Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Physical activity

This 2-part study will examine how much exercise people usually do in the course of their daily lives and how two different types of exercise-stretching and walking-affect the amount of fat in the body and certain hormones in the blood. It will also examine whether exercise can be increased by physician counseling with and without the use of a pedometer, and if exercising changes levels of stress, anxiety, and depression.

Breast cancer survivors and women at high risk for breast cancer who are between 18 and 75 years of age and who exercise less than 3 times per week may be eligible for this study. Candidates are screened with a medical history and physical examination, and their endurance and flexibility are tested by stretching exercises and by a 6-minute walk or run.

All participants complete study Part 1. Those who are eligible may also participate in Part 2.

* Part 1: Subjects wear a pedometer (a small device that measures the number of steps taken) on their waistband during all waking hours for 1 week without changing their usual level of activity. Depending on their level of activity, subjects may be invited to participate in Part 2 of the study.
* Part 2: Subjects are placed in either a walking group or a stretching group for 12 weeks. At the end of the 12-week period, those in the walking group are offered participation in the stretching group, and those in the stretching group are offered participation in the walking group.

Walking group participants wear a pedometer every day for 12 weeks. They are asked to gradually increase the number of steps they take each day, to keep a record of their daily step count, and to report periodically to the study staff on their progress. For 1 week during the study, participants also wear a device called an accelerometer that is used to verify the accuracy of the pedometer step counts.

Stretching group participants follow a program of stretching exercises for 12 weeks, with their progress monitored periodically by staff. During week 12, participants wear a pedometer and accelerometer.

All Part 2 participants also have the following tests and procedures:

* Blood draw: collected at the beginning and end of the study to test for certain hormones and HDL cholesterol levels.
* Questionnaires: about stress, anxiety, and depression levels; these are completed at the beginning and end of the study, and a detailed questionnaire about diet is completed at home or during a clinic visit.
* Body composition measurement: A "bioelectrical impedance" test, which measures body fat, is done at the beginning and end of the study. For this test, the subject lies on an examining table and a small electrical current is passed through electrodes placed on one hand and one foot. Although a small electrical current is used, this test is not painful.
* Endurance and flexibility testing: At the end of the study, participants repeat the 6-minute walk or run endurance test and the stretching flexibility test performed at screening.

Background:

Evidence suggests that high levels of physical activity can decrease breast cancer risk.

Physical activity could therefore represent a viable breast cancer prevention strategy.

In order to study the effect of physical activity on breast cancer risk, we must first develop feasible and efficacious physical activity interventions.

Objectives:

Primary:

To determine the rate of compliance with a physical activity intervention using a pedometer, a physician prescription, and a motivational booklet.

To determine whether this intervention is more effective than a control of stretching exercises at increasing physical activity.

Secondary:

To determine whether physical activity as measured by a pedometer correlates with other measures of physical activity.

To assess the effect of the physical activity intervention on serum biomarkers, quality of life, functional capacity and body composition.

To examine long-term compliance with a program of increased physical activity and assess post program exercise motivation and adherence.

Eligibility:

Eligible patients are women age 18-75 who meet one of the following criteria:

History of breast cancer without evidence of recurrent disease.

Gail model 5 year risk greater than 1.7%.

Claus model lifetime risk greater than 20%.

History of appropriately treated DCIS.

History of high risk lesion on breast biopsy (ADH, ALH, LCIS).

Known or suspected BRCA1 or BRCA2 mutation.

Patients must be sedentary at baseline and must be medically fit to exercise.

Design:

This is a randomized pilot study designed to assess the feasibility of a physical activity intervention in breast cancer survivors and women at high risk for breast cancer.

Stage I: Patients undergo a baseline activity evaluation for one week which involves wearing a sealed pedometer - those that have an average daily step count of less than 5,000 steps are eligible for randomization.

Stage II: Patients are assigned to either a walking intervention, (including a pedometer, a physician exercise prescription with a final goal of walking 10,000 steps per day, and a motivational booklet) or a control of stretching exercise for a period of 12 weeks.

Biomarkers, functional capacity, body composition and diet are assessed at the beginning and end of study.

This study plans to randomize 80 subjects, and has a greater than 90% power to detect a mean increase of 3,000 steps per day in intervention subjects.

Exercise in Women at Risk for Breast Cancer

A Pilot Study of a Three Month Intervention for Increasing Physical Activity in Sedentary Women at Risk for Breast Cancer

National Cancer Institute (NCI)

Giuseppe Giaccone, M.D./National Cancer Institute

Participants will wear a pedometer for 4 days at baseline, and 4-6 weeks later. Baseline readings will be used to derive an individualized exercise program for each participant based on the assigned experimental arm.

Pedometer

Participants will wear a Actigraph for 4 days at baseline and 4-6 weeks later. Baseline readings will be used to derive an individualized exercise program for each participant based on the assigned experimental arm.

Actigraph

Participants will walk on an instrumented treadmill while wearing a safety harness at baseline and 4-6 weeks later. The perturbation treadmill will assess an individual's risk for falling. Baseline readings will be used to derive an individualized exercise program for each participant based on the assigned experimental arm.

Perturbation Treadmill

Christine Huyber

Kathie Bernhardt

Christine Huyber, BS

Aminah Jatoi, M.D.

Falls are common and catastrophic in cancer patients. Cancer patients are vulnerable to falls due to muscle loss. In prescribing exercise in a data driven manner to cancer patients, our hypothesis is this "prescription" for exercise will eventually be demonstrated to reduce the occurrence of injurious falls.

The investigator will incrementally increase the exercise prescription for groups of patients.

"Prescribing" Exercise to Cancer Patients at High-Risk for Falls

Patient Reported Outcome 0% No confidence, 100% Complete Confidence, higher score= better outcome

Andersen Foundation

Mayo Clinic

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Androgens

Dr Alain Maillette, urologist

Dr Alain Maillette, Urologist

A randomized clinical trial evaluating the use of a pedometer and brief exercise coaching in prostate cancer patients treated with androgen deprivation therapy. The investigators want to demonstrate if there are less side effects of hormonal therapy and better quality of life in patients who made regular exercise.

To evaluate effectiveness of regular exercise and well-being all patients will complete questionnaires about sexual function (IIEF-15) and quality of life. We will also perform at each visits anthropometrics measurement of waist, leg and arm, weight and vital signs. Biochemical analysis and prostatic specific antigen will be done periodically.

Pedometer and Exercise Study in Prostate Cancer Patients With Hormonal Therapy

Pedometer and Exercise Study: A Randomized Trial Evaluating the Use of a Pedometer and Brief Exercise Coaching in Prostate Cancer Patients Treated With Androgen Deprivation Therapy.

Groupe de recherche en Urologie de la Mauricie

Dr Alain Maillette

Digestive System Diseases

Gland and Hormone Related Diseases

Symptoms and General Pathology

Rare Diseases

Pancreatic Neoplasms

Neoplasm Metastasis

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Gastrointestinal Agents

Pancrelipase

Pancreatin

Questionnaires + Blood Draw + Pedometer used to learn about symptoms related to chemotherapy and the disease, in patients with advanced pancreatic cancer.

Questionnaires including symptom review (MDSAI-GI) via personal or telephone interviews (interactive voice response telephone system - IVRS)

Questionnaires

Blood sample (3½ tbs.)to measure levels of cytokines (biomarkers in the blood) and DNA (the genetic material in cells) before treatment starts.

Blood Draws

Xin Shelley Wang, MD, MPH

The goal of this clinical research study is to learn about symptoms related to chemotherapy and the disease, in patients with advanced pancreatic cancer. Researchers will study the possible reason for these symptoms by drawing blood samples and comparing the test results to the symptoms you experience. The study will also use a special telephone system for measuring the symptoms of participants during and after therapy. Your level of physical activity will also be studied using a pedometer and study diary.

Researchers want to try to improve patient care for advanced pancreatic cancer by looking at how some symptoms create a great burden on daily life. They also want to find out which "markers" in the blood. Biomarkers are substances found in the blood, such as cytokines, certain proteins, and DNA changes. These biomarkers may help doctors predict "symptom burden" during therapy.

Researchers would also like to collect data about your physical function as part of this study. If you agree to wear a pedometer, you will wear the pedometer every day for a month during your waking hours. The pedometer used in the study is a small box that weighs less than an ounce and is smaller than a deck of playing cards. It is used to measure the number of steps you take during the day. Researchers will help you set the pedometer and show you how to use it. You will also keep a diary to record your use of the pedometer during this month. Researchers will meet with you during your clinic visits for chemotherapy at 2 weeks and 4 weeks to collect the data.

If you agree to take part in this study, you will have the following 4 types of study procedures performed:

Questionnaire:

Before chemotherapy that is scheduled by GI Medical Oncology Clinic starts, you will be asked to complete a questionnaire during a visit to the clinic. The questionnaire will measures physical and emotional symptoms. It should take about 5 minutes to finish. During this visit, the research staff will also teach you how to use the telephone system for measuring symptoms. You will tell the research staff the most convenient times for the telephone calls each week and the system will be set up to call you at that time.

Blood Draws:

Before you begin your chemotherapy treatments, you will have a sample of blood drawn (around 3½ tablespoons). The sample of blood will be used to measure levels of cytokines (biomarkers in the blood) and DNA (the genetic material in cells) in your blood before treatment starts. These cytokines may be related to symptoms experienced while having treatment for cancer.

You will have about 2½ tablespoons of blood drawn again when you complete first and second cycle of chemotherapy, and then at 2 months and 4 months after the start date of chemotherapy. Each blood sample will be drawn during your routine blood draw for continuing chemotherapy.

Symptoms Review:

You will have a MDASI-GI symptom assessment face to face, by regular mail, or through the phone calls. These will be used to measure symptom burden over time of the treatment and after treatment. The assessments will be done weekly for up to 4 months and then twice a month for up to an additional 14 months.

If your assessment is done by phone, it may be done by a study staff member or by using an interactive voice response telephone system (IVRS). During the study, the automated telephone system will call you once a week to ask you to rate your symptoms and how much the symptoms get in the way of your daily life. The information collected by these calls is only being used for this research study. This phone call should take about 5 minutes to complete.

This is an investigational study. Up to 100 patients will take part in this study. All will be enrolled at MD Anderson.

Blood drawn (around 3½ tablespoons) before treatment starts to measure cytokines (biomarkers) and DNA.

Identifying the Role of Symptom Outcomes and Biomarkers in Survival in Patients With Metastatic Pancreatic Cancer

A Feasibility Study for Identifying the Role of Symptom Outcomes and Biomarkers in Survival in Patients With Metastatic Pancreatic Cancer

M.D. Anderson Cancer Center

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Patients wear a pedometer for step count monitoring over 6 weeks.

Patients wear a FitBit for step count monitoring over 6 weeks.

FitBit

Quality-of-Life Assessment

Questionnaire Administration

Shiao-Pei S Weathers

Shiao-Pei S. Weathers

This trial studies the feasibility of monitoring step count as a measure of physical activity in patients with newly diagnosed glioma undergoing radiation therapy. Physical activity measured by step count may help to improve the quality of life and symptoms for patients with newly diagnosed glioma.

PRIMARY OBJECTIVE:

I. Evaluate the feasibility of monitoring step count as a measure of physical activity in patients with newly diagnosed glioma undergoing radiation therapy (RT) at MD Anderson Cancer Center (MDACC).

SECONDARY OBJECTIVE:

I. Estimate the effects of physical activity as measured by step count on cognition, fatigue, anxiety and depression scores and assess differences between groups.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients wear a pedometer for step count monitoring over 6 weeks.

GROUP II: Patients wear a FitBit for step count monitoring over 6 weeks.

After completion of study, patients are followed up at 3 and 6 months after completing radiation therapy.

Step Count Monitoring as a Measure of Physical Activity in Patients With Newly Diagnosed Glioma Undergoing Radiation Therapy

Feasibility of Monitoring Step Count as a Measure of Physical Activity in Patients With Newly Diagnosed Glioma Patients Undergoing Radiation Therapy

Feasibility will be assessed by the consent rate. Will calculate the rates, frequencies, and 90% confidence intervals (CIs) of the proportions by group and in total, as well as for the differences between intervention groups, as applicable.

Feasibility will be assessed by treatment group (Fitbit) adherence rate. Intervention adherence is defined as wearing the Fitbit for a total of at least 340 hours across the 6-week intervention period. Will calculate the rates, frequencies, and 90% CIs of the proportions by group and in total, as well as for the differences between intervention groups, as applicable.

Feasibility will be assessed by the retention rate. Retention will be defined by the completion of assessments, by the end of the intervention (6 weeks from baseline) in each group. Will calculate the rates, frequencies, and 90% CIs of the proportions by group and in total, as well as for the differences between intervention groups, as applicable.

Will evaluate the satisfaction/acceptability rate in both FitBit and pedometer groups. Will calculate the rates, frequencies, and 90% CIs of the proportions by group and in total, as well as for the differences between intervention groups, as applicable.

Mobility Limitation

Analgesics

Central Nervous System Depressants

Narcotics

This group will be given a pedometer following radical prostatectomy. Subjects in the experimental group will have a graduated step-count goal as follows: POD 0-2: 2,000/day. POD 3-6: 3,000/day. POD 7-9: 4,000/day. POD 10-14: 5,000/day.

This is the control group. Following radical prostatectomy, subjects in the control group will receive standard of care, which includes counseling regarding the importance of ambulation following surgery.

Subjects in the study group will receive a pedometer with graduated step count goals as discussed in arm description.

Use of a pedometer following surgery

Subjects in the control group will be counseled on the importance of ambulation during their pre-operative visit.

Standard of care

Basil Ferenczi, MD

John Corman, MD

This is a study to evaluate whether use of a pedometer following radical prostatectomy decreases post-operative narcotic use and time to return of bowel function.

This is a randomized controlled prospective study looking at the effect of using a pedometer with graduated step-count goals following radical prostatectomy on return of bowel function and post-operative narcotic use. Subjects will be randomized into a control group or study group. The control group will receive standard of care, with information provided regarding the importance of ambulation following surgery. The study group will receive a pedometer with graduated step-count goals from post-operative day 0 to post-operative day 14. Both groups will be given a standardized post-operative narcotic regimen, and will be asked to record initial passage of flatus and first bowel movement. Subjects will remain on the study until initial post-operative visit.

Use of Pedometer Following Radical Prostatectomy

Does the Use of a Post-Operative Pedometer Affect Rate of Return of Bowel Function and Narcotic Use Following Laparoscopic Robot Assisted Radical Prostatectomy

Morphine equivalents used following radical prostatectomy.

First passage of flatus and first bowel movement following surgery

Virginia Mason Hospital/Medical Center

Benaroya Research Institute

Behaviors and Mental Disorders

Carcinoma

Quality of Life

At baseline study visit, participant shown how to complete the physical exercises performed while on study. Pedometer received to track physical activity. Resistance training bands given to use as part of the home-based exercise program. At the baseline study visit, directions received on how to use the study website. Access given to website that will allow tracking of exercise behavior and help set goals. Access given to an internet-based curriculum that will help teach about goal-setting, overcoming barriers to physical activity, self-management strategies, and time-management skills. Participant asked to visit website every week. Participant records activity and the number of steps taken every day on the website. Survey completed monthly about attitudes and beliefs about physical activity.

Access given to internet-based curriculum to help teach about goal-setting, overcoming barriers to physical activity, self-management strategies, and time-management skills. Participants read information about improving the quality of their diet and cutting back on sedentary behavior. Participants record on the website how much television watched and how many fruits and vegetables eaten every day. Survey completed monthly about attitudes and beliefs about sedentary behavior and dietary intake.

Patients participate in chair-based exercise study. Participants receive chair-based exercise DVD. Chair-based exercise program participation for a total of 8 weeks. Participants receive self-report assessments about quality of life and asked to participate in physical assessments of their balance and coordination.

Resistance training bands, guidebook, and pedometer given at baseline visit. Internet-based curriculum access given to teach goal-setting, overcoming barriers to physical activity, self-management strategies, and time-management skills. Access given website that will allow participant to track exercise behavior and help set goals.

Exercise Program

Website access given that allows participant to track exercise behavior and help to set goals.

Website

Participants receive chair-based exercise DVD. Participants in this chair-based exercise program for a total of 8 weeks.

Exercise DVD

Exercise Intervention Program Group : Survey completion monthly about attitudes and beliefs about physical activity.

Sedentary Behavior and Dietary Intervention Group: Survey completion monthly attitudes and beliefs about sedentary behavior and dietary intake.

Survey

Self-report assessments given about quality of life and physical assessments of balance and coordination.

Self-Report Assessments

Richard A. Hajek, PHD, MS, BA

The goal of this behavioral research study is to find out more about the health behaviors of cancer survivors. Researchers want to understand the cultural, social, and environmental factors related to physical activity and personal diet. Researchers also want to learn if cancer survivors who take part in lifestyle interventions have better overall health and quality of life than those who do not take part in these interventions.

If you agree to take part in this study, you will have a baseline study visit. This visit will include a physical exam, including measurements of your height and weight. Your hips, wrist, mid-arm, and waist will also be measured. You will also fill out questionnaires that contain items about your diet and exercise habits as well as questions about your quality of life.

Study Groups:

You will be randomly assigned (as in the flip of a coin) to 1 of 2 groups.

* Group 1 will take part in an exercise intervention program.
* Group 2 will take part in a sedentary behavior and dietary intervention group.

Group 1--Exercise Intervention:

At the baseline study visit, the study staff will show you how to complete the physical exercises you will perform while you are on study.

You will receive a pedometer that you can wear on your waistband to track your physical activity. The pedometer is the size of a deck of cards and will be worn throughout the study to track your progress.

You will be given resistance training bands to use as part of the home-based exercise program. At the baseline study visit, you will receive a directions on how to use the study website. In addition, the study coordinator will walk you through each of these exercises. After the study is complete, you will be allowed to keep the resistance training bands and pedometer.

Participants in Groups 1 will receive access to a website that will allow you to track your exercise behavior and help you set goals. This data will be recorded for you, and your progress will be graphed throughout the course of the study.

You will be given access to an internet-based curriculum that will help teach you about goal-setting, overcoming barriers to physical activity, self-management strategies, and time-management skills. You are being asked to visit the website every week to read that week's lesson materials and to set weekly goals. In addition to this weekly visits, you will need to record your activity and the number of steps you take every day on the website. Each month, you will be asked to fill our a survey about your attitudes and beliefs about physical activity.

Group 2--Parallel-Study Group:

Participants who are assigned to this group will received access to the same website as Group 1. You will also be asked to read information about improving the quality of your diet and cutting back on sedentary behavior ( for example, television viewing and overall sitting). The website will allow you to track your sitting and dietary behaviors and help you set goals. This data will be recorded for you, and your progress will be graphed throughout the course of the study.

Participants in Group 2 will be given access to curriculum that will help teach you about goal-setting, overcoming barriers to improving your diet and cutting back on sedentary behavior, as well as learn self-management strategies and time-management skills. You are being asked to visit the website once a week to read that week's lesson materials and to set weekly goals. In addition to this weekly visit, you will need to record on the website how much television you watch and how many fruits and vegetables you eat every day. Each month, you will be asked to fill our a survey about your attitude and beliefs about sedentary behavior and dietary intake.

6-Month Follow-up Visit: For both groups (Groups 1 \& 2), at the 6-month follow-up visit, your weight and waist, hip, and arm measurements will be recorded and compared to your measurements from the baseline visit.

Length of Study:

For both groups, you will be taken off study if you experience side effects from taking part in the intervention, you are hospitalized for any reason, or you are diagnosed with a condition that needs a treatment not allowed while on this study.

Your participation on the study will be over once you have completed the 6-month visit.

This is an investigational study.

Up to 200 cancer survivors will take part in this study. Up to 150 will be enrolled at MD Anderson.

Lifestyle Intervention for High Risk Cancer Survivors

Development of an Aerobic and Resistance Training Feasibility Study for a Racially and Ethnically Diverse Sample of Breast Cancer Survivors

Data collected from mail-based surveys (n = 1,000) to assess intervention preferences, physical activity (PA), health related quality of life (HRQOL), and mediators of change (e.g., self-efficacy).

Rates of recruitment (% recruited out of the total number invited), retention (% completing the 6-month intervention), adherence (% completing 100% of study requirements), satisfaction, adverse events, and barriers to a home-based aerobic and resistance-training program.

Fatigue

Neoplasms, Second Primary

Patients in the GAR group will receive several recommendations and will have access to an online tool to increase motivation to engage in physical activity.

Patients will be equipped with pedometers for 8 weeks, all day and must complete the number of steps each day. They will have to complete online evaluation questionnaires regularly. The main objective is to correlate the level of physical activity with the level of fatigue, quality of life and well-being weekly during an anticancer treatment.

Podometer

Maria Cappiello, MD

study to correlate this level of objective physical activity with the levels of fatigue and quality of life in cancer patient being treated.

Study to objectify the level of physical activity of patients by a tool, often used in the global population: the pedometer. Several measurements per questionnaire also will be carried out repeatedly (weekly) in order to correlate this level of objective physical activity with the levels of fatigue and quality of life. The hypothesis we formulate is as follows: the number of weekly steps is negatively correlated with the level of fatigue, positively with the quality of life and well-being.

Number of Weekly Steps, Fatigue, Quality of Life, Well-being During Cancer Treatment: Impact of Recommendations Strengthened by the Provision of Web Interface and Tele-coaching.

Satisfaction With Life Scale (Blais et al, 1989, french-canadian validation, Revue Canadienne des Sciences du Comportement, 21(2), 210-223.)

Positive and Negative Affect Schedule (PANAS scales) (Caci et Baylé, 2007 First traduction in French, Congrès de l'Encéphale, Paris, 25-27 january 2007)

Multidimensional Inventory Fatigue : Gentile et al, 2003, Validation of the French multidimensional fatigue inventory (MFI 20), Eur J Cancer Care)

European Organisation for Research and Treatment of Cancer Questionnaire Quality of Life version 30

Institut Paoli-Calmettes

Aromatase Inhibitors

Home-based walking intervention, wearing a wrist worn activity tracker, for 24 weeks + standard adjuvant AI therapy

Physical activity according to standard recommendations, wearing a wrist worn activity tracker (with no feedback about performed activity), for 24 weeks + standard adjuvant AI therapy

Home-based walking intervention, wearing a wrist worn activity tracker, for 24 weeks

Activity program

Control

Friedemann Honecker, MD

Nicolette Hoefnagels, MSc

The primary aim of the trial is to investigate if a simple outdoor walking intervention, which is practicable under real-life conditions, beginning at the start of adjuvant aromatase inhibitor (AI) therapy, can prevent the occurrence of muscle or joint pain/stiffness in breast cancer patients.

After tumor removal, patients with hormone receptor positive breast cancer tumors often receive adjuvant endocrine treatment, with the use of an aromatase inhibitor (AI) being standard of care in the population of postmenopausal women. Common side effects of AI therapy are joint pain, muscle pain, stiffness, fatigue, hot flashes, and weight gain. Arthralgia and/or myalgia can result in lower physical activity and can negatively influence quality of life (QoL). In addition, muscle or joint pain/stiffness are among the main reasons for non-compliance and discontinuation of AI therapy. Because AI therapy is usually administered for 5 and sometimes even 10 years, this is a major clinical challenge.

For breast cancer patients undergoing AI therapy, physical activity can provide potential benefit by reducing muscle/joint pain and fatigue and can thus improve QoL. The preventive effect of physical activity on AI side effects, however, remains elusive. In addition, activity programs to reduce AI side effects have so far mostly been rather complex. The primary aim of the trial is to investigate if a simple outdoor walking intervention, which is practicable under real-life conditions, beginning at the start of adjuvant AI therapy, can prevent the occurrence of muscle or joint pain/stiffness in breast cancer patients.

Furthermore, this trial will assess the effect of physical activity on symptom burden in general and quality of life in patients receiving adjuvant AI therapy. During the follow-up phase, the trial will assess whether this intervention leads to a sustained change in lifestyle regarding activity, less pain, and better treatment adherence in the intervention group.

1. Home-based walking intervention for 24 weeks + standard adjuvant AI therapy
2. Physical activity according to standard recommendations for 24 weeks + standard adjuvant AI therapy

Activity Program During Aromatase Inhibitor Therapy

A 24 Weeks Activity Program in Patients With Early Breast Cancer Receiving Aromatase Inhibitor Therapy. A Multicenter Randomized Phase III Trial

Muscle or joint pain/stiffness will be assessed at baseline, 3, 9, 12, 15, 18, 21, 24 weeks after randomization by the BPI-SF questionnaire.

The BPI-SF is a 14-item self-administered questionnaire which is routinely used in clinical trials to assess pain severity and pain interference with daily activities in patients with cancer. Pain severity is assessed by four items including pain at its "worst", "least", "average" in the last 24 hours and "now" (current pain), each item being rated on a 0-10 scale.

Fatigue will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Physical scale will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Role scale will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Emotional scale will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Cognitive scale will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Nausea/vomiting will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Pain will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Global health status will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Dyspnoea will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Insomnia will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Appetite loss will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Constipation will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Diarrhoea will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Financial difficulties will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.

Hot flashes will be assessed at baseline, during intervention phase and during follow-up phase via the item 37 of the EORTC QLQ BR-23.

Severity of muscle or joint pain/stiffness will be measured by the four BPI pain severity items. Pain interference will be calculated as the mean of the seven interference items.

During trial intervention phase, daily steps will be measured by a wrist worn activity tracker.

Adherence will be assessed by patient self-report (diary).

Adherence will be assessed by patient self-report (questionnaire completed at visits).

Swiss Group for Clinical Cancer Research

Nutritional and Metabolic Diseases

Obesity

Newsletters, Physical Activity (PA) Prescription Plan, Pedometer

PA Prescription Plan

4 Newsletters with topics based on PA progression phases of adoption and maintenance.

Newsletters

Lorna H. McNeill, PHD, MPH

The goal of this study is to learn why some black and Latino men and women choose not to exercise very often. Researchers also want to learn more about any social and environmental factors that may affect the way an exercise program is followed.

If you chose to take part in this study, you will receive an exercise program, a pedometer, access to a social networking site, and newsletters to help you start becoming more physically active. A pedometer is a small device worn on the hip that counts the number of steps you have taken each day.

Study Visits:

You will come in for study visits 6 times while you are on study; 1 time at the beginning of the study called "screening", 1 time for an orientation visit 7 days after the screening visit, and for follow-up visits at 8, 26, 39, and 52 weeks after you begin the exercise program.

Baseline Tests:

If you are found to be eligible to take part on this study based on the results of the screening tests, the following tests and procedures will be performed:

* You will be asked to complete a computer-based survey. The questionnaires will ask questions about stress, 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 2 hours total to complete.
* Your blood pressure will be measured.
* Your height, weight, and waistline will be measured. To measure your waistline accurately, you may be asked to lift your shirt to expose your stomach area and to lower your pants to expose your mid-hip area. Waistline measurements will only take about 10 minutes to complete and will be performed in a private area.
* You will complete a fitness test. To complete the fitness test, you will either walk a circular path at the clinic for 6 minutes or complete a step test. The study staff will decide which test you will complete and will discuss the test with you in more detail. A study staff member will monitor you during this test.

Study Devices:

At the baseline visit, you will be given the following study devices:

* You will be given a smartphone to take home with you.
* You will fill out a set of questions on the smartphone each time you exercise. The questions will ask about the kind physical activity you are participating in, the location of where the physical activity is taking place, and the weather conditions outside. These questions will take about 1-2 minutes per day. Also, the smartphone will "beep" at random times (3 times per day) and set times (in the morning and evening) throughout the day to prompt you to answer a set of questions about your thoughts and feelings. The device will also automatically record your location using a Global Positioning System (GPS) during the time you are carrying the phone. This will take about 7-8 minutes per day. The research staff will call you 1 time each week to remind you to use the smartphone and will help with any smartphone problems that may occur. Each reminder phone call should last about 3 minutes. You will return the smartphone with you at the orientation visit for the study staff to download your answers.
* You will be given an accelerometer. You will wear the accelerometer for 7 days and then return it at the orientation study visit. An accelerometer is a small device that is worn on your hip that measures the amount of physical activity you do.

Orientation Study Visit:

At the orientation study visit, the following tests and procedures will be performed:

* You will be given a newsletter that contains information and strategies to help you start your exercise program.
* You will be given a smartphone again to take home.
* You will be given a physical activity (PA) prescription. The PA prescription outlines your exercise program and has instructions on the proper way to walk to decrease the chance of getting an injury. You will be instructed to start your PA prescription and carry the smartphone with you for 2 weeks. After 2weeks, you will return the smartphone by mail in a prepaid envelope that will be provided to you by the study staff.
* You will be given a pedometer to wear when you are ready to start your PA prescription.

Weeks 8, 26, 39, and 52 Study Visits:

For each of these study visits, the following tests and procedures will be performed:

* You will return the accelerometer at each visit for the study staff to review, and you will take it home at the end of each visit. The staff member will provide you with the device at your Week 8 visit and you will receive an envelope for return. The smartphone will also be given to you at Weeks 26 and 39, and you will be required to mail it back. For Week 52 you will receive the device 1 week before and return it at your Week 52 visit. You should tell a research staff member right away about any problems you may have using the smartphone.
* You will complete the computer-based survey.
* Your blood pressure will be measured.
* Your height, weight, and waistline will be measured.

You will receive phone calls between study visits to remind you to complete the questions on the smartphone.

At the Weeks 26 and 52 study visits, in addition to the tests and procedures listed above, you will complete the fitness test again and return the smartphone.

Length of Study:

You will remain in the study for up to 1 year. Your participation on this study will be over after you complete the study visit at Week 52.

Other Information:

You may be contacted by phone, mail, text messaging, and/or email at any time while you are taking part in this study to be reminded about the study visits. 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.

This is an investigational study.

Up to 300 participants will take part in this study. All will be enrolled at MD Anderson.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Exercise in Women at Risk for Breast Cancer	NCT00092950	Breast Neoplasm...	Physical activi...	18 Years - 75 Years	National Institutes of Health Clinical Center (CC)
"Prescribing" Exercise to Cancer Patients at High-Risk for Falls	NCT04236154	Cancer	Pedometer Actigraph Perturbation Tr...	18 Years -	Mayo Clinic
Pedometer and Exercise Study in Prostate Cancer Patients With Hormonal Therapy	NCT00868868	Prostate Cancer		18 Years -	Groupe de recherche en Urologie de la Mauricie
Identifying the Role of Symptom Outcomes and Biomarkers in Survival in Patients With Metastatic Pancreatic Cancer	NCT00805688	Pancreatic Canc...	Questionnaires Blood Draws Pedometer	18 Years -	M.D. Anderson Cancer Center
Step Count Monitoring as a Measure of Physical Activity in Patients With Newly Diagnosed Glioma Undergoing Radiation Therapy	NCT04186832	Glioma Radiation Thera...	FitBit Pedometer Quality-of-Life... Questionnaire A...	18 Years -	M.D. Anderson Cancer Center
Use of Pedometer Following Radical Prostatectomy	NCT04206280	Prostate Cancer Ambulation Diff...	Use of a pedome... Standard of car...	18 Years - 75 Years	Benaroya Research Institute
Lifestyle Intervention for High Risk Cancer Survivors	NCT01508273	Breast Cancer	Exercise Progra... Website Exercise DVD Survey Self-Report Ass...	18 Years - 80 Years	M.D. Anderson Cancer Center
Number of Weekly Steps, Fatigue, Quality of Life, Well-being During Cancer Treatment: Impact of Recommendations Strengthened by the Provision of Web Interface and Tele-coaching.	NCT03961451	Cancer, Treatme...	Podometer	18 Years -	Institut Paoli-Calmettes
Exercise in Women at Risk for Breast Cancer	NCT00092950	Breast Neoplasm...	Physical activi...	18 Years - 75 Years	National Institutes of Health Clinical Center (CC)
Use of Pedometer Following Radical Prostatectomy	NCT04206280	Prostate Cancer Ambulation Diff...	Use of a pedome... Standard of car...	18 Years - 75 Years	Benaroya Research Institute
Activity Program During Aromatase Inhibitor Therapy	NCT03786198	Early Breast Ca...	Activity progra... Control	18 Years -	Swiss Group for Clinical Cancer Research
Social Contextual Influences on Physical Activity	NCT01195337	Cancer Prevention Harm...	PA Prescription... Pedometer Newsletters	25 Years - 60 Years	M.D. Anderson Cancer Center
Activity Program During Aromatase Inhibitor Therapy	NCT03786198	Early Breast Ca...	Activity progra... Control	18 Years -	Swiss Group for Clinical Cancer Research

Spots Global Cancer Trial Database for pedometer

Every month we try and update this database with for pedometer 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 pedometer

Every month we try and update this database with for pedometer 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 pedometer 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.