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New Assessment System in Measuring Symptom Distress in Cancer Patients

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ClinicalTrials.gov Identifier: NCT00505245
Recruitment Status : Recruiting
First Posted : July 23, 2007
Last Update Posted : November 20, 2018
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 : 5500 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, 2020
Estimated Study Completion Date : April 30, 2020

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. Effort Expenditure for Rewards Task (EEfRT) evaluated by questionnaires. [ Time Frame: Up to 21 years ]
    The endpoint for the EEfRT is the ratio of hard task choices (number of hard-task choices/total choices) across levels of probability.

  2. Levels of C-reactive protein and interleukin-6 and the ratios of kynurenine to tryptophan will be compared between high-fatigue and low-fatigue survivors, using independent t-tests. [ Time Frame: Up to 21 years ]
  3. Change in symptom severity [ Time Frame: Baseline up to 21 years ]
    Will use descriptive statistics to describe how patients rate the symptom severity.

  4. Change in symptom interference with function [ Time Frame: Baseline up to 21 years ]
    Will use descriptive statistics to describe how patients rate the symptom interference with function.

  5. Individual differences in self-reported fatigue assessed by MD Anderson Symptom Inventory-Head and Neck (MDASI-HN) [ Time Frame: Up to 21 years ]


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
MDACC participants with cancer diagnosis.
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     History of Changes
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: November 20, 2018
Last Verified: November 2018

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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