Symptoms and General Pathology

All Conditions

Neoplasms

Mouth and Tooth Diseases

Digestive System Diseases

Pain

Head and Neck Neoplasms

Stomatitis

Mucositis

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

This study examines whether the smartphone OM Pain App is a feasible and valid tool to assess pain from radiation-induced oral mucositis.

Each study participant will be issued an Android smartphone, or he or she may use his/her own compatible device (whether or not it has an active data service) to which the OM Pain App will be downloaded and installed. Subjects will receive a preprogrammed alarm four times a day from their smartphones prompting them to directly enter OM pain levels on the device. Patients may submit as many pain entries as they wish beyond the four minimum levels.

Subjects will receive a preprogrammed alarm four times a day from their smartphones prompting them to directly enter OM pain levels on the device. Patients may submit as many pain entries as they wish beyond the four minimum levels.

OM Pain App

Each patient will be issued an accelerometer and will be encouraged to wear it continuously during the study period (weekly during radiation therapy and four weeks following radiation therapy).

Accelerometer

Stuart J Wong, MD

This research is being done to evaluate whether or not the Oral Mucositis (OM) Pain App (a smartphone application) is a feasible and valid tool to assess pain from radiation sores (also referred to as "mucositis") when treating head and neck cancers with radiation. The mobile app will be designed to help people better understand the pain from the radiation sores.

OVERVIEW: This is a single-arm, observational, supportive care clinical trial for patients with tumors involving the oral cavity, oropharynx, or unknown primary expecting to receive at least a 50 Gy dose of definitive radiation therapy.

OM PAIN APP (DESCRIPTION): The Oral Mucositis (OM) PAIN APP (App) is a smartphone application that was designed to permit patients to key in pain severity, using a visual analog 0-10 scale. The App is programed with an alarm to prompt the patient to record pain severity at prescribed intervals daily and through spontaneous patient input. Data collected on each patient's smartphone can be backed up wirelessly to a central server where the data can be analyzed remotely or data can be viewed on the device. The software is capable of generating a time-weighted measure of pain, total area under the pain cure (AUC), a summary measure that integrates serial assessments of a patient's pain over the duration of the study.

DAILY OBSERVATION: Subjects will receive a preprogrammed alarm four times a day from their smartphones prompting them to directly enter OM pain levels on the device. Patients may submit as many pain entries as they wish beyond the four minimum levels. Data recording will not commence until radiation starts. Because symptoms of mucositis do not commence typically until the third week of radiation therapy, and no sooner than week 2, recordings from week 1 will be used for baseline data. Recording of data will cease four weeks after the end of radiation therapy at which time mucositis symptoms typically start to resolve and pain symptoms substantially abate.

ACCELEROMETER: Each patient will be issued an accelerometer and will be encouraged to wear it continuously during the study period. To help determine whether decline in physical activity is associated with severity of pain, physical activity will be assessed directly with accelerometers (activity monitor). Participants will wear an accelerometer during sleep and waking hours, but not while bathing, starting one week prior to the start radiation therapy. Accelerometer output data will be obtained in 1-minute epochs that will be then summed to provide raw daily average activity units, which will be subsequently divided by 1000 for clarity. Data will by synced weekly by the study coordinator to a computer connected to a central server.

Smartphone Pain App for Assessing Oral Mucositis Pain in Patients

Smartphone Pain App for Assessing Oral Mucositis Pain in Patients Receiving Head and Neck Radiation Therapy

The study coordinator will download data and check the equipment weekly for proper functioning and compliance. Patients will be interviewed weekly to assure the device is functioning correctly and that data is being recorded.

Stuart Wong

Professor, Department of Medicine, Division of Hematology/Oncology

Blood and Lymph Conditions

Immune System Diseases

Nervous System Diseases

Rare Diseases

Sarcoma

Lymphoma

Frailty

Hodgkin Disease

Central Nervous System Neoplasms

Nervous System Neoplasms

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Soft Tissue Sarcoma

Lymphosarcoma

Hodgkin Lymphoma

Patients utilize smartphone application to monitor physical activity and mobility up to 180 days during treatment or post-treatment.

Smartphone Application

Michael Roth, MD

This study attempts to learn more about the activity levels of adolescent and young adult (AYA) cancer patients or survivors at risk for cardiovascular morbidity and frailty by using a smartphone application called Beiwe. Collecting activity level data on AYA cancer patients or survivors may help patients achieve better quality of life.

PRIMARY OBJECTIVES:

I. To characterize patient mobility over time based upon smartphone sensor data, including dwell time at home and hospital, as well as time spent away from home or hospital, considering patients actively undergoing treatment (time referenced to treatment start) separately from those following treatment (time referenced to treatment end).

II. To characterize patient physical activity over time based upon smartphone sensor data, during and following treatment (separately), including inactivity time and activity level, at home and hospital and away from home or hospital, considering patients actively undergoing treatment (time referenced to treatment start) separately from those following treatment (time referenced to treatment end).

SECONDARY OBJECTIVES:

I. To characterize patient mobility over time based upon smartphone sensor data, including dwell time at home and hospital, as well as time spent away from home or hospital, considering patients actively undergoing treatment (time referenced to treatment start) separately from those following treatment (time referenced to treatment end), grouped by disease and treatment (chemotherapy, radiotherapy), controlling for age, sex, race, and body mass index (BMI).

II. To characterize patient physical activity over time based upon smartphone sensor data during and following treatment (separately), including inactivity time and activity level, at home and hospital and away from home or hospital, considering patients actively undergoing treatment (time referenced to treatment start) separately from those following treatment (time referenced to treatment end), grouped by disease and treatment (chemotherapy, radiotherapy), controlling for age, sex, race, and BMI.

OUTLINE:

Patients utilize smartphone application to monitor physical activity and mobility up to 180 days during treatment or post-treatment.

Mobility and Physical Activity in Adolescent and Young Adult Cancer Patients or Survivors at Risk for Cardiovascular Morbidity and Frailty, The MOBILE AYA Study

A Study to Digitally Phenotype Mobility and Physical Activity in Adolescent and Young Adult (AYA) Patients at Risk for Cardiovascular Morbidity and Frailty: MOBILE AYA

Will be analyzed by linear mixed-effect models with relation to time point (30, 60, 90, 120, 150, and 180 days), blocking on patient, with differences among time points assessed by Tukey-adjusted contrasts.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Participants given an activity tracker at the given an accelerometer at each visit. Participants instructed in use of a smartphone application at the baseline visit.

Participant emailed electronic newsletters to read that may help participant be more physically active.

Research staff provides telephone counseling to participant and partner biweekly during weeks 1-8 (weeks 1, 3, 5, and 7), and monthly during weeks 9-16 (weeks 11 and 15).

Study visits performed 2 times (1 time at the beginning of the study, and 1 time 16 weeks after beginning the study).

Participants complete questionnaires 1 time at the beginning of the study, 8 weeks after joining the study, and 16 weeks after beginning the study.

Participants invited to take part in a final focus group sometime after the 16-week visit.

Participants sent electronic newsletters throughout the study that may help participant be more physically active.

Study visits performed 2 times (1 time at the beginning of the study, and 1 time 16 weeks after beginning the study).

Participants complete questionnaires 1 time at the beginning of the study, 8 weeks after joining the study, and 16 weeks after beginning the study.

Participants invited to take part in a final focus group sometime after the 16-week visit.

Group 1 - Intervention: Participants given an accelerometer at each visit. Participant wears the accelerometer for 7 days.

Group 2 - Newsletters: After completing the 16 week visit, participant given an activity tracker.

Activity Tracker

Group 1 - Intervention: Participant given smartphone application baseline visit to track physical activity, connect with participant's partner to share information about participant's physical activity, and provide support to partner to be more physically active.

Group 2 - Newsletters: After completing the 16 week visit, participant given instruction in the use of a smartphone application.

Participants complete questionnaires about feelings, moods, motivation for physical activity, any social support received from others, the neighborhood participant lives in, and other physical activity-related topics. Questionnaires completed 1 time at the beginning of the study, 8 weeks after joining the study, and 16 weeks after beginning the study.The questionnaires should take about 45 minutes to complete.

Questionnaires

Participants invited to take part in a final focus group. Focus group takes place sometime after the 16-week visit. Focus groups/interviews are audio recorded.

Focus Group

Participant emailed electronic newsletters to read that may help participant be more physically active.

Electronic Newsletters

Research staff provides telephone counseling to participant and partner biweekly during weeks 1-8 (weeks 1, 3, 5, and 7), and monthly during weeks 9-16 (weeks 11 and 15).

Telephone Counseling

Larkin L. Strong, PHD

The goal of this research study is to learn if enrolling in a program with a partner that involves monitoring each other's physical activity and providing support to one another can help both participants be more physically active.

Study Groups:

If you are found to be eligible to take part in this study, you and your partner will be randomly assigned (as in a flip of a coin) to be in 1 of 2 groups after you complete the first in-person visit. You will have an equal chance of being in any group.

If you are assigned to Group 1, the following tests and procedures will be performed:

* You will wear an activity tracker that you will be given at the baseline visit. The activity tracker is a small device worn on your wrist that records how many steps you have taken.
* You will be instructed in the use of a smartphone application at the baseline visit which you will use to track your physical activity, connect with your partner to share information about your physical activity, and provide support to your partner to be more physically active.
* You will have 6 counseling calls over the telephone throughout the study with a trained counselor and your partner.
* You will be emailed electronic newsletters to read that may help you be more physically active.

If you are assigned to Group 2, you will be sent the newsletters that may help you be more physically active and upon completing the16 week visit, you will be given an activity tracker and instruction in the use of a smartphone application.

Study Visits:

You will visit MD Anderson Cancer Center, Windsor Village United Methodist Church, or a community site 2 times (1 time at the beginning of the study, and 1 time 16 weeks after you begin the study). Each visit should take about 90 minutes. The following procedures will be performed:

* Your blood pressure will be measured. If you have a blood pressure reading higher than 140/90 mm Hg, you can participate in this study only with a clearance letter from your physician or nurse practitioner. If your blood pressure reading is higher than 180/120 mm Hg, the study staff must contact 911 and have EMS come and treat you due to your blood pressure being dangerously high. You have the right to refuse EMS services but study staff are still required to contact 911 immediately as a precaution. You will not be able to continue in the study until the clearance letter has been received.
* You will complete questionnaires about your feelings, moods, your motivation for physical activity, any social support you may receive from others, the neighborhood you live in, and other physical activity-related topics. The questionnaires should take about 45 minutes to complete. For the 2nd visit, you will have the option of completing the questionnaire online before your scheduled visit. This may reduce the length of your 2nd visit.
* You will be asked about your diet (for example, what you eat and drink each day).
* Your height, weight, and waist and hip circumference will be measured. To measure your waist and hip circumference, you may be asked to lift your shirt to expose your stomach area and lower your pants to expose your mid-hip area. The height, weight, and waist and hip circumference measurements should take about 10 minutes and will be performed in a private area.
* Your heart rate variability (HRV) will be measured with a wrist watch and a belt band. To measure your HRV, you will be asked to lift your shirt to expose your upper stomach area (at the breast bone). The band will be damp and should make firm contact with your skin. °You will wear the device for 5 minutes while it records your HRV as you sit quietly.
* You will be given an accelerometer at each visit. You will wear the accelerometer for 7 days and then return it in an pre-addressed envelope provided to you. An accelerometer is a small device that is worn on your hip that measures the amount of physical activity you do.

At 8 weeks after you begin the study, you will answer some questions either over the phone or through an online survey. The questions will cover the same topics as for the in-person visits. This should take about 30 minutes to complete.

All participants will be invited to take part in a final focus group. This focus group will take place sometime after the 16-week visit. You will be asked what you think about the study, including what you liked, did not like, and how you think it could be improved. If you want to provide this feedback but you cannot come to the focus group, you may provide feedback in another way (such as a phone interview or you could meet the study staff at the church or a community setting). These focus groups/interviews will be audio recorded. Your name and identifying information will be deleted from the recording before being transcribed (typed out) by an outside party. This should take about 90 minutes. The digital audio files will be destroyed within 10 years after publication.

Length of Study:

Your participation on this study will be over after you complete the final focus group visit.

Additional Information:

If you are assigned to Group 1, you may be contacted by phone or mail while you are taking part in this study to remind you about study visits, study procedures, and counseling calls.

You will be asked to give the names and contact information of family members and/or friends for the study staff to contact in the event they cannot reach you first.

The counseling calls for Group 1 will be recorded to monitor counseling procedures.

You will also be asked to participate in two optional procedures. First, you will be asked to "friend" your counselor on the mobile application so that the counselor can monitor your steps in preparation for the counseling calls. Second, you will also be asked to share your user ID and password for the activity tracker. This will enable research staff to download your physical activity data that will help staff to understand how much participants are using the device and how many steps they are taking. These data will only be examined during the 16-week study period, and you will be instructed to change your password at the end of the study.

If the accelerometer is lost or stolen, you will not be responsible for the replacement cost, but you should tell the study staff right away.

You will be able to keep the activity tracker after the study is complete.

Your home address may be used to access public information about the area where you live. This is to help researchers learn about how your neighborhood encourages physical activity. The results from this study will only be reported as a group and you will not be identifiable from any products resulting from this study (such as research papers). Your home address will never be released or published in any form. Your address will be stored separately from other study data, and only the study chair will be able to see the data after the neighborhood information has been collected.

You may be contacted in the future to see if you would agree to take part in other research studies.

Women who are pregnant or thinking about becoming pregnant during the study period will no longer be able to participate. If you become pregnant during this study, please tell the study staff right away.

This is an investigational study.

Up to 64 participants will take part in this study. All will be enrolled at MD Anderson.

Using Social Networks to Promote Physical Activity in African American and Hispanic Women

Women's preferences for a physical activity (PA) promotion intervention determined by focus groups.

Study considered feasible only if recruitment and retention percentages reach the lower bound of the one-sided 90% confidence intervals of the target unless there are convincing arguments they can be improved sufficiently by modifying recruitment or retention strategies.

Gastrointestinal Neoplasms

Digestive System Neoplasms

Comparison group. Regular colonoscopy preparation

APP as additional device for colonoscopy preparation

additional usage of an app for colonoscopy preparation

APP supported colonoscopy preparation

Benjamin M Walter, MD

Benjamin Walter, MD

von Delius Stefan, MD

Katharina Strehle

Peter Klare, MD

Neu Bruno, MD

Feasibility of an newly programmed offline application for smartphones (SPA, APP) for colonoscopy preparation offering a 5 day guidance prior colonoscopy containing dietary- and behavioral recommendation.

First feasibility testing of a newly programmed app/SPA for android system named Colopr-APP. It is an strictly offline working, autonomous system downloaded to the smartphone. It creates an 5-day guidance prior outpatient colonoscopy with dietary and behavior recommendations.

Improvement of Colonoscopy Preparation by New Media (APP)

First Experiences With an Offline App (SPA; Smartphone Application) for Colonoscopy Preparation- PERICLES-I APP; Prospective Evaluations of Improvement of Colonocopy Preparation by Optimized Visualization (PERICLES)

feasibility of app supported colonoscopy preparation (stable working and function of software on smartphone)

Evaluation of bowel preparation during colonoscopy by BostenBowelPreparation Scale

Evaluation of patient´s satisfication by a questionaire

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Smartphone Pain App for Assessing Oral Mucositis Pain in Patients	NCT02727062	Oral Mucositis	OM Pain App Accelerometer	18 Years -	Medical College of Wisconsin
Smartphone Pain App for Assessing Oral Mucositis Pain in Patients	NCT02727062	Oral Mucositis	OM Pain App Accelerometer	18 Years -	Medical College of Wisconsin
Mobility and Physical Activity in Adolescent and Young Adult Cancer Patients or Survivors at Risk for Cardiovascular Morbidity and Frailty, The MOBILE AYA Study	NCT05169151	Central Nervous... Hodgkin Lymphom... Malignant Solid... Non-Hodgkin Lym... Sarcoma	Smartphone Appl...	15 Years - 39 Years	M.D. Anderson Cancer Center
Using Social Networks to Promote Physical Activity in African American and Hispanic Women	NCT03199196	Cancer Preventi...	Activity Tracke... Smartphone Appl... Questionnaires Focus Group Electronic News... Telephone Couns...	25 Years - 60 Years	M.D. Anderson Cancer Center
Improvement of Colonoscopy Preparation by New Media (APP)	NCT02512328	Gastrointestina...	APP supported c...	18 Years -	Technical University of Munich
Improvement of Colonoscopy Preparation by New Media (APP)	NCT02512328	Gastrointestina...	APP supported c...	18 Years -	Technical University of Munich

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