Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Behaviors and Mental Disorders

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Quality of Life

All Drugs and Chemicals

Hormones

After completion of chemotherapy and/or radiation, 3-6 weeks after surgery, and then 3-7 months after surgery: Participants complete 4 questionnaires about physical abilities, motivation, and quality of life. Participant's hand grip strength measured. Participants arm strength measured using an arm curl test. Participants asked to rise from a chair without using their arms to push off. Participants complete a 6-minute walk test to see how far participant can walk in 6 minutes. Participants complete a nutritional questionnaire and receive nutritional counseling. Participants receive educational materials and personalized counseling based on participant's answers.

Participants encouraged to remain active during chemotherapy and/or radiation. Participants receive a booklet that contains a stretching guide with full-body stretches and safety.

After completion of chemotherapy and/or radiation, 3-6 weeks after surgery, then 3-7 months after surgery: Participants complete 4 questionnaires about physical abilities, motivation, and quality of life. Participant's hand grip strength measured. Participants arm strength measured. Participants asked to rise from a chair without using their arms to push off. Participants complete a 6-minute walk test to see how far participant can walk in 6 minutes. Participants complete a nutritional questionnaire and receive nutritional counseling. Participants receive educational materials and personalized counseling based on participant's answers.

Participants complete moderate-intensity aerobic exercise 5 days each week. Participants complete strength training exercises 2 times per week.

Participants contacted by phone by member of study staff 1 time each week for the first 4 weeks, and then every 2 weeks after that for behavioral skills training and to see how participant is doing.

Participants complete 4 questionnaires about physical abilities, motivation, and quality of life They should take about 25 minutes total to complete.

Questionnaires

Participants complete a nutritional questionnaire and receive nutritional counseling. It should take about 5 minutes to complete. Participants receive educational materials and personalized counseling based on participant's answers.

Nutritional Questionnaire and Nutritional Counseling

Participants receive a booklet that contains a stretching guide with full-body stretches and safety.

Booklet

Participants complete up to 30 minutes of moderate-intensity aerobic exercise (such as brisk walking, stationary cycling, and/or elliptical or stair stepping machines) for at least 5 days each week. Participants complete strength training exercises at least 2 times per week.

Aerobic Exercise and Strength Training Exercises

Participants contacted by phone by member of study staff one (1) time each week for the first 4 weeks, and then every 2 weeks after that for behavioral skills training and to see how participant is doing. These calls should last about 15 minutes.

Phone Calls

After completion of chemotherapy and/or radiation, 3-6 weeks after surgery, and then 3-7 months after surgery: Participant's hand grip strength measured using a hand-held machine. Participants arm strength measured using an arm curl test. Participants asked to rise from a chair without using their arms to push off. Participants complete a 6-minute walk test to see how far participant can walk in 6 minutes.

Physical Assessments

Matthew H. Katz, MD

Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant.

The goal of this clinical research study is to learn if regular exercise and behavioral skills training can help to improve physical activity in patients with pancreatic cancer who are scheduled to receive chemotherapy and/or radiation before standard-of-care surgery.

This is an investigational study.

Up to 128 participants will be enrolled on this study. All will take part at MD Anderson.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study arms. This is done because no one knows if one study arm is better than, the same, or worse than the other group.

If you are in Arm A, you will not take part in a structured exercise program. If you are in Arm B, you will take part in a structured exercise program and behavioral skills training as described below.

Length of Study:

You will continue to take part in this study for up to 7 months after your scheduled standard-of-care surgery. However, if intolerable side effects occur or the disease appears to get worse, the study staff will decide if continuing the exercise program is in your best interest.

Study Visits:

At your baseline visit, after you complete chemotherapy and/or radiation, 3-6 weeks after surgery, and then 3-7 months after surgery:

* You will complete 4 questionnaires about your physical abilities, motivation, and quality of life. They should take about 25 minutes total to complete.
* Your hand grip strength will be measured using a hand-held machine
* Your arm strength will be measured using an arm curl test. You will be given a small weight (about 5-8 pounds) and asked to perform as many bicep curls as you can for 30 seconds.
* You will be asked to rise from a chair without using your arms to push off.
* You will complete a 6-minute walk test to see how far you can walk in 6 minutes.
* You will complete a nutritional questionnaire and receive nutritional counseling. The questionnaire will ask about your diet and any recent weight loss. It should take about 5 minutes to complete. After you complete the questionnaire, you will receive educational materials and personalized counseling based on your answers.
* If you are in Arm B, you will receive behavioral skills training to teach you ways to monitor your health, set goals, and reward yourself. It should take about 15 minutes to complete.
* At the baseline visit, you will be given a Fitbit Charge 2 activity tracker to wear during the study. This is a small device designed to record your physical activity and sleep during the study. This device will allow you to monitor your own physical activity and sleep and may help you achieve your goals. You can keep the Fitbit after the study is over.

If you are in Arm B, one (1) time each week for the first 4 weeks and then every 2 weeks after that, a member of the study staff will contact you by phone for behavioral skills training and to see how you are doing. These calls should last about 15 minutes.

For 2 weeks during each phase of chemotherapy and/or radiation you receive, you will wear a small activity monitor on an elastic band. This will be worn in addition to your Fitbit.

Exercise Programs:

ARM A:

If you are in Arm A, you will be encouraged to remain active during chemotherapy and/or radiation, but you will not receive instruction about aerobic or strengthening exercises. You will receive a booklet that contains a stretching guide with full-body stretches and safety.

ARM B:

If you are in Arm B, you will be asked to complete up to 30 minutes of moderate-intensity aerobic exercise (such as brisk walking, stationary cycling, and/or elliptical or stair stepping machines) for at least 5 days each week.

You will also complete strength training exercises at least 2 times per week. You will complete 1 set of 10-15 repetitions for each of the 8 exercises that you are taught. Over time, the amount of resistance, repetitions, and/or sets may increase or decrease based on your strength. You will be given 5 different resistance tubes to complete these exercises, but you may use free-weights or machines if you prefer.

You should complete warm up exercises and 5 minutes of stretching before and after strength training.

You must keep a daily activity log to document your exercises.

PancFit: Multimodal Exercise During Preoperative Therapy for Pancreatic Cancer

PancFit: Multimodal Exercise During Preoperative Therapy for Pancreatic Cancer: A Randomized Trial Testing Effects on Fitness, Health-Related Quality of Life, and Tumor Vasculature

Primary endpoint is the change in 6MWT distance, measured in meters, between the time at which preoperative therapy is administered (T0) and the time at which it ends (T1).

M.D. Anderson Cancer Center

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Participants read the booklet about colorectal cancer screening tests, and listen to an audio CD that will narrate the booklet. Questionnaire completion before and after viewing the program.

Participants watch a video with non-moving images about colorectal cancer screening tests on an iPad. Questionnaire completion before and after viewing the program.

Participants watch a video with animated images about colorectal cancer screening tests on an iPad. Questionnaire completion before and after viewing the program.

Participants read a booklet about colorectal cancer screening tests.

Participants listen to an audio CD that will narrate the colorectal cancer screening tests booklet.

Audio CD

Participants watch a video with non-moving images about colorectal cancer screening tests on an iPad.

Video with Non-Moving Images

Participants watch a video with animated images about colorectal cancer screening tests on an iPad.

Video with Animated Images

Questionnaire completion before and after viewing the program.

Robert Volk, PHD

The goal of this research study is to compare how people who are 45-75 years old respond to 3 different versions of a program about screening tests for colorectal cancer. Researchers want to use this study as part of a long-term project to learn the best ways to communicate health information to patients.

If you agree to take part in this study, you will be randomly assigned (as in a roll of dice) to 1 of 3 study groups. Neither you nor the study staff will be able to choose which group you will be in:

* If you are in Group 1, you will read a booklet about colorectal cancer screening tests. While reading the booklet, you will also listen to an audio CD that will narrate the booklet.
* If you are in Group 2, you will watch a video with non-moving images about colorectal cancer screening tests on an iPad.
* If you are in Group 3, you will watch a video with animated images about colorectal cancer screening tests on an iPad.

You will complete questionnaires before and after viewing the program that will contain questions about:

* Your age and what language you speak
* Your math and reading comprehension
* Your knowledge of colorectal cancer and colorectal cancer screening
* Your thoughts about colorectal cancer screening
* Your opinions about this study, and
* How well you understand the booklet/video you view as part of this study

It will take about 1 hour to complete all the questionnaires. In total, the study will take about 1 ½ to 2 hours to complete. After you have completed the questionnaires, your participation in the study will be over.

This is an investigational study.

Up to 201 people will take part in this multicenter study. Up to 67 will be enrolled at MD Anderson.

Using Multimedia Approaches to Communicate Probabilities in Patient Decision Aids for Low-Literacy Populations: Randomized Trial

The fixed effects analysis of variance (ANOVA) will utilize a factorial design with two factors: content presentation type (standard, animated, interactive) and numeracy status (high and low based on US population scores). Main dependent measures are gist and verbatim knowledge. Gist and verbatim knowledge scores (0-100) looked at separately as well as combined.

Foundation for Informed Medical Decision Making

Adenocarcinoma

Series of physical and quality of life assessments administered to participants, taking about 20 minutes to complete. Participants instructed to perform resistance/strengthening exercises for 30 minutes two times each week. Exercise instructional booklet given to all participants describing all exercises. Participants to walk 20-30 minutes at least 3 times a week. Nutrition program discussed with participants. Participants receive phone calls from study staff every 2 weeks for 6 weeks to check for adherence, and if they are having any side effects from the exercise.

Series of physical and quality of life assessments administered to participants, taking about 20 minutes to complete.

Participants instructed to perform resistance/strengthening exercises for 30 minutes two times each week. Participants to walk 20-30 minutes at least 3 times a week. Participants issued a set of 3 resistance exercise bands with which the exercises can be performed.

Exercise

Within 7 days after being enrolled on study, participant meets with a dietitian to discuss nutrition.

Nutrition Counseling

Participants receive phone calls from study staff every 2 weeks for 6 weeks to check for adherence, and if they are having any side effects from the exercise.

Exercise instructional booklet given to all participants describing all exercises.

The goal of this research study is to learn if it is possible to start a home-based exercise and nutrition program for patients with pancreatic cancer or who may have pancreatic cancer before surgery (pre-operative rehabilitation, also known as prehabilitation).

Study Procedures:

If you are found to be eligible to take part in this study, you will be asked to complete additional questionnaires about your physical activity and quality of life. It will take about 20 minutes to complete all of the questionnaires in this study. Your strength and walking speed will also be checked using a hand-held grip test, having you stand from a sitting position five times, and a 6 minute walking test.

The exercise regimen will then be discussed with you. It will include a resistance/ strengthening program and a walking program.

You will receive a booklet and an instructional video describing all of the exercises, a set of resistance tubes and accessories you need to perform all exercises, and a pedometer to count your daily steps. Also, a specialist in rehabilitation along with other study staff will teach you the stretching and strengthening exercises. An MD Anderson rehabilitation doctor will oversee all of this.

Resistance/Strengthening Program:

You will be instructed to perform resistance/strengthening exercises for 30 minutes at least two times each week.

The exercises used in this study are designed to strengthen your muscles. Strengthening certain muscle groups will help with upper body control and balance, which the study staff believes may help with mobility before and after surgery. Also, strengthening the shoulder, back, and leg muscles are important for activities such as getting into and out of bed, which is important after surgeries such as pancreas surgery.

You will be instructed to perform any 8 (out of 19) strengthening exercises for a total of 30 minutes. You will be issued a set of 3 resistance exercise tubes with which the exercises can be performed. The strengthening exercises consist of seated and standing weight-bearing exercises. You will perform 3 sets of 8-12 repetitions each of each exercise. When you are able to perform 3 sets of 12 repetitions of an exercise, you will move up to the next level of resistance (different color tube).

Before the strengthening exercises, you will do a series of 4 standing warm-up exercises that will help with balance.

You will record the date, resistance (color of resistance tube used), number of repetitions and sets, and how hard a session of resistance exercises felt for you. You will also record the total time spent on the strengthening program after each exercise session

You will be encouraged to complete an additional 5 minutes of stretching following the exercises. You will be provided with a handout demonstrating upper body, back, and leg stretches to help prevent soreness.

Walking Program:

The walking program will consist of walking briskly for 20-30 minutes at least 3 times each week. If you are unable to tolerate walking at a brisk speed, you will be instructed to walk at a slower pace. You will be given a pedometer and will be instructed to record the number of steps taken each day in addition to the total time spent during each walking session.

Nutrition:

Within 7 days after being enrolled on this study, you will meet with a dietitian to discuss your nutrition. You will be then be provided with recommendations for calorie, protein, and fluid intake, tools for tracking intake (such as a diet log), as well as goals for weight depending on your treatment/recovery. You will also be instructed to eat a high protein snack/meal/shake within 1 hour after each strengthening session.

Phone Calls:

You will be called every 2 weeks and asked if you are following the exercise and nutrition programs and if you are having any side effects from the exercise (such as pain or difficulty breathing). You will also be asked which resistance band you are using. Each phone call will take about 10-15 minutes.

Length of Study:

You will use the exercise programs during your entire pre-operative period, including during the time you are on other treatments before surgery. In addition, you will continue the exercise program and evaluations for up to 4 months after you have had surgery. If you have a side effect or the disease gets worse, the study staff will decide if continuing the exercise program is in your best interest.

This is an investigational study.

Up to 70 participants will be enrolled on this study. All will take part at MD Anderson.

Preoperative Rehabilitation During Neoadjuvant Therapy for Pancreatic Cancer

Preoperative Rehabilitation During Neoadjuvant Therapy for Pancreatic Cancer: A Pilot Study

Feasibility established if \> 60% of patients are adherent. Prehabilitation program deemed feasible if 60% or more of participants complete at least 60% of the weekly 150-minute combined walking and strengthening exercises during the 6-week preoperative period.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PancFit: Multimodal Exercise During Preoperative Therapy for Pancreatic Cancer	NCT03187951	Other Disorders... Pancreatic Canc...	Questionnaires Nutritional Que... Booklet Aerobic Exercis... Phone Calls Physical Assess...	18 Years -	M.D. Anderson Cancer Center
Using Multimedia Approaches to Communicate Probabilities in Patient Decision Aids for Low-Literacy Populations: Randomized Trial	NCT02151032	Colorectal Canc...	Booklet Audio CD Video with Non-... Video with Anim... Questionnaires	45 Years - 75 Years	M.D. Anderson Cancer Center
Preoperative Rehabilitation During Neoadjuvant Therapy for Pancreatic Cancer	NCT02295956	Pancreatic Canc...	Questionnaires Exercise Nutrition Couns... Phone Calls Booklet	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for booklet

Every month we try and update this database with for booklet cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for booklet

Every month we try and update this database with for booklet cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for booklet cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.