Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Behaviors and Mental Disorders

Lung Neoplasms

Pleural Effusion, Malignant

Pleural Effusion

Pleural Diseases

Respiratory Tract Diseases

Quality of Life

19 question M. D. Anderson Symptom Inventory (MDASI) before pleural effusion treatment and at each follow-up visit, takes about 5 minutes to complete each time.

MDASI Questionnaire

David Ost, MD

The goal of this clinical research study is to compare 2 different methods for treating a pleural effusion. Researchers also want to learn how the treatment you receive effects your quality of life (your ability to do the things you like to do and how happy you feel.

If you agree to take part in this study, you may be asked to fill out a questionnaire called the MD Anderson Symptom Inventory (MDASI) before your scheduled pleural effusion treatment procedure, 24 hours after your procedure, and then weekly for the next 4 months. During this time, a member of the study staff or a computer system will call you at home on your desired day and time to complete the questionnaire. The MDASI for lung-related symptoms has 22 questions about the possible symptoms caused by the disease, and how the symptoms may affect the activities of your daily life, which you will rate on a scale of 0-10. The MDASI will take about 5 minutes to complete each time.

You will also complete 2 questionnaires called the SF6D Patient Self Assessment and Borg Scale before your scheduled pleural effusion treatment procedure, 2 weeks later, and then 1 time a month for 1 year. These questionnaires are part of your standard of care. There are 7 questions total about how the symptoms may affect the activities of your daily life. If you are not in the clinic, a member of the study staff will call you at home on your desired day and time to complete the questionnaires. The questionnaires should take about 5 minutes total to complete each time.

Your information will be stored in a password-protected database for use in future research related to cancer for up to 5 years after the study is completed.

Before any of your information that is stored in the database can be used for research, the people doing the research must get specific approval from the Institutional Review Board (IRB) of MD Anderson. The IRB is a committee made up of doctors, researchers, and members of the community. The IRB is responsible for protecting the participants involved in research studies and making sure all research is done in a safe and ethical manner. All research done at MD Anderson, including research involving your data from this bank, must first be approved by the IRB.

Your information will be given a code number so that none of your personal identifying information will be directly linked to your information. Only the researcher in charge of the database will have access to the code numbers and be able to link the information in the database back to you. Other researchers who use the database will not be able to link your information or file back to you.

This is an investigational study. Up to 445 participants will be enrolled at MD Anderson.

Pleural Catheters Versus Thoracoscopic Pleurodesis

Comparative Effectiveness of Indwelling Pleural Catheters Versus Thoracoscopic Pleurodesis for Treatment of Malignant Pleural Effusions

Quality-adjusted time to death (measured as QALYs) for two patient groups (indwelling pleural catheters and thoracoscopy), calculated using Brazier's SF-6D utility measure described to determine utilities, then integrating utilities over time to arrive at quality-adjusted survival for each patient.

M. D. Anderson Symptom Inventory (MDASI) symptoms questionnaire: 19 questions about symptoms rated on a scale of 1-10.

M.D. Anderson Cancer Center

Blood and Lymph Conditions

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Neoplasms by Histologic Type

Hematologic Diseases

Myeloproliferative Disorders

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Myeloid Leukemia

Chronic Graft Versus Host Disease

Chronic Myeloid Leukemia

Chronic Myeloproliferative Disorders

Patients interviews and questionnaires about CML symptoms once.

Importance of symptoms to CML patients rated by physicians, nurses, patients, and caregivers.

Patients questionnaires about CML symptoms over 1 year using M. D. Anderson Symptom Inventory (MDASI) module (the MDASI-CML)

30 Minute Interview about what it is like to have CML, followed by symptom questionnaire, quality-of-life questionnaire, and demographic questions taking another 10 minutes for all 3 questionnaires.

Interview & Questionnaires

Questionnaire developed in Part 1 to rate the relevance of symptom items, given to 3-5 physicians, 3-5 nurses, 2-4 patients and their family caregivers, taking about 10 minutes.

Rating Questionnaire

Patient questionnaires about CML symptoms over 1 year, completed in person or using Interactive Voice Response (IVR) system every 2 weeks.

MDASI-CML Questionnaire

Loretta A. Williams, PHD, MSN

Objectives:

The objective of this study is to measure and delineate the symptom burden experienced by patients with chronic myeloid leukemia (CML).

The Primary Aim is to develop and validate an M. D. Anderson Symptom Inventory (MDASI) module (the MDASI-CML), compliant with FDA standards for patient-reported outcomes (PROs), to measure the severity of multiple symptoms and the impact of these symptoms on daily functioning in patients with CML.

The Secondary Aims are:

1. to develop a detailed description of the severity and interference with daily activities of symptoms experienced by patients with CML;
2. to assess the impact of symptom severity in CML on standard functioning and quality of life (QOL) measures including Eastern Cooperative Oncology Group (ECOG) Performance Status and single-item QOL scale;
3. to evaluate the MDASI-CML as an estimate of functional status and QOL in patients with CML;
4. to identify common clusters of symptoms and symptom patterns occurring over multiple measurement time points in patients with CML;

5, to define the qualitative symptom burden of patients with CML;

6. to explore the feasibility of the Interactive Voice Response (IVR) system in measuring symptom severity and interference with daily activities over time in patients with CML.

Part 1:

Interview:

If you agree to take part in this study, while you are at the clinic for a visit, you will be interviewed about what it is like to have CML. The interview should take about 30 minutes to complete.

Questionnaires:

After the interview, you will be asked to answer a symptom questionnaire, a quality-of-life questionnaire, and some demographic questions such as your age and marital status. It will take about 10 minutes to complete all 3 questionnaires.

Length of Study:

After you have completed the interview and questionnaires, your participation on this study will be over.

Additional Information:

The interview will be digitally recorded. The electronic record of the interview will not have your name linked to it and it will be kept on a secure server at M. D. Anderson Cancer Center that is password protected. All study materials will be destroyed after data analysis is completed and study results reported.

Information about your symptoms collected in this study is collected for research purposes only. If you are experiencing severe or troublesome symptoms, you should report them to your doctor or nurse as well as rating them on the symptom assessment questionnaire. If the data collector notices that you have rated a symptom as severe, the data collector will ask you if your doctor or nurse is aware of the symptom or if you intend to report the symptom to your doctor or nurse. If you have not or do not intend to report the symptom, the data collector will let you know that he or she will report the symptom to your doctor or nurse.

This is an investigational study.

Up to 218 participants will take part in this study. Up to 40 will be enrolled in Part 1 of this study. All will be enrolled at MD Anderson.

Part 3:

Symptom Questionnaires:

If you agree to take part in this study, you will complete a questionnaire about any symptoms you are having every 2 weeks for 1 year. On the questionnaire, you will be asked to rate the level of discomfort caused by the symptoms you are having 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 clinic visits every 3 months. In between visits, you will be called every 2 weeks to complete the questionnaire by an automated telephone system.

You will decide a convenient time and place 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. You may also call the automated system if you miss a call. 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. You will be shown how the automated phone system works by the study staff.

Two (2) days after the first visit, you will fill out the symptom questionnaire again. You will take it home with you from the clinic with a pre-addressed, stamped envelope given to you by the research staff so you can return it. The research staff will also ask for your telephone number so that they may contact you and remind you to complete the questionnaire.

Quality-of-Life/Demographic Questionnaires:

At the first visit and the 3-month 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 30 patients enrolled in the study, at the first visit you will also complete a questionnaire about your opinion of the symptom questionnaire. For example, you will be asked if the symptom questionnaire was easy to understand and to complete and if there were any other questions that should be included. The study staff will use your opinion to decide if other 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.

Additional Information:

The questionnaires will only use your study number and will not have your name linked to them. All questionnaires and study data will be kept in a locked cabinet at all times. All study materials will be destroyed after data analysis is completed and study results reported.

Information about your symptoms collected in this study is collected for research purposes only. If you are experiencing severe or troublesome symptoms, you should report them to your doctor or nurse as well as rating them on the symptom assessment questionnaire. If the data collector notices that you have rated a symptom as severe, the data collector will ask you if your doctor or nurse is aware of the symptom or if you intend to report the symptom to your doctor or nurse. If you have not or do not intend to report the symptom, the data collector will let you know that he or she will report the symptom to your doctor or nurse.

This is an investigational study.

Up to 218 participants will take part in this study. Up to 160 participants will be enrolled in Part 3 of this study. All will be enrolled at MD Anderson.

Symptom Burden in Chronic Myeloid Leukemia (CML)

Symptom Burden of Patients With Chronic Myeloid Leukemia (CML)

Novartis Pharmaceuticals

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Ovarian Cancer

Ovarian Epithelial Cancer

1-on-1 interview + Questionnaires, Part 1 of Study

1-on-1 interview with study doctor or staff member, during regularly scheduled, standard of care clinic visit taking 30 minutes.

Interview

Complete 3 Questionnaires during clinic visit, about 10 minutes to complete all.

Survey

Diane C. Bodurka, MD, BS

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.

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:

1. 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.
2. 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 title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pleural Catheters Versus Thoracoscopic Pleurodesis	NCT01117740	Lung Cancer	MDASI Questionn...	18 Years -	M.D. Anderson Cancer Center
Symptom Burden in Chronic Myeloid Leukemia (CML)	NCT01046305	Leukemia	Interview & Que... Rating Question... MDASI-CML Quest...	18 Years -	M.D. Anderson Cancer Center
Pleural Catheters Versus Thoracoscopic Pleurodesis	NCT01117740	Lung Cancer	MDASI Questionn...	18 Years -	M.D. Anderson Cancer Center
Pleural Catheters Versus Thoracoscopic Pleurodesis	NCT01117740	Lung Cancer	MDASI Questionn...	18 Years -	M.D. Anderson Cancer Center
M. D. Anderson Symptom Inventory - Ovarian Cancer	NCT01037751	Ovarian Cancer	Interview Survey	18 Years -	M.D. Anderson Cancer Center

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