New Assessment System in Measuring Symptom Distress in Cancer Patients

Malignant Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00505245
• Other study ID #: BS99-094
• Secondary ID: NCI-2018-02461BS
• Status: Recruiting
• Start date: April 13, 1999
• Est. completion date: April 30, 2031

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: Xin Shelley Wang
• Phone: 713-745-3504
• Email: xswang[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6500
• Est. completion date: April 30, 2031
• Est. primary completion date: April 30, 2031
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Caregiver
• Health Care Provider
• Malignant Neoplasm
• Neoplasms
• Physician

Intervention

Other:
• Interview
Complete interview
• Quality-of-Life Assessment
Complete quality of life assessment
• Questionnaire Administration
Complete questionnaires

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (8)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Bayer, Bristol-Myers Squibb, Eli Lilly and Company, Genentech, Inc., Merck Sharp & Dohme LLC, National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Up to 21 years
Primary	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
Primary	MD Anderson Symptom Inventory	Mean ratings of 11-point 0-10 scales; lower mean score = better outcome.	Baseline up to 21 years
Primary	Eastern Cooperative Oncology Group Functional Status scale	6-point 0-5 scale; lower score = better outcome.	Baseline up to 21 years
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   MD Anderson Cancer Center Website