Neoplasms

Digestive System Diseases

All Conditions

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Hematinics

All Drugs and Chemicals

Gastrointestinal Agents

Liver Extracts

Pancrelipase

Pancreatin

Questionnaire

Interview

Xin Shelley Wang, MD, MPH

The goal of this study is to learn more about the symptoms that may occur in patients with GI cancer. The types of GI cancer being studied are cancers of the stomach, liver, pancreas, colon, and rectum. Researchers want to test a newly-designed questionnaire called the M. D. Anderson Symptom Inventory - Gastrointestinal (MDASI-GI) questionnaire.

Questionnaires:

If you agree to take part in this study, you will be asked to complete the MDASI-GI questionnaire on Day 1. It asks about any symptoms you may be experiencing, and how those symptoms may be interfering with your daily life. You will also complete two questionnaires that ask about the overall quality of your life. In total, these questionnaires should take about 20 minutes to complete.

You will then complete a questionnaire that asks for demographic information such as your age and marital status. It should take about 5 minutes.

You will receive another copy of the MDAS-GI questionnaire and the quality-of-life questionnaire to take home and complete 1 week later. The research staff will call you to remind you when it is time to complete this questionnaires. You should mail it back to the study staff in a stamped, pre-addressed envelope that will be provided to you.

Evaluation of Questionnaires:

Also on Day 1, a small group of participants (25 out of the 185 total participants) will complete an additional questionnaire called a "cognitive debriefing" questionnaire. These 25 participants will be the first 5 participants to join this study who have 1 of the 5 types of cancer being studied.

The questionnaire asks questions related to how easy it was for you to answer the questions on the MDASI-GI questionnaire, whether the questions relate to the symptoms you may be experiencing, and whether any other questions should be added. This questionnaire should take about 10 minutes to complete.

Interview:

Another small group of participants (a different 25 out of the 185 total) will have a one-on-one interview with a member of the study staff. During the interview, you will be asked to further describe the symptoms you may have experienced. This interview will be scheduled for a day when you are going to be at M. D. Anderson for a routine clinic visit. It should take about 30 minutes to complete.

You and the interviewer will be the only ones in the room during the interview, and the information collected will be kept confidential. The interview will be tape-recorded.

Questionnaire and Interview Content:

Your responses will not be shared with your doctor. If you feel you need a doctor's opinion about anything that is asked about, please contact your doctor.

Information Collection:

As part of this research study, the research staff will collect information from your medical record one time. This will include data about the cancer, cancer treatment, and routine test results.

Length of Study Participation:

After you mail back the questionnaire at Week 1 (or complete it by phone interview with research staff), or after the interview if you have one, your active participation in this study will be over.

This is an investigational study. Up to 185 patients will take part in this study. All will be enrolled at M. D. Anderson.

Validating M.D. Anderson Symptom Inventory (MDASI-GI) in GI Cancer Patients Under Chemotherapy

M.D. Anderson Symptom Inventory (MDASI-GI) Validation and Clinical Utility in Patients With Gastrointestinal Cancers Being Treated or Followed by GI Medical Oncology

M.D. Anderson Cancer Center

Symptoms and General Pathology

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Neoplasm Metastasis

Head and Neck Neoplasms

Nasopharyngeal Carcinoma

Laryngeal Cancer

Hypopharyngeal Cancer

Participants randomly assigned to receive one of three sets of instructions before starting. Instructions for three swallowing exercises as well as an introductory script explaining the purpose of the exercises will be videotaped and shown to participants. Participants perform 3 swallowing exercises while researcher leaves the room. At the end of the testing period, researcher will come back into the room and record the number on participant's tracking device. Participant to tell whether they did as many repetitions as possible and if not, why they were not able to do as many as possible. This portion of the experiment will be videotaped. Participants complete an M.D. Anderson Symptom Inventory for Head and Neck Cancer Patients before procedure as well as a brief 3-page post-session questionnaire.

Participants randomly assigned to receive one of three sets of instructions before starting. Instructions for three swallowing exercises as well as an introductory script explaining the purpose of the exercises will be videotaped and shown to participants. Participants perform 3 swallowing exercises while researcher leaves the room. At the end of the testing period, researcher will come back into the room and record the number on participant's tracking device. Participants complete an M.D. Anderson Symptom Inventory for Head and Neck Cancer Patients before procedure as well as a brief 3-page post-session questionnaire.

Participants randomly assigned to receive one of three sets of instructions before starting. Instructions for three swallowing exercises as well as an introductory script explaining the purpose of the exercises will be videotaped and shown to participants. Participants perform 3 swallowing exercises while researcher leaves the room. At the end of the testing period, researcher will come back into the room and record the number on participant's tracking device. The videocamera will tape participant's session so evaluation can be made as to exercise accuracy. Participants complete an M.D. Anderson Symptom Inventory for Head and Neck Cancer Patients before procedure as well as a brief 3-page post-session questionnaire.

Participants perform 3 swallowing exercises.

Swallowing Exercises

Participants complete an M.D. Anderson Symptom Inventory for Head and Neck Cancer Patients before swallowing exercise procedure.

Symptom Inventory

Participants fill out 3 questionnaires after swallowing exercises. The questionnaires will take about 10 minutes to complete.

Questionnaires

Eileen H. Shinn, PHD, MS, BA

The goal of this research study is to look for factors that influence whether or not head and neck cancer patients follow the swallowing exercises that they are asked to perform while receiving radiation treatment.

Head and neck cancer patients who receive radiation are at risk for permanent swallowing disorders. Because of these potential problems, swallowing exercises are an important part of recovery. Researchers want to learn what factors affect how well patients follow the swallowing schedule they are given, and what can be done to make it consistent.

If you agree to take part in this study, you will have the following procedures performed.

Videotaped Swallowing Exercise:

Researchers will ask you to perform 3 swallowing exercises while being recorded by a video camera. The length of the taping session will be 3 minutes. Afterward, you will fill out 3 questionnaires. The questionnaires will take about 10 minutes to complete.

Length of Study:

You will be asked to come in 1 time for this study.

For the next 2 years, information may be collected from your medical record. This information will include the cancer stage, if the disease has gotten worse, any treatment you receive, and any side effects you experience. This information will help researchers learn how certain treatments affect patients and their risk for future disease.

This is an investigational study.

Up to 225 patient will take part in this study. All will be enrolled at MD Anderson.

Testing Accountability in Patient Adherence

Purpose of experiment is to determine whether an accountability manipulation and whether human vs technological monitoring result in higher patient adherence. Main outcome measure is perseverance of effort which will be number of repetitions within one minute interval for each exercise.

National Institute of Dental and Craniofacial Research (NIDCR)

Skin and Connective Tissue Diseases

Behaviors and Mental Disorders

Gastrointestinal Stromal Tumors

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Quality of Life

Patient interview and developmental questionnaires

Content Expert Panel (doctors, nurses) + Patients and Caregivers Questionnaire Development

10 minutes to complete 3 questionnaires for development of MDASI-GIST

Each interview will take approximately 30 minutes.

MDASI-GIST Questionnaire

Loretta A. Williams, PhD, MSN

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.

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.

Symptom Inventory for Gastrointestinal Stromal Tumors

Symptom Burden in Patients With Gastrointestinal Stromal Tumors (GISTs)

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Validating M.D. Anderson Symptom Inventory (MDASI-GI) in GI Cancer Patients Under Chemotherapy	NCT00849979	Gastrointestina...	Questionnaire Interview	18 Years -	M.D. Anderson Cancer Center
Testing Accountability in Patient Adherence	NCT01844557	Head And Neck C...	Swallowing Exer... Symptom Invento... Questionnaires	18 Years -	M.D. Anderson Cancer Center
Validating M.D. Anderson Symptom Inventory (MDASI-GI) in GI Cancer Patients Under Chemotherapy	NCT00849979	Gastrointestina...	Questionnaire Interview	18 Years -	M.D. Anderson Cancer Center
Symptom Inventory for Gastrointestinal Stromal Tumors	NCT01178307	Gastrointestina...	Questionnaires Interview MDASI-GIST Ques...	18 Years -	M.D. Anderson Cancer Center

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