Clinical trial NCT00505245: New Assessment System in Measuring Symptom Distress in Cancer Patients
Official title: Measuring the Symptom Distress of Cancer Patients: Development of a New Assessment System
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Caregiver
Health Care Provider
Malignant Neoplasm
Physician
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Bayer
name: Bristol-Myers Squibb
name: Eli Lilly and Company
name: Genentech, Inc.
name: Merck Sharp & Dohme LLC
name: National Institutes of Health (NIH)
First posted: 2007-07-23
Enrollment: 6500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community dwelling adults, inpatients and outpatients with cancer being followed at University of Texas (UT) MD Anderson

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.

Eligibility 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

Primary outcomes:
measure: MD Anderson Symptom Inventory (MDASI) tool or other MD Anderson-developed patient reported outcome (PRO) instrument validity
timeFrame: Up to 21 years
measure: MD Anderson Symptom Inventory (MDASI) tool or other MD Anderson-developed PRO instrument reliability.
timeFrame: Up to 21 years
measure: MD Anderson Symptom Inventory
timeFrame: Baseline up to 21 years
measure: Eastern Cooperative Oncology Group Functional Status scale
timeFrame: Baseline up to 21 years
measure: EuroQOL 5 Dimensions questionnaire
timeFrame: Baseline up to 21 years
measure: The change in the symptom severity and interference with the function
timeFrame: Baseline up to 21 years
measure: MD Anderson Symptom Inventory (MDASI) tool or other MD Anderson-developed PRO instrument sensitivity
timeFrame: Up to 21 years
measure: The quality of life questionnaire will be assessed.
timeFrame: Up to 21 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Xin Shelley Wang
role: PRINCIPAL_INVESTIGATOR
References: