Measuring Sleep Disturbance Among Cancer Patients
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/15/2018 |
| Start Date: | August 2005 |
| End Date: | August 2019 |
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.
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.
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.
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.
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).
We found this trial at
2
sites
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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