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New Assessment System in Measuring Symptom Distress in Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00505245
Recruitment Status : Recruiting
First Posted : July 23, 2007
Last Update Posted : June 30, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Bayer
Bristol-Myers Squibb
Eli Lilly and Company
Genentech, Inc.
Merck Sharp & Dohme Corp.
National Institutes of Health (NIH)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Caregiver Health Care Provider Malignant Neoplasm Physician Other: Interview Other: Quality-of-Life Assessment Other: Questionnaire Administration

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.

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Study Type : Observational
Estimated Enrollment : 6500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measuring the Symptom Distress of Cancer Patients: Development of a New Assessment System
Actual Study Start Date : April 13, 1999
Estimated Primary Completion Date : April 30, 2030
Estimated Study Completion Date : April 30, 2031

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Group/Cohort Intervention/treatment
Observational (questionnaire, QOL assessment, interview)
Participants complete questionnaires and quality of life assessments, and may also complete interviews over 45 minutes periodically.
Other: Interview
Complete interview

Other: Quality-of-Life Assessment
Complete quality of life assessment
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Complete questionnaires




Primary Outcome Measures :
  1. MD Anderson Symptom Inventory (MDASI) tool or other MD Anderson-developed patient reported outcome (PRO) instrument validity [ Time Frame: 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.

  2. MD Anderson Symptom Inventory (MDASI) tool or other MD Anderson-developed PRO instrument reliability. [ Time Frame: 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.

  3. MD Anderson Symptom Inventory [ Time Frame: Baseline up to 21 years ]
    Mean ratings of 11-point 0-10 scales; lower mean score = better outcome.

  4. Eastern Cooperative Oncology Group Functional Status scale [ Time Frame: Baseline up to 21 years ]
    6-point 0-5 scale; lower score = better outcome.

  5. EuroQOL 5 Dimensions questionnaire [ Time Frame: 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.

  6. The change in the symptom severity and interference with the function [ Time Frame: 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.

  7. MD Anderson Symptom Inventory (MDASI) tool or other MD Anderson-developed PRO instrument sensitivity [ Time Frame: 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.

  8. The quality of life questionnaire will be assessed. [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community dwelling adults, inpatients and outpatients with cancer being followed at University of Texas (UT) MD Anderson
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00505245


Contacts
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Contact: Lori Wiilams 713-745-3470 loriwilliams@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Lori Williams    713-745-3470      
Principal Investigator: Lori Williams         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Bayer
Bristol-Myers Squibb
Eli Lilly and Company
Genentech, Inc.
Merck Sharp & Dohme Corp.
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Lori Williams M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00505245    
Other Study ID Numbers: BS99-094
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 )
R01CA205146 ( U.S. NIH Grant/Contract )
First Posted: July 23, 2007    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms