An observational study in Advanced Cancer, sponsored by M.D. Anderson Cancer Center. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-13.
Sponsored by M.D. Anderson Cancer Center · Observational
Objectives:
Primary Objectives:
Secondary Objective:
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.
324 studies on the registry are indexed under Dyssomnias; 51 are open to participants now.
This study's enrollment of 459 is above the median of 126 across 63 observational studies indexed under Dyssomnias.
Browse Dyssomnias studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Study participants with a pathological diagnosis of cancer and community dwelling adults who attend a meeting of a designated service organization.
Exclusion Criteria:
Questionnaires that ask about your sleep, symptoms, and mood.
Behavioral: Questionnaire
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 · Device: Actigraph
Questionnaires that ask about your sleep, symptoms, and mood.
Also known as: Survey
Wear actigraph to collect information on activity levels and sleep patterns for one week.
Sensitivity of Brief Sleep Disturbance Scale (BSDS)
Time frame: Administering to same group prior to treatment with a regimen associated with sleep disturbance, during 4 weeks of treatment, and upon completion of treatment.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center