Gastrointestinal Stromal TumorsNCT01178307
Symptom Inventory for Gastrointestinal Stromal Tumors
An observational study of Gastrointestinal Stromal Tumors, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this research study is to better understand the symptoms experienced by patients with GIST. There are 3 parts to this study. In Part 1, participants will complete 1 set of interviews and questionnaires about GIST symptoms. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Stromal Tumors
- What is being tested?
- Questionnaires, Interview and MDASI-GIST Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 187 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2010to 31 Jul 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: UT MD Anderson Cancer Center Sarcoma and Surgical Oncology Clinics GIST Patients, their caregivers, doctors and nurses who are 18 years or older.
Who may be able to join
- 18 years of age or older (Patient and family caregiver only)
- Ability to speak and read English (All participants)
- Residing where IVR service is available (Part 3, Patient only)
- Diagnosis of GIST confirmed by pathological analysis (Patient only)
- Starting new treatment (either surgical or medical) and planning to be followed at M.D. Anderson Cancer Center (Part 3, Patient only)
- Written consent to participate (All participants)
Show all 12Show fewer
- At least 3 months from start of initial treatment (surgical or medical) for GIST (Part 2, Patient only)
- Family caregiver also willing to receive packet for expert panel participation (Part 2, Patient only)
- Physician or nurse with at least 5 years experience caring for patients with GIST (Professional expert only)
- At least one publication in the last 5 years dealing with GIST (Physician professional expert only)
- Identification as a family caregiver by a patient with GIST (Family caregiver only)
- Patient also willing to receive packet for expert panel participation (Family caregiver only)
Who cannot join
- Medical condition or impaired performance status that would preclude participation in the study (Patient only)
- Diagnosis of active psychosis or severe cognitive impairment as determined by primary physician (Patient only)
- Active treatment (systemic drug therapy or radiation therapy) for a second malignancy (Patient only)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Symptom Burden in Patients With Gastrointestinal Stromal Tumors (GISTs)
The goal of this research study is to better understand the symptoms experienced by patients with GIST.
There are 3 parts to this study. In Part 1, participants will complete 1 set of interviews and questionnaires about GIST symptoms. In Part 2, the importance of some symptoms to patients with GIST will be rated by doctors, nurses, patients, and family caregivers. In Part 3, participants will complete questionnaires about GIST symptoms over 1 year.
You are being asked to take part in Part 3 of the study.
Read the detailed description
Symptom Questionnaires:
If you agree to take part in this study, you will complete questionnaires about symptoms you are having. You will be asked to fill these out 1 time a week during the first 2 months after surgery, 1 time a week during the first 3 months of a new therapy, and every 2 weeks at other times. The questionnaire will ask you to rate how severe your symptoms are and how the symptoms effect the activities of your daily life. The symptom questionnaire should take about 5 minutes to complete. You will complete the questionnaire during the first study visit and at your regular clinic visits.
Between clinic visits, you will be called every 1-2 weeks to complete the questionnaire using an automated telephone system. You can decide what time is most convenient for the automated phone system to call you. If you are not available when the automated system calls, it will call you again at a later time. If you are not reached by the automated phone system after several tries, the study staff will call you. You will be given a secure user name and identification number to use with the automated phone system. The study staff will teach you how to use the automated phone system.
At the clinic visit closest to 3 months after you start the study, you may be seen by a research staff member a second time 1 to 3 days after you completed the symptom questionnaire and asked to fill out the symptom questionnaire again. The research staff member may contact you by phone prior to this clinic visit to arrange times to meet you for the 2 assessments.
Quality-of-Life/Demographic Questionnaires:
At the first visit and the regular clinic visits, you will also rate your overall quality-of-life. This should take about 1 minute to complete.
At the first visit, you will also be asked some demographic questions (such as your age and marital status). Answering these questions should take about 1 minute.
Opinion Questionnaire:
If you are 1 of the first 40 patients enrolled in the study, you will be asked questions about your opinion of the symptom questionnaire at the clinic visit closest to 3 months after you start the study. For example, you will be asked if the symptom questionnaire was easy to understand and complete, and if there were any other questions that should be included. The study staff will use your opinion to decide if changes should be made to the questionnaire or if important symptom questions are missing from the questionnaire. This questionnaire should take about 5 minutes to complete.
Length of Study:
You will be on study for 1 year. You will be off study after you complete the last symptom questionnaire.
This is an investigational study.
Up to 188 participants will take part in this study. Up to 150 participants will be enrolled in Part 3 of this study. All will be enrolled at MD Anderson.
- Conditions
- Gastrointestinal Stromal Tumors
- Being tested
- Questionnaires, Interview, MDASI-GIST Questionnaire
- Keywords
- GI cancers, GIST, Symptom Severity, Quality of Life, Questionnaire, M.D. Anderson Symptom Inventory, MDASI-GIST, patient-reported outcomes
- Medical subject headings
- Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
Also called survey
10 minutes to complete 3 questionnaires for development of MDASI-GIST
InterviewBehavioural
Each interview will take approximately 30 minutes.
MDASI-GIST QuestionnaireBehavioural
Also called survey
Every 4 weeks for one year
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Patient interview and developmental questionnaires Receives: Behavioral: Questionnaires; Behavioral: Interview | |
| Part 2 | Content Expert Panel (doctors, nurses) + Patients and Caregivers Questionnaire Development Receives: Behavioral: Questionnaires | |
| Part 3 | Patient MDASI-GIST Questionnaire Receives: Behavioral: MDASI-GIST Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire Responses to Symptom Inventory for Gastrointestinal Stromal Tumors
Descriptive statistics used to assess the distributional characteristics and demographics of the study population and to report how patients rate symptom severity and interference with function.
Measured: Patients will be followed on study for 1 year regardless of changes in disease stage or treatments.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2010 (estimated)
- Study start29 Jul 2010
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Stromal TumorsStudies 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
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Loretta A. Williams, PhD, MSN, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01178307
- Sponsor's protocol ID
- 2010-0267
- Status last verified
- Jan 2020
- First submitted
- 6 Aug 2010
- Last updated
- 13 Jan 2020
- 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 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom Burden in Patients With Gastrointestinal Stromal Tumors (GISTs)
- ClinicalTrials.gov ID
- NCT01178307
- Acronym / sponsor ID
- 2010-0267
- Conditions
- Gastrointestinal Stromal Tumors
- Keywords
- GI cancers, GIST, Symptom Severity, Quality of Life, Questionnaire, M.D. Anderson Symptom Inventory, MDASI-GIST, patient-reported outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 187 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 29 Jul 2010 (actual)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 10 Aug 2010 (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 better understand the symptoms experienced by patients with GIST.
There are 3 parts to this study. In Part 1, participants will complete 1 set of interviews and questionnaires about GIST symptoms. In Part 2, the importance of some symptoms to patients with GIST will be rated by doctors, nurses, patients, and family caregivers. In Part 3, participants will complete questionnaires about GIST symptoms over 1 year.
You are being asked to take part in Part 3 of the study.
Detailed description
Symptom Questionnaires:
If you agree to take part in this study, you will complete questionnaires about symptoms you are having. You will be asked to fill these out 1 time a week during the first 2 months after surgery, 1 time a week during the first 3 months of a new therapy, and every 2 weeks at other times. The questionnaire will ask you to rate how severe your symptoms are and how the symptoms effect the activities of your daily life. The symptom questionnaire should take about 5 minutes to complete. You will complete the questionnaire during the first study visit and at your regular clinic visits.
Between clinic visits, you will be called every 1-2 weeks to complete the questionnaire using an automated telephone system. You can decide what time is most convenient for the automated phone system to call you. If you are not available when the automated system calls, it will call you again at a later time. If you are not reached by the automated phone system after several tries, the study staff will call you. You will be given a secure user name and identification number to use with the automated phone system. The study staff will teach you how to use the automated phone system.
At the clinic visit closest to 3 months after you start the study, you may be seen by a research staff member a second time 1 to 3 days after you completed the symptom questionnaire and asked to fill out the symptom questionnaire again. The research staff member may contact you by phone prior to this clinic visit to arrange times to meet you for the 2 assessments.
Quality-of-Life/Demographic Questionnaires:
At the first visit and the regular clinic visits, you will also rate your overall quality-of-life. This should take about 1 minute to complete.
At the first visit, you will also be asked some demographic questions (such as your age and marital status). Answering these questions should take about 1 minute.
Opinion Questionnaire:
If you are 1 of the first 40 patients enrolled in the study, you will be asked questions about your opinion of the symptom questionnaire at the clinic visit closest to 3 months after you start the study. For example, you will be asked if the symptom questionnaire was easy to understand and complete, and if there were any other questions that should be included. The study staff will use your opinion to decide if changes should be made to the questionnaire or if important symptom questions are missing from the questionnaire. This questionnaire should take about 5 minutes to complete.
Length of Study:
You will be on study for 1 year. You will be off study after you complete the last symptom questionnaire.
This is an investigational study.
Up to 188 participants will take part in this study. Up to 150 participants will be enrolled in Part 3 of this study. All will be enrolled at MD Anderson.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 | – | Behavioral: Questionnaires, Behavioral: InterviewPatient interview and developmental questionnaires |
| Part 2 | – | Behavioral: QuestionnairesContent Expert Panel (doctors, nurses) + Patients and Caregivers Questionnaire Development |
| Part 3 | – | Behavioral: MDASI-GIST QuestionnairePatient MDASI-GIST Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- UT MD Anderson Cancer Center Sarcoma and Surgical Oncology Clinics GIST Patients, their caregivers, doctors and nurses who are 18 years or older.
Key inclusion criteria (12 listed)
- 18 years of age or older (Patient and family caregiver only)
- Ability to speak and read English (All participants)
- Residing where IVR service is available (Part 3, Patient only)
- Diagnosis of GIST confirmed by pathological analysis (Patient only)
- Starting new treatment (either surgical or medical) and planning to be followed at M.D. Anderson Cancer Center (Part 3, Patient only)
Key exclusion criteria (3 listed)
- Medical condition or impaired performance status that would preclude participation in the study (Patient only)
- Diagnosis of active psychosis or severe cognitive impairment as determined by primary physician (Patient only)
- Active treatment (systemic drug therapy or radiation therapy) for a second malignancy (Patient only)
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 |
|---|---|---|
| QuestionnairesAlso: survey10 minutes to complete 3 questionnaires for development of MDASI-GIST | Behavioural | Part 1, Part 2 |
| InterviewEach interview will take approximately 30 minutes. | Behavioural | Part 1 |
| MDASI-GIST QuestionnaireAlso: surveyEvery 4 weeks for one year | Behavioural | Part 3 |
Primary outcome
Questionnaire Responses to Symptom Inventory for Gastrointestinal Stromal Tumors
Time frame: Patients will be followed on study for 1 year regardless of changes in disease stage or treatments.
Descriptive statistics used to assess the distributional characteristics and demographics of the study population and to report how patients rate symptom severity and interference with function.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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GIST
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.
Loretta A. Williams, PhD, MSN 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 Gastrointestinal Stromal Tumors, 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 12 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Jan 2020. 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?
Results are not available in the source record.
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?
Questionnaire Responses to Symptom Inventory for Gastrointestinal Stromal Tumors (time frame: Patients will be followed on study for 1 year regardless of changes in disease stage or treatments.). 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 13 Jan 2020.