Measuring the Symptom Distress of Cancer Patients: Development of a New Assessment System
Summary
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.
Detailed description
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.
Arms & interventions
- OtherInterview
Complete interview
- OtherQuality-of-Life Assessment
Complete quality of life assessment
- OtherQuestionnaire Administration
Complete questionnaires
Outcome measures
Primary
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.
Time frame: 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.
Time frame: Up to 21 years
MD Anderson Symptom Inventory
Mean ratings of 11-point 0-10 scales; lower mean score = better outcome.
Time frame: Baseline up to 21 years
Eastern Cooperative Oncology Group Functional Status scale
6-point 0-5 scale; lower score = better outcome.
Time frame: 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.
Time frame: Baseline up to 21 years
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 21 years
Eligibility criteria
Study locations (1)
M D Anderson Cancer Center
Houston, Texas, 77030