New Assessment System in Measuring Symptom Distress in Cancer Patients

NCT00505245 | Recruiting

• 4 other identifiers: BS99-094NCI-2018-02461P30CA016672R01CA205146
• Study Type: observational
• Target: 6,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Caregiver; Health Care Provider; Malignant Neoplasm; Physician

Outcome Measures

Primary Outcomes (8)

• 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.

  Up to 21 years

• 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.

  Up to 21 years

• MD Anderson Symptom Inventory

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

  Baseline up to 21 years

• Eastern Cooperative Oncology Group Functional Status scale

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

  Baseline up to 21 years

• EuroQOL 5 Dimensions questionnaire

  Scored on 5-point 1 to 5 scales; combined scores converted to index value for US = -0.573 to 1; higher values = better outcome.

  Baseline up to 21 years

• The change in the symptom severity and interference with the function

  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.

  Baseline up to 21 years

• MD Anderson Symptom Inventory (MDASI) tool or other MD Anderson-developed PRO instrument sensitivity

  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.

  Up to 21 years

• The quality of life questionnaire will be assessed.

  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.

  Up to 21 years

Study Arms (1)

Observational (questionnaire, QOL assessment, interview)

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

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

Interventions

Interview OTHER

Complete interview

Observational (questionnaire, QOL assessment, interview)

Quality-of-Life Assessment OTHER

Complete quality of life assessment

Also known as: Quality of Life Assessment

Observational (questionnaire, QOL assessment, interview)

Questionnaire Administration OTHER

Complete questionnaires

Observational (questionnaire, QOL assessment, interview)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• Bayer: collaborator
• Bristol-Myers Squibb: collaborator
• Eli Lilly and Company: collaborator
• Genentech, Inc.: collaborator
• Merck Sharp & Dohme LLC: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Neoplasms

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Xin Shelley Wang

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Shelley Wang

CONTACT

713-745-3504; xswang@mdanderson.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2007
• First Posted: July 23, 2007
• Study Start: April 13, 1999
• Primary Completion (Estimated): April 30, 2031
• Study Completion (Estimated): April 30, 2031
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

US (1)