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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-02461 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| BS99-094 | Other Identifier | M D Anderson Cancer Center | |
| P30CA016672 | U.S. NIH Grant/Contract | View source | |
| R01CA205146 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Bayer | INDUSTRY |
| Bristol-Myers Squibb | INDUSTRY |
| Eli Lilly and Company |
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This trial studies how well a new assessment system (MDASI or other MD Anderson-developed PRO instrument) works in measuring symptoms and the impact on quality of life in cancer patients. Development of a new assessment system may provide more information about the common symptoms that may occur in patients due to cancer and its treatment and how the symptoms impact quality of life.
PRIMARY OBJECTIVES:
I. To examine how the MD Anderson Inventory (MD Anderson Symptom Inventory [MDASI]) or other MD Anderson-developed patient reported outcome (PRO) instrument performs in various sample populations including community dwelling adults and patients who have different cancer types, who have undergone various treatments, and who have different and/or more severe symptoms.
II. To evaluate the MDASI or other MD Anderson-developed PRO instrument as an estimate of functional status and quality of life.
III. To assess the impact of symptom severity on standard function and health-related quality of life measures, including both quantitative and qualitative measures (patient interviews).
IV. To assess the pattern and severity of symptoms over multiple time points in order to assay the system's responsiveness to changes due to therapy or disease.
V. To explore the utility of an interactive voice response (IVR) system in enhancing the clinical care of outpatients.
VI. To explore the effect of information from an IVR symptom assessment system on the pattern of care and development of interdisciplinary protocols.
VII. To explore the feasibility of developing symptom management pathways for patients based on these symptom and quality of life data.
OUTLINE:
Participants complete questionnaires and quality of life assessments, and may also complete interviews over 45 minutes periodically.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (questionnaire, QOL assessment, interview) | Participants complete questionnaires and quality of life assessments, and may also complete interviews over 45 minutes periodically. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interview | Other | Complete interview |
| |
| Measure | Description | Time Frame |
|---|---|---|
| MD Anderson Symptom Inventory (MDASI) tool or other MD Anderson-developed patient reported outcome (PRO) instrument validity | Each item is rated 0 to 10 with 0 = symptom not present or no interference and 10 meaning the symptom severity is as bad as can be imaged or complete interference. The symptom severity and interference sub scales are mean values of the items in each scale. Hence the range of each sub scale is also 0 to 10. Lower values represent a better outcome. Higher values represent a worse outcome. The symptom severity and interference sub scales are not combined to compute a total score. | Up to 21 years |
| MD Anderson Symptom Inventory (MDASI) tool or other MD Anderson-developed PRO instrument reliability. | Each item is rated 0 to 10 with 0 = symptom not present or no interference and 10 meaning the symptom severity is as bad as can be imaged or complete interference. The symptom severity and interference sub scales are mean values of the items in each scale. Hence the range of each sub scale is also 0 to 10. Lower values represent a better outcome. Higher values represent a worse outcome. The symptom severity and interference sub scales are not combined to compute a total score. | Up to 21 years |
| MD Anderson Symptom Inventory | Mean ratings of 11-point 0-10 scales; lower mean score = better outcome. | Baseline up to 21 years |
| Eastern Cooperative Oncology Group Functional Status scale | 6-point 0-5 scale; lower score = better outcome. | Baseline up to 21 years |
| EuroQOL 5 Dimensions questionnaire | Scored on 5-point 1 to 5 scales; combined scores converted to index value for US = -0.573 to 1; higher values = better outcome. | Baseline up to 21 years |
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Inclusion Criteria:
Exclusion Criteria:
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Community dwelling adults, inpatients and outpatients with cancer being followed at University of Texas (UT) MD Anderson
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Shelley Wang | Contact | 713-745-3504 | xswang@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Xin Shelley Wang | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| INDUSTRY |
| Genentech, Inc. | INDUSTRY |
| Merck Sharp & Dohme LLC | INDUSTRY |
| National Institutes of Health (NIH) | NIH |
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| Quality-of-Life Assessment |
| Other |
Complete quality of life assessment |
|
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| Questionnaire Administration | Other | Complete questionnaires |
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| The change in the symptom severity and interference with the function | Changes in patients' symptoms over time will be determined by differences in symptom severity scores on the MD Anderson Symptom Inventory MDASI collected at multiple time points. 0 to 10 with 0 = symptom not present or no interference and 10 meaning the symptom severity is as bad as can be imaged or complete interference. The symptom severity and interference sub scales are mean values of the items in each scale. Hence the range of each sub scale is also 0 to 10. Lower values represent a better outcome. Higher values represent a worse outcome. The symptom severity and interference sub scales are not combined to compute a total score. | Baseline up to 21 years |
| MD Anderson Symptom Inventory (MDASI) tool or other MD Anderson-developed PRO instrument sensitivity | Each item is rated 0 to 10 with 0 = symptom not present or no interference and 10 meaning the symptom severity is as bad as can be imaged or complete interference. The symptom severity and interference sub scales are mean values of the items in each scale. Hence the range of each sub scale is also 0 to 10. Lower values represent a better outcome. Higher values represent a worse outcome. The symptom severity and interference sub scales are not combined to compute a total score. | Up to 21 years |
| The quality of life questionnaire will be assessed. | The European Organization for Cancer Treatment and Research Quality of Life scale (EORTC QLQ-C30) is a quality of life questionnaire that measures five functional areas (physical, social, role, cognitive, and emotional), eight symptoms (fatigue, nausea/vomiting, pain, dyspepsia, sleep disturbance, diarrhea, appetite loss, and constipation), financial impact, and overall quality of life. All of the sub scales and single-item measures range in score from 0 to 100 according to scoring algorithms. | Up to 21 years |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |