New Assessment System in Measuring Symptom Distress in Cancer Patients

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Physician; Health Care Provider; Malignant Neoplasm; Caregiver

Treatments: Other: Interview; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Study type: Observational

Funder types: Other; Industry; NIH

Identifiers

NCT00505245

P30CA016672 (U.S. NIH Grant/Contract)

BS99-094 (Other Identifier)

R01CA205146 (U.S. NIH Grant/Contract)

NCI-2018-02461 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

6,500 participants in 1 patient group

Observational (questionnaire, QOL assessment, interview)

Description:

Participants complete questionnaires and quality of life assessments, and may also complete interviews over 45 minutes periodically.

Treatment:

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Other: Interview