New Assessment System in Measuring Symptom Distress in Cancer Patients

Recruiting

• Conditions: Health Care Provider; Caregiver; Malignant Neoplasm; Physician
• Interventions: Other: Interview; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

• Registration Number: NCT00505245
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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.

Study Timeline

• Study Start: 1999-04-13
• Study First Submitted: 2007-07-19
• Study First Submitted QC: 2007-07-20
• Study First Posted: 2007-07-23
• Status Verified: 2024-06
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-05
• Primary Completion: 2031-04-30
• Study Completion: 2031-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6500

Inclusion Criteria

• NORMAL SAMPLES: Community dwelling adults 18 years of age or older
• PATIENT SAMPLES: Inpatients and outpatients 18 years of age or older, being followed at UT MD Anderson
• EXPERT PANEL PROFESSIONAL PARTICIPANTS: Physician or other healthcare provider with at least 5 years of experience caring for patients with the disease and/or treatment of interest, at least one publication in the last 5 years dealing with the disease and/or treatment of interest (physician only), ability to speak and read English, consent to participate
• EXPERT PANEL FAMILY CAREGIVERS PARTICIPANTS: Identification as a family caregiver by patient enrolled as expert panel participant with the disease and/or treatment of interest, 18 years of age or older, ability to speak and read English, consent to participate
• EXPERT PANEL PATIENT PARTICIPANTS: Patient with identified family caregiver participating on Expert Panel, willingness to receive packet for expert panel participation

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Exclusion Criteria

• EXPERT PANEL PATIENT PARTICIPANTS: Patient with identified family caregiver participating on expert panel, willingness to receive packet for expert panel participation

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (questionnaire, QOL assessment, interview)	Interview	Participants complete questionnaires and quality of life assessments, and may also complete interviews over 45 minutes periodically.
Observational (questionnaire, QOL assessment, interview)	Quality-of-Life Assessment	Participants complete questionnaires and quality of life assessments, and may also complete interviews over 45 minutes periodically.
Observational (questionnaire, QOL assessment, interview)	Questionnaire Administration	Participants complete questionnaires and quality of life assessments, and may also complete interviews over 45 minutes periodically.

Primary Outcome Measures

Name	Time	Method
MD Anderson Symptom Inventory (MDASI) tool or other MD Anderson-developed PRO instrument reliability.	Up to 21 years	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.
MD Anderson Symptom Inventory (MDASI) tool or other MD Anderson-developed PRO instrument sensitivity	Up to 21 years	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.
The quality of life questionnaire will be assessed.	Up to 21 years	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.
Eastern Cooperative Oncology Group Functional Status scale	Baseline up to 21 years	6-point 0-5 scale; lower score = better outcome.
MD Anderson Symptom Inventory (MDASI) tool or other MD Anderson-developed patient reported outcome (PRO) instrument validity	Up to 21 years	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.
MD Anderson Symptom Inventory	Baseline up to 21 years	Mean ratings of 11-point 0-10 scales; lower mean score = better outcome.
EuroQOL 5 Dimensions questionnaire	Baseline up to 21 years	Scored on 5-point 1 to 5 scales; combined scores converted to index value for US = -0.573 to 1; higher values = better outcome.
The change in the symptom severity and interference with the function	Baseline up to 21 years	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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States