Digestive System Diseases

All Conditions

Neoplasms

Behaviors and Mental Disorders

Rare Diseases

Gastroesophageal Reflux

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Quality of Life

Esophageal Cancer

Esophagectomy with pyloric drainage procedure

Esophagectomy without pyloric drainage procedure

Ten questions regarding symptoms of reflux

Telephone Questionnaire

Reza J. Mehran, MD

The purpose of the current study is to assess the role of pyloric drainage procedure on altering the reflux effect on the quality of life in patients who underwent esophagectomy. Researchers hypothesize that the patients who underwent minimally invasive esophagectomies without pyloric drainage experience less reflux symptoms and therefore have a better quality of life.

Surgery is considered curative for patients with esophageal cancer. The minimally invasive approach was developed such that laparoscopy and thoracoscopy replace large abdominal and thoracic incisions. For both open and minimally invasive procedures, patients have many adjustments to overcome in order to regain quality of life that is within the norm. In a recent study on the health-related quality of life (HRQL) after curative surgical resection, symptoms of reflux was the only variable that worsened with statistical significance.

The study plan is to retrospectively compare two groups of patients: those who underwent esophagectomy with pyloric drainage procedure and those who did not. The study will be done using all MD Anderson patients who underwent minimally invasive esophagectomies, in which pyloroplasty and pyloromyotomy are not standard procedures. Clinically relevant data and demographic information will be collected retrospectively for the two groups including age, gender, Body Mass Index, level of anastomosis, and time elapsed since surgery. All patients will be interviewed via telephone. At least two attempts will be made to contact each patient.

Quality of Life After Esophagectomy for Cancer

Role of Pyloric Drainage in Reflux Symptoms After Esophagectomy for Cancer

Comparison of reflux symptoms in patients who underwent open esophagectomies with pyloric drainage and those who received minimally invasive esophagectomies without pyloric drainage. The survey consisted of ten questions regarding symptoms associated with reflux using Gastrointestinal Symptoms Rating Scale (GSRS). Responses to degree of reflux distress rated on a six-point scale for questions with "0" indicating no heartburn symptoms and "5" indicating most symptoms experienced.

M.D. Anderson Cancer Center

Telephone questionnaire, which includes questions on participant's demographics, anxiety/depression scores, what support they find helpful and what additional support they feel would be beneficial

Telephone questionnaire

Sing Yu Moorcraft

The main questions the study aims to answer are:

1. The proportion of family members of cancer patients who say they need more support
2. What support family members feel would be beneficial

Information about patients' cancer diagnosis and treatment will be collected from their medical notes.

Participating family members will be asked to complete a telephone questionnaire. Selected family members may also be asked to participate in an optional follow-up interview.

When someone is diagnosed with cancer, it can be a worrying and stressful time for patients and for their family members. Family members may provide practical and emotional support to patients, and may take on a caregiver role.

Family members may want more information or advice, or may benefit from emotional support themselves. The study aims to identify any gaps in the current support provided to family members so that services can be improved in the future.

Oncology patients in Singleton Hospital, Swansea will be asked by their oncology team to identify one or more family members to participate in the study. If a family member agrees to participate in the study, the research team will call them to complete a telephone questionnaire. The questionnaire should take less than 20 minutes and asks them some general questions (e.g. age, gender) and some questions about how they are feeling, what support services they find helpful and what additional support they feel would be beneficial.

Data regarding participating patients' cancer diagnosis and treatment will be collected from their medical notes.

After the questionnaire data has been analysed, optional follow-up interviews will be conducted with some family members to explore any issues identified in greater detail.

Patients and family members will be recruited during a 6 month recruitment period and all responses will be anonymised.

This is a pilot study which will not change the current support provided to family members, although they may be directed to existing services if appropriate. Patients' treatment will not be changed in any way.

Mixed Methods Study to Assess Family Members Unmet Needs in an Oncology Setting

The proportion of family members who state they need more support

he proportion of family members who state they need more support with each of the Carer Support Needs Assessment Tool (CSNAT) domains

This will be determined by qualitative analysis of questionnaire and interview data and may include improved psychological support, online resources, information leaflets etc

Swansea University

Swansea Bay University Health Board

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Anti-Infective Agents

All Drugs and Chemicals

Plerixafor

Follow-Up Telephone Calls Every 6 Months for 5 Years.

Chitra M. Hosing, MD

Objectives:

The objective of this long-term observational study is to assess progression-free survival and overall survival for a period of five years following the first dose of study treatment (placebo or plerixafor \[AMD3100\]) in protocol AMD3100-3102. Patients that received at least 1 dose of study treatment (placebo or plerixafor) in the multicenter, randomized, double-blind, placebo-controlled AMD3100-3102 study, which was designed to evaluate plerixafor plus granulocyte colony stimulating factor (G-CSF) versus placebo plus G-CSF to mobilize hematopoietic stem cells for autologous transplantation of Multiple Myeloma (MM) patients are eligible.

Informed Consent Process:

Your study doctor or staff will either meet with you in person or contact you by phone to review the study information. You will be given a copy of this consent form to review and ask questions.

If you agree to take part in this study, you should sign this consent form on the date that you agree to be in the study. If you agree to take part during a phone call with a member of the study team, you should sign and date the form right away, on the date of the phone call, and mail the form to the study doctor or staff. Please keep a copy for your own reference.

5-Year Follow-Up: You will be contacted by phone or in person at a visit, every 6 months for 5 years from the time of your first study drug/placebo dose in the 2004-0982 study. A placebo is a substance that looks like the study drug but has no active ingredients.

If you received a transplant in the 2004-0982 study, your first contact in this study will either be about 18 months from the time you began the 2004-0982 study, or at the time you sign this consent form.

If you did not receive a transplant, your first contact in this study will be at the time you sign this consent form.

At your first visit or call, you will be asked about the status of the disease, any changes in the multiple myeloma that may have occurred since the 2004-0982 study, and any additional treatments you may have received during that time.

At every visit or call after that, you will be asked about the status of the multiple myeloma, any changes in the disease, and any treatments you have received since the last visit or call. These questionnaires will take about 10 minutes each time.

Your doctor or the study staff also may contact your local doctor in order to collect information from your medical records or for information about your medical history and disease status.

Length of Study Participation:

You will be off study after your last study phone call or visit (about 5 years after your first study drug/placebo dose in the 2004-0982 study).

This is an investigational study. Up to 300 patients will participate in this multi-center study. Up to 12 will be enrolled at MD Anderson.

Long-Term Follow Up Study for AMD3100 Patients

Long-Term Observational Follow-Up Study of a Multicenter, Randomized, Double-Blind, Placebo-Controlled, Comparative Trial of AMD3100 (240 MCG/KG) Plus G-CSF (10 MCG/KG) Versus G-CSF (10 MCG/KG) Plus Placebo to Mobilize and Collect >/= 6 x 10^6 CD34+ Cells/KG in Multiple Myeloma Patients for Autologous Transplantation

Progression-free survival defined as number of participants without disease progression at five years following the first dose of study treatment (placebo or plerixafor \[AMD3100\]).

Overall survival defined as number of participants alive after a period of five years following the first dose of study treatment (placebo or plerixafor \[AMD3100\]).

AnorMED

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Anti-Inflammatory Agents

Antineoplastic Agents

Antirheumatic Agents

Analgesics

Central Nervous System Stimulants

Psychotropic Drugs

Cardiotonic Agents

Curcumin

Modafinil

Bupropion

Minocycline

Antidepressive Agents

Dopamine

Dopamine Uptake Inhibitors

Dopamine Agents

Neurotransmitter Agents

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Anti-Bacterial Agents

Weeks 1-10, 2 questionnaire calls/week; and Weeks 11-16, 1 call/week.

Initial Dose 150 mg once a day (50 mg and 100 mg oral tablets) for 10 weeks.

Armodafinil

Initial Dose 100 mg two times a day (200 mg) for 10 weeks.

Initial Dose 4 gm stick pack once a day (4 gm) for 10 weeks.

Zhongxing Liao, MD

The goal of this clinical research study is to compare armodafinil, bupropion, curcumin, and minocycline when given alone or in combination to learn which is better for controlling symptoms, such as the side effects of chemoradiation, when given to treat lung cancer.

The Study Drugs:

It is not known which study drug or combination of study drugs is better at reducing side effects patients may experience during chemoradiation therapy. For this reason, researchers have chosen 4 study drugs that may help to reduce side effects. The study drugs will be tested alone and in combination with each other.

Armodafinil is designed to prevent excessive sleepiness.

Bupropion is an antidepressant with anti-inflammatory properties that may help reduce multiple symptoms.

Curcumin is the active ingredient in the spice, turmeric. It may interfere with the production of cytokines (which cause inflammation), which may reduce multiple symptoms.

Minocycline is an antibiotic. Minocycline has been shown to interrupt cytokine production, which may help to reduce multiple symptoms.

Study Groups:

If you agree to take part in this study, you will be randomly assigned (as in the roll of dice) to join 1 of 16 groups. You may be assigned to receive no study drugs, 1 study drug, or a combination of 2, 3, or all 4 of the study drugs.

During this study, you may receive 1 or more placebos. A placebo looks like the study drug(s) but has no active ingredients. There is a chance that you will be in a group that does not receive any study drugs at all. However, all patients are under standard care by their treating doctors.

Neither you nor the study staff you will see in the clinic will know if you are receiving the study drugs and/or the placebo(s). However, if needed for your safety, the study staff will be able to find out which study drug you are receiving.

Study Drug Administration:

You will take the study drugs/placebos every day for 10 weeks. You will take either single or combined study drug(s) or placebos by mouth everyday as instructed by the study doctor.

You will be given pamphlets with more information about how to take the study drugs/placebos.

You will be given a daily diary to write down when you take the study drugs/placebo. You should bring your study drug/placebo blister packs/sticks to the clinic to every study visit. You should also bring your diary to every visit.

Completing the Symptom Questionnaire:

Throughout the study, you will be asked to complete the symptom questionnaire. You will be asked about symptoms from therapy you may be experiencing and how they may be interfering with your daily activities. The study staff will either meet you during your regular clinic visit or call you at your home at a time that is convenient for you. In the clinic, you will complete the questionnaire by paper and pen, or by entering your answers into an electronic tablet computer. On the phone, study staff will ask you the questions and record your answers on paper or enter them into a computer. The symptom questionnaire will take up to 5 minutes to complete.

* During Weeks 1-10, you will complete the symptom questionnaire 2 times a week.
* During Weeks 11-16, you will complete the symptom questionnaire 1 time a week.

Study Visits:

Before you begin chemoradiation:

* You will complete 4 questionnaires about pain and other symptoms, your mood, and your quality of life. Completing all 4 of the questionnaires will take about 15 minutes.
* You will have a blood coagulation test, called a PT-INR, to make sure your blood clots normally.
* If you are a woman who is able to become pregnant, you will have a urine pregnancy test. The study staff will give you the pregnancy test kit at your scheduled visit, and will review and record the results of the test before your study prescriptions are filled by the pharmacy.

After 4 weeks of chemoradiation:

* You will complete 1 questionnaire about your quality of life. This questionnaire will take about 2-3 minutes to complete.
* You will have a blood coagulation test, called a PT-INR, to make sure your blood clots normally.

During the last week of chemoradiation (about Week 7):

-You will complete 3 questionnaires about your symptoms, mood, and quality of life. These questionnaires will take about 10 minutes total to complete.

After about Week 7, the study staff will call you 2 times a week to check on you until week 10. This phone call should last only a few minutes. If you have experienced several side effects from chemoradiation, this phone call make take longer.

About Week 12 (at a routine clinical visit):

* You will complete 3 questionnaires about your symptoms, mood, and quality of life.
* If you were smoking at the beginning of the study, you will complete a questionnaire that asks if you stopped smoking any time during the study. This will take a few minutes.
* You will have a blood coagulation test, called a PT-INR, to make sure your blood clots normally.
* You will be asked to complete another questionnaire that asks about your satisfaction with the study drug(s). This will take a few minutes.

Length of Study:

You will be on study for about 16 weeks. You will take the study drug(s) for 10 weeks and complete the symptom survey until 16 weeks. You will be taken off study if you experience intolerable side effects.

This is an investigational study. Armodafinil is FDA approved and commercially available for the treatment of excessive sleepiness. Bupropion is FDA approved and commercially available for the treatment of depression. Minocycline is FDA approved and commercially available for the treatment of bacterial infection. Curcumin is not FDA approved. At this time, curcumin is only being used in research. The different possible combinations of these drugs being used in this study is investigational.

Up to 32 patients will take part in this study. All will be enrolled at MD Anderson.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Quality of Life After Esophagectomy for Cancer	NCT00798746	Esophageal Canc...	Telephone Quest...	18 Years -	M.D. Anderson Cancer Center
Mixed Methods Study to Assess Family Members Unmet Needs in an Oncology Setting	NCT06142071	Cancer	Telephone quest...	18 Years -	Swansea Bay University Health Board
Quality of Life After Esophagectomy for Cancer	NCT00798746	Esophageal Canc...	Telephone Quest...	18 Years -	M.D. Anderson Cancer Center
Quality of Life After Esophagectomy for Cancer	NCT00798746	Esophageal Canc...	Telephone Quest...	18 Years -	M.D. Anderson Cancer Center
Mixed Methods Study to Assess Family Members Unmet Needs in an Oncology Setting	NCT06142071	Cancer	Telephone quest...	18 Years -	Swansea Bay University Health Board
Long-Term Follow Up Study for AMD3100 Patients	NCT00476294	Myeloma	Telephone Quest...	18 Years - 78 Years	M.D. Anderson Cancer Center
Reducing Symptom Burden - Non Small Cell Lung Cancer (NSCLC)	NCT01048983	Non Small Cell ...	Armodafinil Bupropion Minocycline Curcumin Telephone Quest...	18 Years - 65 Years	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for telephone questionnaire