About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Community dwelling adults, inpatients and outpatients with cancer being followed at University of Texas (UT) MD Anderson

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

Treatment groups

6,500 Participants

are divided into 1 treatment group

Group A: Observational (questionnaire, QOL assessment, interview)3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame

Up to 21 years

2

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.

Time frame

Up to 21 years

3

MD Anderson Symptom Inventory

Mean ratings of 11-point 0-10 scales; lower mean score = better outcome.

Time frame

Baseline up to 21 years

4

Eastern Cooperative Oncology Group Functional Status scale

6-point 0-5 scale; lower score = better outcome.

Time frame

Baseline up to 21 years

New Assessment System in Measuring Symptom Distress in Cancer Patients

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial population

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts