep, symptoms, and mood. Wear actigraph to collect information on activity levels and sleep patterns for one week.	Behavioral: Questionnaire; Questionnaires that ask about your sleep, symptoms, and mood.; Other Names: Survey; Device: Actigraph; Wear actigraph to collect information on activity levels and sleep patterns for one week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sensitivity of Brief Sleep Disturbance Scale (BSDS)	Administering to same group prior to treatment with a regimen associated with sleep disturbance, during 4 weeks of treatment, and upon completion of treatment.

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Xin S. Wang, MD,MPH, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2005
• Primary Completion (Actual): July 11, 2022
• Study Completion (Actual): July 11, 2022

Study Registration Dates

• First Submitted: July 19, 2007
• First Submitted That Met QC Criteria: July 19, 2007
• First Posted (Estimate): July 23, 2007

Study Record Updates

• Last Update Posted (Actual): July 13, 2022
• Last Update Submitted That Met QC Criteria: July 12, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Questionnaire; Survey; Sleep Quality; Advanced Cancer; Sleep Disturbance
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Dyssomnias; Parasomnias
• Other Study ID Numbers: 2004-0598

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No