Advanced CancerNCT00505544
Measuring Sleep Disturbance Among Cancer Patients
An observational study of Advanced Cancer, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Questionnaire and Actigraph
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 459 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2005to 11 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study participants with a pathological diagnosis of cancer and community dwelling adults who attend a meeting of a designated service organization.
Who may be able to join
- Outpatient or inpatient receiving evaluation, treatment, or follow-up care at MDACC or a collaborating site.
- Has a pathological diagnosis of cancer.
- 18 years of age or older.
- Able to understand English.
- Gives informed consent to participate.
- Community sample eligibility: Community dwelling adult who attends a meeting of a designated service organization.
Show all 9Show fewer
- Community sample eligibility: 18 years of age or older
- Community sample eligibility: Gives Informed Consent to participate.
- Community sample eligibility: Able to understand English.
Who cannot join
- Cannot understand the intent of the study.
- Patient feels too ill to complete the surveys.
- Refuses to participate.
- Community sample exclusion criterion: Unable to complete the surveys.
- Community sample exclusion criterion: Refuses to participate.
- Community sample exclusion criterion: Cancer diagnosis (past or present).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lyndon Baines Johnson General Hospital
Houston, Texas, 77030
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: The Brief Sleep Disturbance Scale: Measuring Sleep Disturbance Among Cancer Patients
Objectives:
Primary Objectives:
Read more
- To establish concurrent criterion-related validity of the Brief Sleep Disturbance Scale (BSDS) by correlating the scale with the Pittsburgh Sleep Quality Index.
- To evaluate the construct validity of the BSDS through exploratory factor analysis.
- To examine possible predictors of sleep disturbance.
- To evaluate the reliability of the BSDS using Cronbach's coefficient alpha and test-retest reliability.
- 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.
- To evaluate the psychometric properties of the BSDS in a sample of community dwelling adults.
Secondary Objective:
- To obtain pilot data from a small sample of patients who will wear an actigraph for one week.
Read the 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.
- Conditions
- Advanced Cancer
- Being tested
- Questionnaire, Actigraph
- Keywords
- Advanced Cancer, Questionnaire, Survey, Sleep Disturbance, Sleep Quality
- Medical subject headings
- Parasomnias, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
Questionnaires that ask about your sleep, symptoms, and mood.
ActigraphDevice
Wear actigraph to collect information on activity levels and sleep patterns for one week.
| Study group | Role | What they receive |
|---|---|---|
| Questionnaire | Questionnaires that ask about your sleep, symptoms, and mood. Receives: Behavioral: Questionnaire | |
| 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. Receives: Behavioral: Questionnaire; Device: Actigraph |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of Brief Sleep Disturbance Scale (BSDS)
Measured: Administering to same group prior to treatment with a regimen associated with sleep disturbance, during 4 weeks of treatment, and upon completion of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2007 (estimated)
- Study startAug 2005
- Primary completion11 Jul 2022
- Study completion11 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 459 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xin S. Wang, MD,MPH, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00505544
- Sponsor's protocol ID
- 2004-0598
- Status last verified
- Jul 2022
- First submitted
- 19 Jul 2007
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Brief Sleep Disturbance Scale: Measuring Sleep Disturbance Among Cancer Patients
- ClinicalTrials.gov ID
- NCT00505544
- Acronym / sponsor ID
- 2004-0598
- Conditions
- Advanced Cancer
- Keywords
- Advanced Cancer, Questionnaire, Survey, Sleep Disturbance, Sleep Quality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 459 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Aug 2005 (actual)
- Primary completion
- 11 Jul 2022 (actual)
- Study completion
- 11 Jul 2022 (actual)
- First posted
- 23 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives:
Primary Objectives:
- To establish concurrent criterion-related validity of the Brief Sleep Disturbance Scale (BSDS) by correlating the scale with the Pittsburgh Sleep Quality Index.
- To evaluate the construct validity of the BSDS through exploratory factor analysis.
- To examine possible predictors of sleep disturbance.
- To evaluate the reliability of the BSDS using Cronbach's coefficient alpha and test-retest reliability.
- 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.
- To evaluate the psychometric properties of the BSDS in a sample of community dwelling adults.
Secondary Objective:
- To obtain pilot data from a small sample of patients who will wear an actigraph for one week.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Questionnaire | – | Behavioral: QuestionnaireQuestionnaires that ask about your sleep, symptoms, and mood. |
| Questionnaire + Actigraphs | – | Behavioral: Questionnaire, Device: ActigraphQuestionnaires that ask about your sleep, symptoms, and mood. Wear actigraph to collect information on activity levels and sleep patterns for one week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants with a pathological diagnosis of cancer and community dwelling adults who attend a meeting of a designated service organization.
Key inclusion criteria (9 listed)
- Outpatient or inpatient receiving evaluation, treatment, or follow-up care at MDACC or a collaborating site.
- Has a pathological diagnosis of cancer.
- 18 years of age or older.
- Able to understand English.
- Gives informed consent to participate.
Key exclusion criteria (6 listed)
- Cannot understand the intent of the study.
- Patient feels too ill to complete the surveys.
- Refuses to participate.
- Community sample exclusion criterion: Unable to complete the surveys.
- Community sample exclusion criterion: Refuses to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAlso: SurveyQuestionnaires that ask about your sleep, symptoms, and mood. | Behavioural | Questionnaire, Questionnaire + Actigraphs |
| ActigraphWear actigraph to collect information on activity levels and sleep patterns for one week. | Device | Questionnaire + Actigraphs |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xin S. Wang, MD,MPH principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Cancer, run by M.D. Anderson Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2022.