Participants will return with the caregiver on day 15 to complete a questionnaire lasting 30 minutes.

Standard Care + Interactive Voice Response (IVR) System Participants will return with the caregiver on day 15 to complete a questionnaire lasting 30 minutes. Phone calls made once daily, each taking about 3-5 minutes to complete.

Phone calls made once daily, each taking about 3-5 minutes to complete.

Interactive Voice Response System

Standard Care

Sriram Yennurajalingam, MD

The goal of this research study is to learn if using an Interactive Voice Response (IVR) system can bring about better and more timely symptom control for patients with advanced cancer.

Primary Objectives:

* To determine whether the Interactive Voice Response (IVR) system, supplemented by Nursing Telephone Intervention (NTI), results in better symptom management and quality of life than standard care for individuals with advanced cancer as evidenced by reduced scores on symptom measures.
* To determine whether the IVR system, supplemented by NTI, results in reduced caregiver burden, increased caregiver satisfaction with care, and improved coping strategies.
* To determine the feasibility of using an IVR system, supplemented by NTI, for symptom assessment in individuals with advanced cancer and their caregivers by conducting a process evaluation of the system. Variables to be evaluated include rates of participant recruitment and retention, frequency of use of the system, acceptability of the system to participants, and barriers to participation. Researchers' goal is to identify and improve aspects that affect external validity (recruitment rate, cohort maintenance), internal validity (implementation, contamination), participant acceptability and satisfaction, and reaction to study procedures. The findings from this evaluation will also allow researchers to evaluate delivery of interventions in future studies.

If you and your caregiver agree to take part in this study, you will be randomly assigned (as in the toss of the coin) to be in 1 of 2 groups. Group A will receive standard of care provided at the palliative center at M. D. Anderson, but will not receive any phone calls from the Interactive Voice Response (IVR) system. Group B will receive phone calls by the Interactive Voice Response (IVR) system on Monday, Wednesday, and Friday for 15 days.

Once you sign this consent form, you will answer questions about your diagnosis, the medication that you take, and the symptoms that you are having (for example, pain, fatigue, anxiety, depression, and overall feeling of well-being). You will either be asked these questions verbally or you will complete a written questionnaire. This should take about 30 minutes to complete.

If you and your caregiver are assigned to Group A, you will continue with the standard of care provided at the palliative center at M. D. Anderson. On Day 15, both you and your caregiver will be seen in the outpatient clinic by the research nurse, and complete the same questionnaire you had at the beginning of the study, either verbally or written. This should take about 30 minutes to complete.

If you and your caregiver are assigned to Group B, a research nurse will train you and your caregiver to operate the IVR system. The IVR call will be made to the preferred telephone number(s) provided by you and your caregiver. The telephone calls will be made 1 time a day at times chosen by you and your caregiver. You will both be given a 3-digit code number to enter as a way of confirming who you are.

Once you have entered the requested numbers, the IVR system will ask you to answer questions about pain, fatigue, anxiety, depression, and your overall feeling of well-being. These phone calls should take about 3-5 minutes to complete. You should complete the phone calls separately and should not attempt to influence each others answers.

A research nurse will review the answer in the IVR system. If you haven't responded to the IVR questions in 3 days, if you answer that you would like to be contacted by a nurse, or if a symptom has reached a concerning level, you and your caregiver will receive a phone call from the nurse. The nurse may ask about symptoms, medications being taken, concerns or doubts about the medication, and if you have any concerns about your physical or emotional well being. You will be reminded of the different telephone numbers you can use to receive assistance 24 hours a day. During the phone call, you will also be asked if you would like the nurse to contact your caregiver for information and support. If you agree, the nurse will contact your caregiver.

On Day 8, both you and your caregiver will be contacted either in person or by phone by the research nurse and will complete the same questionnaire you had at the beginning of the study. On Day 15, both you and your caregiver will be seen in the outpatient clinic by the research nurse and will complete this same questionnaire again, either verbally or written. This should take about 30 minutes to complete each time.

Your participation on this study will end on Day 15.

This is an investigational study. Up to 68 patient-caregiver groups (or a total of 136 participants) will take part in this study. All the participants will be enrolled at M. D. Anderson.

Interactive Voice Response System in Advanced Cancer Patients

Symptom Assessment in Advanced Cancer Patients Using an Interactive Voice Response (IVR) System

M.D. Anderson Cancer Center

Behaviors and Mental Disorders

All Conditions

Depressive Disorder

Depression

Behavioral Symptoms

Symptom information will be collected using an automated telephone system, approximately 5 minutes per week.

Telephone Intervention

3 questionnaires and one-on-one interviews during 3 regularly scheduled clinic visits.

Questionnaires & Interviews

Tito Mendoza, BS,MED,MS,PHD

The goal of this research study is to learn how well a telephone system works for improving the management of emotional distress, sadness, and/or depression in patients who are being treated for cancer.

Study Groups:

If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups: telephone intervention or standard care. You have an equal chance of being assigned to either group.

No matter which group you are assigned to, you will be asked to tell your doctor and/or nurse about all symptoms you may be experiencing during your regularly scheduled visits. You will also be asked to call your doctor and/or nurse right away when your symptoms are severe. The doctor and/or nurse will give you instructions about calling when your symptoms are severe.

You will receive educational material about emotional distress, sadness, and depression in people who are being treated for cancer. The material also will tell you about community resources that are available for people with cancer.

Feedback Group:

If you are assigned to the feedback group, your symptom information will be collected using a telephone system. You will be asked to rate 13 symptoms, such as sadness, emotional distress, and fatigue, on a scale of 0 to 10 using the touch tone key pad of your telephone. The 0 means that you are not having the symptom at all, and the 10 means that the symptom is as bad as you can imagine.

If you rate either of the 2 symptoms of sadness and/or emotional distress as moderate or severe, then the telephone system will send a message to the research staff and your doctor or nurse right away. Only the symptoms of sadness and emotional distress will be reported right away to the doctor or nurse and the research staff. If you answer moderate to severe to any other questions, it will not be sent right away to the doctor, nurse or study staff. The telephone system usually works very well. But, if for any reason the telephone system is not working, the research staff will report any moderate or severe sadness or distress to your doctor or nurse. Your doctor or nurse also will receive a written summary of your symptom ratings before your next clinic visit.

Standard Care Group:

If you are assigned to the standard care group, your symptom information will not be collected using the telephone system. You will be asked to tell your doctor and/or nurse about all symptoms you may be experiencing.

Telephone System:

For patients in the feedback group, the research staff will teach you how to use a telephone system for measuring your symptoms. The research staff also will ask you to practice using the telephone system. The telephone system will call you 1 time a week for 16 weeks. You will be asked to rate your symptoms and how much the symptoms interfere with your life. You can set up a time to receive the phone calls that works best for you. Rating your symptoms using the telephone system will take about 5 minutes for each call.

If you do not answer the telephone system on the first call, then the system will try to reach you 3 more times. If you do not answer after the fourth try, then the research staff will call you to find out why you could not answer the telephone system. If you prefer, the research staff will change the day or time that the telephone system calls you.

Questionnaires and Interviews:

You will be asked to fill out 3 questionnaires during 3 regularly scheduled clinic visits. These questionnaires ask questions about pain, stress, sadness, quality of life, and other symptoms you may be experiencing. You will also compete an interview at the first and third visit. During the interview, you will be asked questions about your feelings and emotions. The questionnaires and interview will be completed at the following times:

* At the first visit when you enroll in the study, 8-10 weeks after the study begins, and 14-16 weeks after the study begins, you will complete the questionnaires. This will take about 45 minutes.
* At the first visit and 14-16 weeks after the study begins, you will complete a short interview. Completing the interview will take about 15 minutes.

Length of Study:

Your participation in this study will last up to 16 weeks.

This is an investigational study.

Up to 166 patients will take part in this study. All will be enrolled at MD Anderson.

Identification and Treatment of Depression

Identification and Treatment of Depression in Underserved African American and Latino Patients With Cancer

Robert Wood Johnson Foundation

Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Pain

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Patients diagnosed with multiple myeloma (MM) complete questionnaires with Neurocognitive Testing and Neurosensory Testing

Questionnaires measuring pain and other symptoms, mood, and quality of life.

Questionnaire

A neurocognitive exam (tests to check your memory and thinking abilities, for example) will be performed.

Neurocognitive Testing

Neurosensory testing will be performed to find out how sensitive you are to things such as touch, coolness, warmth, pinprick on the finger, and squeezing of the skin on the finger, hand, or arm.

Neurosensory Testing

Xin Shelley Wang, MD

The goal of this research study is to learn about the pain and/or other symptoms that patients may experience either while you are being monitored by your doctor before a decision is made to start you on treatment for your MM, or during and after treatment for MM, and how these symptoms may affect therapy. A second goal is to learn how differences in genes may affect the symptom burden from cancer and cancer therapy.

If you agree to take part in this study, you will complete 5 questionnaires during a regularly scheduled clinic visit. These questionnaires will measure pain and other symptoms, such as your mood and quality of life. You will also be asked to give a tissue sample by inserting a swab into your mouth and rubbing firmly against the inside of your cheek or underneath your lower or upper lip for about a minute at most. Completing the 5 questionnaires and the swab sample collection takes about 30 minutes in total.

This is an investigational study.

Up to 500 patients will take part in the cross-sectional phase of this study. All will be enrolled at MD Anderson.

Tissue sample by inserting a swab into mouth and rubbing firmly against the inside of cheeck or underneath lower or upper lip for about a minute during a regularly schedule clinic visit.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Interactive Voice Response System in Advanced Cancer Patients	NCT00625638	Advanced Cancer	Interactive Voi... Standard Care	18 Years -	M.D. Anderson Cancer Center
Interactive Voice Response System in Advanced Cancer Patients	NCT00625638	Advanced Cancer	Interactive Voi... Standard Care	18 Years -	M.D. Anderson Cancer Center
Identification and Treatment of Depression	NCT00863200	Cancer	Telephone Inter... Questionnaires ...	18 Years -	M.D. Anderson Cancer Center
Interactive Voice Response System in Advanced Cancer Patients	NCT00625638	Advanced Cancer	Interactive Voi... Standard Care	18 Years -	M.D. Anderson Cancer Center
Inflammatory Cytokines in Symptom Production in Multiple Myeloma	NCT00688168	Multiple Myelom...	Questionnaire Neurocognitive ... Neurosensory Te...	18 Years -	M.D. Anderson Cancer Center

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