Ovarian CancerNCT01037751
M. D. Anderson Symptom Inventory - Ovarian Cancer
An observational study of Ovarian Cancer, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial summary
Objectives: The objective of this study is to delineate and measure the symptom burden experienced by patients with ovarian cancer. The Primary Aim is to develop and validate an ovarian-cancer module of the M. D. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Interview and Survey
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 158 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Dec 2009to 18 Jul 2018
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: UT MD Anderson Cancer Center ovarian cancer patients, females over the age of 18 years.
Who may be able to join
- Female patients 18 years of age or older.
- Able to speak and read English.
- Having a diagnosis of high grade invasive epithelial ovarian cancer, peritoneal cancer or fallopian tube cancer confirmed by pathological analysis.
- Being followed at M D Anderson Cancer Center and Lyndon B. Johnson General Hospital (LBJ Hospital).
- Has consented to participate.
- Has not received any current cancer treatment or prior chemotherapy in the last 30 days (phase 2 subset of 40 patients only)
Who cannot join
- 1) Having a medical condition or impaired performance status that would preclude participation in the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lyndon B. Johnson General Hospital
Houston, Texas, 77026
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: M. D. Anderson Symptom Inventory - Ovarian Cancer: Development and Validation in Patients With Ovarian Cancer
Objectives:
The objective of this study is to delineate and measure the symptom burden experienced by patients with ovarian cancer.
Read more
The Primary Aim is to develop and validate an ovarian-cancer module of the M. D. Anderson Symptom Inventory (MDASI-Ovarian Cancer) to measure the severity of multiple symptoms and the impact of these symptoms on daily functioning in patients with ovarian cancers.
The Secondary Aims are:
To develop a detailed description of symptom severity and interference with daily activities experienced by patients with ovarian cancer; To assess the impact of symptom severity on standard functioning and quality of life (QOL) measures, including Eastern Cooperative Oncology Group Performance Status (ECOG PS), Functional Assessment of Cancer Therapy-Ovary (FACT-O), and a single-item QOL scale, in patients with ovarian cancer; To define the qualitative symptom burden of patients with ovarian cancer receiving various treatments.
Read the detailed description
PART 1:
Interview:
If you agree to take part in this study, you will be interviewed about what it is like to have ovarian cancer and any symptoms that you may have experienced. This will be a 1-on-1 interview with the study doctor or a member of the study staff. It will take place during 1 of your regularly scheduled, standard of care clinic visit and should take about 30 minutes to complete.
The interview will be digitally recorded. The electronic recording of the interview will be given a code number and stored on a password-protected computer at M. D. Anderson. No identifying information will be directly linked to your interview recording. Only the researcher in charge of the computer will have access to the code numbers and be able to link the interview recording to you.
Questionnaires:
After the interview, you will also complete a symptom questionnaire, a quality-of-life questionnaire, and a demographic questionnaire that asks questions about your age, race, and marital status. You will complete the questionnaires after the interview during the same clinic visit. It should take about 10 minutes to complete all 3 questionnaires.
You should contact the study doctor or study nurse right away if at any time you are experiencing severe, troublesome, or intolerable symptoms. You should also remember to rate them on the symptom questionnaire.
The questionnaires will also be given a code number and stored in a locked file cabinet at MD Anderson. No identifying information will be directly linked to your questionnaires. Only the researcher in charge of the study will have access to the code numbers and be able to link the questionnaires to you.
Length of Study:
After you have completed the interview and the questionnaires, your participation on this study will be over.
Additional Information:
Any information about your symptoms that is collected as part of this study is for research purposes only. All study materials, including the interview recording and questionnaires, will only be used for the purposes of this study and will be destroyed after the study results have been reported.
If you rate a symptom as severe on the symptom questionnaire, a study staff member will ask you if you have already told, or plan to tell your regular care doctor or nurse about the symptom. If you have not already told you regular care doctor or nurse, a study staff member will tell your regular care doctor or nurse about the symptom for you.
This is an investigational study.
Up to 15 participants will take part in this study. All will be enrolled at MD Anderson.
PART 2:
Questionnaires:
If you agree to take part in this study, you will complete the following:
- A symptom questionnaire, 2 quality-of-life questionnaires, and a demographic questionnaire that asks questions about your age, race, and marital status. It should take about 20 minutes to complete all 4 questionnaires.
- About 1 to 5 days after you complete the first set of questionnaires, you will be asked to complete a questionnaire either through phone interview with the study staff or through a mail-in survey . If you complete the questionnaire by mail-in survey, the study staff will give you a copy of the questionnaire and a stamped pre-addressed envelope. The questionnaire will take 5-10 minutes to complete.
You should contact the study doctor or study nurse right away if at any time you are experiencing severe, troublesome, or intolerable symptoms. You should also remember to rate them on the symptom questionnaire.
The questionnaires will be given a code number and stored in a locked file cabinet at M. D. Anderson. No identifying information will be directly linked to your questionnaires. Only the researcher in charge of the study will have access to the code numbers and be able to link the questionnaires to you.
Opinion Questionnaire:
If you are one of the first 20 patients enrolled in the study, you will be asked questions about your opinion of the symptom questionnaire. 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:
After you have completed the questionnaires, your participation on this study will be over.
Additional Information :
Any information about your symptoms that is collected as part of this study is for research purposes only. The questionnaires will only be used for the purposes of this study and will be destroyed after the study results have been reported.
If you rate a symptom as severe on the symptom questionnaire, a study staff member will ask you if you have already told, or plan to tell your regular care doctor or nurse about the symptom. If you have not already told you regular care doctor or nurse, a study staff member will tell your regular care doctor or nurse about the symptom for you.
This is an investigational study.
Up to 128 participants will take part in this study. All will be enrolled at MD Anderson and Lyndon B. Johnson General Hospital.
- Conditions
- Ovarian Cancer
- Being tested
- Interview, Survey
- Keywords
- Cancer, Symptom burden, M. D. Anderson Symptom Inventory, MDASI-Ovarian Cancer, Symptoms, Daily functioning, Symptom severity, Questionnaire, Interview
- Medical subject headings
- Ovarian Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewBehavioural
1-on-1 interview with study doctor or staff member, during regularly scheduled, standard of care clinic visit taking 30 minutes.
SurveyBehavioural
Also called Questionnaire
Complete 3 Questionnaires during clinic visit, about 10 minutes to complete all.
| Study group | Role | What they receive |
|---|---|---|
| Interview + Questionnaires | 1-on-1 interview + Questionnaires, Part 1 of Study Receives: Behavioral: Interview; Behavioral: Survey | |
| Questionnaires | Questionnaires Only, Part 2 of Study Receives: Behavioral: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validate ovarian-cancer module of MDASI-Ovarian Cancer to measure severity of multiple symptoms + impact of these symptoms on daily functioning in patients with ovarian cancers.
Measured: Baseline to 2 years (Patient participation done after completing Interview and Surveys during single clinic visit)
Secondary outcomes (1)
Patient Rated Symptom Severity and Interference with Function (Survey Response)
Measured: Baseline to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study start30 Dec 2009
- Primary completion18 Jul 2018
- Study completion18 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies 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
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Diane C. Bodurka, MD, BS, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01037751
- Sponsor's protocol ID
- 2009-0506
- Status last verified
- Jul 2018
- First submitted
- 17 Dec 2009
- Last updated
- 1 Aug 2018
- 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 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- M. D. Anderson Symptom Inventory - Ovarian Cancer: Development and Validation in Patients With Ovarian Cancer
- ClinicalTrials.gov ID
- NCT01037751
- Acronym / sponsor ID
- 2009-0506
- Conditions
- Ovarian Cancer
- Keywords
- Cancer, Symptom burden, M. D. Anderson Symptom Inventory, MDASI-Ovarian Cancer, Symptoms, Daily functioning, Symptom severity, Questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 30 Dec 2009 (actual)
- Primary completion
- 18 Jul 2018 (actual)
- Study completion
- 18 Jul 2018 (actual)
- First posted
- 23 Dec 2009 (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.
Objectives:
The objective of this study is to delineate and measure the symptom burden experienced by patients with ovarian cancer.
The Primary Aim is to develop and validate an ovarian-cancer module of the M. D. Anderson Symptom Inventory (MDASI-Ovarian Cancer) to measure the severity of multiple symptoms and the impact of these symptoms on daily functioning in patients with ovarian cancers.
The Secondary Aims are:
To develop a detailed description of symptom severity and interference with daily activities experienced by patients with ovarian cancer; To assess the impact of symptom severity on standard functioning and quality of life (QOL) measures, including Eastern Cooperative Oncology Group Performance Status (ECOG PS), Functional Assessment of Cancer Therapy-Ovary (FACT-O), and a single-item QOL scale, in patients with ovarian cancer; To define the qualitative symptom burden of patients with ovarian cancer receiving various treatments.
Detailed description
PART 1:
Interview:
If you agree to take part in this study, you will be interviewed about what it is like to have ovarian cancer and any symptoms that you may have experienced. This will be a 1-on-1 interview with the study doctor or a member of the study staff. It will take place during 1 of your regularly scheduled, standard of care clinic visit and should take about 30 minutes to complete.
The interview will be digitally recorded. The electronic recording of the interview will be given a code number and stored on a password-protected computer at M. D. Anderson. No identifying information will be directly linked to your interview recording. Only the researcher in charge of the computer will have access to the code numbers and be able to link the interview recording to you.
Questionnaires:
After the interview, you will also complete a symptom questionnaire, a quality-of-life questionnaire, and a demographic questionnaire that asks questions about your age, race, and marital status. You will complete the questionnaires after the interview during the same clinic visit. It should take about 10 minutes to complete all 3 questionnaires.
You should contact the study doctor or study nurse right away if at any time you are experiencing severe, troublesome, or intolerable symptoms. You should also remember to rate them on the symptom questionnaire.
The questionnaires will also be given a code number and stored in a locked file cabinet at MD Anderson. No identifying information will be directly linked to your questionnaires. Only the researcher in charge of the study will have access to the code numbers and be able to link the questionnaires to you.
Length of Study:
After you have completed the interview and the questionnaires, your participation on this study will be over.
Additional Information:
Any information about your symptoms that is collected as part of this study is for research purposes only. All study materials, including the interview recording and questionnaires, will only be used for the purposes of this study and will be destroyed after the study results have been reported.
If you rate a symptom as severe on the symptom questionnaire, a study staff member will ask you if you have already told, or plan to tell your regular care doctor or nurse about the symptom. If you have not already told you regular care doctor or nurse, a study staff member will tell your regular care doctor or nurse about the symptom for you.
This is an investigational study.
Up to 15 participants will take part in this study. All will be enrolled at MD Anderson.
PART 2:
Questionnaires:
If you agree to take part in this study, you will complete the following:
- A symptom questionnaire, 2 quality-of-life questionnaires, and a demographic questionnaire that asks questions about your age, race, and marital status. It should take about 20 minutes to complete all 4 questionnaires.
- About 1 to 5 days after you complete the first set of questionnaires, you will be asked to complete a questionnaire either through phone interview with the study staff or through a mail-in survey . If you complete the questionnaire by mail-in survey, the study staff will give you a copy of the questionnaire and a stamped pre-addressed envelope. The questionnaire will take 5-10 minutes to complete.
You should contact the study doctor or study nurse right away if at any time you are experiencing severe, troublesome, or intolerable symptoms. You should also remember to rate them on the symptom questionnaire.
The questionnaires will be given a code number and stored in a locked file cabinet at M. D. Anderson. No identifying information will be directly linked to your questionnaires. Only the researcher in charge of the study will have access to the code numbers and be able to link the questionnaires to you.
Opinion Questionnaire:
If you are one of the first 20 patients enrolled in the study, you will be asked questions about your opinion of the symptom questionnaire. 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:
After you have completed the questionnaires, your participation on this study will be over.
Additional Information :
Any information about your symptoms that is collected as part of this study is for research purposes only. The questionnaires will only be used for the purposes of this study and will be destroyed after the study results have been reported.
If you rate a symptom as severe on the symptom questionnaire, a study staff member will ask you if you have already told, or plan to tell your regular care doctor or nurse about the symptom. If you have not already told you regular care doctor or nurse, a study staff member will tell your regular care doctor or nurse about the symptom for you.
This is an investigational study.
Up to 128 participants will take part in this study. All will be enrolled at MD Anderson and Lyndon B. Johnson General Hospital.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interview + Questionnaires | – | Behavioral: Interview, Behavioral: Survey1-on-1 interview + Questionnaires, Part 1 of Study |
| Questionnaires | – | Behavioral: SurveyQuestionnaires Only, Part 2 of Study |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- UT MD Anderson Cancer Center ovarian cancer patients, females over the age of 18 years.
Key inclusion criteria (6 listed)
- Female patients 18 years of age or older.
- Able to speak and read English.
- Having a diagnosis of high grade invasive epithelial ovarian cancer, peritoneal cancer or fallopian tube cancer confirmed by pathological analysis.
- Being followed at M D Anderson Cancer Center and Lyndon B. Johnson General Hospital (LBJ Hospital).
- Has consented to participate.
Key exclusion criteria (1 listed)
- 1) Having a medical condition or impaired performance status that would preclude participation in the study.
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 |
|---|---|---|
| Interview1-on-1 interview with study doctor or staff member, during regularly scheduled, standard of care clinic visit taking 30 minutes. | Behavioural | Interview + Questionnaires |
| SurveyAlso: QuestionnaireComplete 3 Questionnaires during clinic visit, about 10 minutes to complete all. | Behavioural | Interview + Questionnaires, Questionnaires |
Primary outcome
Validate ovarian-cancer module of MDASI-Ovarian Cancer to measure severity of multiple symptoms + impact of these symptoms on daily functioning in patients with ovarian cancers.
Time frame: Baseline to 2 years (Patient participation done after completing Interview and Surveys during single clinic visit)
1 secondary outcome
Patient Rated Symptom Severity and Interference with Function (Survey Response)
Time frame: Baseline to 2 years
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 2018.
- University of Texas 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. This study is not recruiting at the moment.
Diane C. Bodurka, MD, BS principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by M.D. Anderson Cancer Center at 2 sites 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 6 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: finished, as of the sponsor's last update on 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Validate ovarian-cancer module of MDASI-Ovarian Cancer to measure severity of multiple symptoms + impact of these symptoms on daily functioning in patients with ovarian cancers. (time frame: Baseline to 2 years (Patient participation done after completing Interview and Surveys during single clinic visit)). 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 2018.