Spinal Cord TumorNCT00430872
Development of the MDASI-Spine Tumor Module
An observational study of Spinal Cord Tumor, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this research study is to learn the severity of certain symptoms in patients with tumors of the spine or spinal cord. Researchers also want to learn if the M. D. Anderson Symptom Inventory-Spine is a good way to rate these symptoms. Primary Objective: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Tumor
- What is being tested?
- Survey
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jul 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a tumor on the spine or spinal cord.
Who may be able to join
- Diagnosis of a tumor involving the spinal cord (intramedullary or extramedullary)
- Age > or = to 18 years of age
- Ability to speak and read English. Non-English speaking subjects will be included in future studies, once the final instrument has been developed.
Who cannot join
- Patients < 18 years of age
- Evidence of gross cognitive dysfunction limiting memory or ability to complete a self-report questionnaire as determined by evaluation of physician or mid-level provider.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T. M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Validation of the M.D. Anderson Symptom Inventory-Spine Tumor Module
The goal of this research study is to learn the severity of certain symptoms in patients with tumors of the spine or spinal cord. Researchers also want to learn if the M. D. Anderson Symptom Inventory-Spine is a good way to rate these symptoms.
Primary Objective:
- To evaluate the psychometric properties of the MDASI-Spine in patients with tumors involving the spine or spinal cord.
Secondary Objective:
- To describe the severity of commonly occurring symptoms experienced by persons with spine tumors.
Read the detailed description
If you agree to take part in this study, you will complete the M. D. Anderson Symptom Inventory-Spine Tumor Module survey. This survey will ask you to rate the severity of certain symptoms you may have had in the last 24 hours on a scale of 0 (not present) to 10 (the most severe you can imagine). You will also be asked to rate how your symptoms get in the way of your daily activities using the same 0 to 10 scale. This survey should take about 10-15 minutes to complete.
Information regarding your clinical history (tumor type, location, treatment, and other medications) and demographic information (age, gender, ethnicity, religion, educational level, and marital status) will also be collected. This information will be used to evaluation whether there is an association between symptom severity and these factors.
Once you have completed the survey, your participation on this study will be over.
This is an investigational study. Up to 128 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Spinal Cord Tumor
- Being tested
- Survey
- Keywords
- Spinal Cord Tumor, Intramedullary Spinal Cord Tumor, Extramedullary Spinal Cord Tumor, Symptoms, Survey
- Medical subject headings
- Spinal Cord Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyBehavioural
Also called MDASI-Spine
Survey about the severity of certain symptoms lasting 10-15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| MDASI-Spine Tumor Module Survey | M. D. Anderson Symptom Inventory-Spine (survey) of patients with a tumor on the spine or spinal cord. Receives: Behavioral: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall MDASI Score
Measured: 18 Months
Secondary outcomes (1)
Proportion of Patients Reporting Symptom Severity >4 on 0-10 Scale
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2007 (estimated)
- Study startJan 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord TumorStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Terri S. Armstrong, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00430872
- Sponsor's protocol ID
- 2006-0809
- Status last verified
- Jul 2012
- First submitted
- 1 Feb 2007
- Last updated
- 1 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the M.D. Anderson Symptom Inventory-Spine Tumor Module
- ClinicalTrials.gov ID
- NCT00430872
- Acronym / sponsor ID
- 2006-0809
- Conditions
- Spinal Cord Tumor
- Keywords
- Spinal Cord Tumor, Intramedullary Spinal Cord Tumor, Extramedullary Spinal Cord Tumor, Symptoms, Survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 2 Feb 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.
The goal of this research study is to learn the severity of certain symptoms in patients with tumors of the spine or spinal cord. Researchers also want to learn if the M. D. Anderson Symptom Inventory-Spine is a good way to rate these symptoms.
Primary Objective:
- To evaluate the psychometric properties of the MDASI-Spine in patients with tumors involving the spine or spinal cord.
Secondary Objective:
- To describe the severity of commonly occurring symptoms experienced by persons with spine tumors.
Detailed description
If you agree to take part in this study, you will complete the M. D. Anderson Symptom Inventory-Spine Tumor Module survey. This survey will ask you to rate the severity of certain symptoms you may have had in the last 24 hours on a scale of 0 (not present) to 10 (the most severe you can imagine). You will also be asked to rate how your symptoms get in the way of your daily activities using the same 0 to 10 scale. This survey should take about 10-15 minutes to complete.
Information regarding your clinical history (tumor type, location, treatment, and other medications) and demographic information (age, gender, ethnicity, religion, educational level, and marital status) will also be collected. This information will be used to evaluation whether there is an association between symptom severity and these factors.
Once you have completed the survey, your participation on this study will be over.
This is an investigational study. Up to 128 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MDASI-Spine Tumor Module Survey | – | Behavioral: SurveyM. D. Anderson Symptom Inventory-Spine (survey) of patients with a tumor on the spine or spinal cord. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a tumor on the spine or spinal cord.
Key inclusion criteria (3 listed)
- Diagnosis of a tumor involving the spinal cord (intramedullary or extramedullary)
- Age > or = to 18 years of age
- Ability to speak and read English. Non-English speaking subjects will be included in future studies, once the final instrument has been developed.
Key exclusion criteria (2 listed)
- Patients < 18 years of age
- Evidence of gross cognitive dysfunction limiting memory or ability to complete a self-report questionnaire as determined by evaluation of physician or mid-level provider.
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 |
|---|---|---|
| SurveyAlso: MDASI-SpineSurvey about the severity of certain symptoms lasting 10-15 minutes. | Behavioural | MDASI-Spine Tumor Module Survey |
Primary outcome
Overall MDASI Score
Time frame: 18 Months
1 secondary outcome
Proportion of Patients Reporting Symptom Severity >4 on 0-10 Scale
Time frame: 18 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2012.
- UT MD Anderson Cancer CenterLink 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. This study is not recruiting at the moment.
Terri S. Armstrong, PhD 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 Spinal Cord Tumor, 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 1 Aug 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall MDASI Score (time frame: 18 Months). 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 1 Aug 2012.