NCT00505245

New Assessment System in Measuring Symptom Distress in Cancer Patients

Measuring the Symptom Distress of Cancer Patients: Development of a New Assessment System

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 6,500 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Caregiver
• Health Care Provider
• Malignant Neoplasm
• Physician

Interventions

Type	Name	Description
OTHER	Interview	Complete interview
OTHER	Quality-of-Life Assessment	Complete quality of life assessment
OTHER	Questionnaire Administration	Complete questionnaires

Timeline

• Start date: 1999-04-13
• Primary completion: 2031-04-30
• Completion: 2031-04-30
• First posted: 2007-07-23
• Last updated: 2026-01-21

Locations

1 site across 1 country: United States