CaregiverNCT00505245
New Assessment System in Measuring Symptom Distress in Cancer Patients
An observational study of Caregiver and Health Care Provider, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver, Health Care Provider, Malignant Neoplasm
- What is being tested?
- Interview, Quality-of-Life Assessment and Questionnaire Administration
- How many people
- 6,500 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 1999to 30 Apr 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community dwelling adults, inpatients and outpatients with cancer being followed at University of Texas (UT) MD Anderson
Who may be able to join
- 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
Who cannot join
- EXPERT PANEL PATIENT PARTICIPANTS: Patient with identified family caregiver participating on expert panel, willingness to receive packet for expert panel participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Xin Shelley Wang, 713-745-3504
Xin Shelley Wang
About this study
Official title: Measuring the Symptom Distress of Cancer Patients: Development of a New Assessment System
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- 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.
- Conditions
- Caregiver, Health Care Provider, Malignant Neoplasm, Physician
- Being tested
- Interview, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Complete interview
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Complete quality of life assessment
Questionnaire AdministrationOther
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Observational (questionnaire, QOL assessment, interview) | Participants complete questionnaires and quality of life assessments, and may also complete interviews over 45 minutes periodically. Receives: Other: Interview; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 21 years
MD Anderson Symptom Inventory
Mean ratings of 11-point 0-10 scales; lower mean score = better outcome.
Measured: Baseline up to 21 years
Eastern Cooperative Oncology Group Functional Status scale
6-point 0-5 scale; lower score = better outcome.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 21 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2007 (estimated)
- Study start13 Apr 1999
- Primary completion30 Apr 2031 (estimated)
- Study completion30 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaregiverStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Bayer, Bristol-Myers Squibb, Eli Lilly and Company, Genentech, Inc., Merck Sharp & Dohme LLC, National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Xin Shelley Wang, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00505245
- Sponsor's protocol ID
- BS99-094
- Other IDs
- NCI-2018-02461, BS99-094, P30CA016672, R01CA205146
- Status last verified
- Jul 2026
- First submitted
- 19 Jul 2007
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Symptom Distress of Cancer Patients: Development of a New Assessment System
- ClinicalTrials.gov ID
- NCT00505245
- Acronym / sponsor ID
- BS99-094
- Conditions
- Caregiver, Health Care Provider, Malignant Neoplasm, Physician
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,500 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Bayer, Bristol-Myers Squibb, Eli Lilly and Company, Genentech, Inc., Merck Sharp & Dohme LLC, National Institutes of Health (NIH)
- Study start
- 13 Apr 1999 (actual)
- Primary completion
- 30 Apr 2031 (estimated)
- Study completion
- 30 Apr 2031 (estimated)
- First posted
- 23 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (questionnaire, QOL assessment, interview) | – | Other: Interview, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationParticipants complete questionnaires and quality of life assessments, and may also complete interviews over 45 minutes periodically. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community dwelling adults, inpatients and outpatients with cancer being followed at University of Texas (UT) MD Anderson
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- EXPERT PANEL PATIENT PARTICIPANTS: Patient with identified family caregiver participating on expert panel, willingness to receive packet for expert panel participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewComplete interview | Other | Observational (questionnaire, QOL assessment, interview) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentComplete quality of life assessment | Other | Observational (questionnaire, QOL assessment, interview) |
| Questionnaire AdministrationComplete questionnaires | Other | Observational (questionnaire, QOL assessment, interview) |
Primary outcome
MD Anderson Symptom Inventory (MDASI) tool or other MD Anderson-developed patient reported outcome (PRO) instrument validity
Time frame: Up to 21 years
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.
MD Anderson Symptom Inventory (MDASI) tool or other MD Anderson-developed PRO instrument reliability.
Time frame: Up to 21 years
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.
MD Anderson Symptom Inventory
Time frame: Baseline up to 21 years
Mean ratings of 11-point 0-10 scales; lower mean score = better outcome.
Eastern Cooperative Oncology Group Functional Status scale
Time frame: Baseline up to 21 years
6-point 0-5 scale; lower score = better outcome.
EuroQOL 5 Dimensions questionnaire
Time frame: Baseline up to 21 years
Scored on 5-point 1 to 5 scales; combined scores converted to index value for US = -0.573 to 1; higher values = better outcome.
The change in the symptom severity and interference with the function
Time frame: Baseline up to 21 years
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.
MD Anderson Symptom Inventory (MDASI) tool or other MD Anderson-developed PRO instrument sensitivity
Time frame: Up to 21 years
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.
The quality of life questionnaire will be assessed.
Time frame: Up to 21 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xin Shelley Wang principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Caregiver and Health Care Provider, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xin Shelley Wang (713-745-3504, xswang@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MD Anderson Symptom Inventory (MDASI) tool or other MD Anderson-developed patient reported outcome (PRO) instrument validity (time frame: Up to 21 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.