Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Neoplasm Metastasis

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Neoplastic Processes

The PEP intervention involves a combination of home-based exercise as well as in-patient exercise. The exercise modes will include basic transfer and calisthenics mobility, aerobic and resistance exercises and will be performed in various postures (supine, sitting, standing and walking) with variable challenges (level walking, bending, inclines, steps and squatting).

For patients randomized to the Intervention Group (Group 1), the PEP intervention will be personalized, implemented, and modified (based on the patients AM-PAC mobility stage) by a licensed physical therapist in face-to-face, virtual, or phone meetings (\~30-40 minutes). An exercise education manual, specifically developed for this study, will be used by the physical therapist to educate the patients on all aspects of starting and maintaining the exercise intervention.

Personalized Exercise Program

This is a Phase 3 study aimed at investigating the effects of a personalized exercise program (PEP) in NSCLC patients (stage I, II, IIIa) and secondary lung cancer patients undergoing surgical treatment at the University of Utah and comparing the intervention to the current standard of care (no exercise program).

This is a Phase 3 study aimed at investigating the effects of a personalized exercise program (PEP) in NSCLC patients (stage I, II, IIIa) and secondary lung cancer patients undergoing surgical treatment at the University of Utah and comparing the intervention to the current standard of care (no exercise program).

Eligible patients will be randomized between two arms (1:1 ratio) prior to the surgery and will be followed for approximately 6 months post-surgery:

* An Intervention Arm (referred to in materials as Group 1) which features pre- and post-surgery PEP interventions.
* A Control Arm (referred to in materials as Group 2) which does not include a personalized exercise program (the standard of care). Patients randomized to the Control Arm will be given the opportunity to participate in a PEP-intervention session providing exercise counseling after the 6 month assessment and will receive a free activity tracker for their participation.

Precision-exercise-prescription for Lung Cancer Patients Undergoing Surgery: The PEP Study

A Phase III Randomized Study Comparing the Effects of a Personalized Exercise Program (PEP) Against No Intervention in Patients With Stage I-IIIa Primary Non-Small Cell Lung Cancer or Secondary Lung Cancer Undergoing Surgical Resection

Six Minute Walk (6MW) distance.

The distance patients can walk indoors on a 25 meters level smooth-surfaced track over the course of 6 minutes will be measured at baseline as well as at the time of discharge and at the 2 and 6 months follow-up.

Short Physical Performance Battery (SPPB) test scores

A secondary endpoint associated with the evaluation of improvement in physical performance is the result of the short physical performance battery test. The SPPB score (ranging from 1 to 12) will be obtained for each patient at the time points described above. Medians will be obtained and compared for each arm.

Results from FACT-L (Functional Assessment of Cancer Therapy-Lung) questionnaire

Results from FACIT-F (Chronic Illness Fatigue Scale) questionnaire.

Results from PSQI (Pittsburgh Sleep Quality Index) questionnaire.

Results from BREQ-3 (Behavioral Regulation in Exercise Questionnaire 3) questionnaire.

National Cancer Institute (NCI)

National Institutes of Health (NIH)

University of Utah

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Healthy participants that have no history of invasive cancer.

Walking up to thirty minutes on most days of the week.

Questionnaires regarding physical activity, exercise, and quality of life.

Questionnaire

Suggested Exercise Program

Karen Basen-Engquist, PhD

Researchers propose to apply Social Cognitive Theory to improve understanding of the mechanisms of physical activity adherence for endometrial cancer survivors participating in a physical activity intervention.

The specific aims of the study are:

1. To test a Social Cognitive Theory-based model of physical activity adoption among sedentary endometrial cancer survivors receiving an intervention to increase physical activity. The model includes hypotheses about the effect of self-efficacy and outcome expectations on physical activity adherence, the effects of four sources of efficacy information (mastery experience, verbal persuasion, modeling, and physiological feedback) on self-efficacy and subsequent exercise adherence, and the influence of physical activity outcomes on subsequent self-efficacy, outcome expectations, and physical activity.
2. To elucidate the influence on self-efficacy of cardiorespiratory fitness and somatic sensations while engaging in physical activity.
3. To determine whether the received dose of an intervention based on Social Cognitive Theory is related to physical activity adherence.
4. To test the effects of adherence to physical activity on endometrial cancer survivors' quality of life and stress as assessed by self-report and salivary cortisol.
5. To test the feasibility of a web-based maintenance intervention for women who have completed the phone counseling portion of the study.

Women who have been successfully treated for endometrial cancer will be invited to participate in the study. After you agree to participate you will be asked questions about your physical activity to make sure you are eligible. You will only be allowed to participate in this study if your physician feels it is safe for you to engage in moderate physical activity, so you will be asked to have him or her complete a form about your health conditions. Information about you cancer and treatment history will be collected from your medical records as part of the study.

If you agree to take part in this study, you will come to M. D. Anderson for study visits twice at the beginning of the study. If needed, the activities for these first 2 visits can be combined into 1 visit, though it will mean that the single visit will take a little longer than each of the 2 visits. After the first visit, you will be asked to return after 2, 4, and 6 months. Each visit will take about 2 hours. Three (3) months and 6 months after the last visit, you will be called to answer questions about your physical activity. It will take about 10 minutes to answer the questions. In case you cannot be reached by phone, the questionnaires will be mailed to you. You will be asked to mail the questionnaire back in with a pre-paid addressed envelope.

At the first visit you will complete questionnaires about your quality of life, medical conditions, and how physically active you are currently and have been in the past. The questionnaires will take about 45 minutes to complete. A baseline electrocardiogram (ECG-a test to measure the electrical activity of the heart) will be performed. If your ECG test is not normal you will be informed. You will practice using the exercise bicycle that will be used in the fitness testing at the later visits. You will be asked to provide a saliva sample by placing a cotton roll in your mouth until it is saturated and then placing it back in a plastic vial without using your hands. This sample will be for practice and will be discarded.

You will also be given an ActiGraph to wear for 5 days. This is a small light device that you wear on your waist during the day. It records how active you are. You will also be given a handheld computer that you will use for 5 days to answer questions about physical activity. The computers are small (about 4-1/2 by 3 inches) and light (about 4 1/2 ounces). The computer will prompt you to enter information up to 8 times a day. Answering these questions will take up to 5 minutes. You will be asked to return the Actigraph and the computer on your second visit.

After 5 days, you will come back to M. D. Anderson for your second study visit. During this visit, you will be asked to complete questionnaires about physical activity that will take about 1 hour. You will have an electrocardiogram (ECG--a test to measure the electrical activity of the heart) performed. You will perform a fitness test, in which you will ride a stationary bicycle while your heart rate, blood pressure, and respiration (breathing) are monitored. You will also be asked to complete two tasks on a computer. After the second visit, you will again use the handheld computer and wear an Actigraph for 5 days. You will also be given 10 vials with a container bag and instructions on collecting saliva samples. You will be asked to provide saliva samples 5 times per day for 2 consecutive days.

During your second visit, you will meet with an exercise physiologist, a specially-trained health care professional who will design a personalized exercise program for you, that will involve walking (up to 30 minutes) on most days of the week. If walking is difficult or painful for you, another form of exercise will be substituted. In addition to receiving a personalized exercise program, you will also receive telephone counseling between your visits to M. D. Anderson and printed materials. Both will provide information and support for your exercise program. The telephone counseling calls will take place once a week during the first 2 months, every other week during Months 3 and 4, and once a month during Months 5 and 6. The phone counselor will talk to you about your exercise program and how it is working for you. The telephone calls will take place at a time that is convenient to you, and will take about 15-20 minutes each time. Some of these telephone counseling calls may be audiotaped, so that the counselors' supervisors can make sure the counseling is done correctly.

During each of the 2-month, 4-month, and 6-month clinic visits (Visits 3, 4, and 5), you will do another fitness test, and any necessary adjustments to your exercise program will be made. This means that if the goals for exercise were set too high or too low, how often the exercise occurs or how long each exercise session lasts will be changed. For example, if the exercise physiologist first recommended that you walk for 15 minutes a day 5 days a week, but you report that you can't walk for 15 minutes, the length of the walk may be reduced. You will also fill out the questionnaires and do the tasks on the computer at these visits. You will complete a brief (5 minutes) program evaluation. You will also be asked to answer questions on the handheld computer for 5 days before and after each these visits. You will also be asked to wear the Actigraph for 5 days before and after each of these visits. At the last visit, you will also be given 10 vials with a container bag and instructions on collecting saliva samples. You will be asked to provide saliva samples 5 times per day for 2 consecutive days. The study staff will give you a prepaid mailing envelopes so you can return the computer, the Actigraph, and the package of vials to them by mail, after the last 5-day period.

This is an investigational study. Up to 326 participants will be enrolled for this study. For the pilot phase, which has been completed, 22 endometrial cancer survivors and 37 comparison participants with no history of cancer were enrolled. For the main phase of the study, for which you are enrolling, up to 267 endometrial cancer survivors will be enrolled. All will be enrolled at M. D. Anderson.

Saliva samples 5 times per day for 2 consecutive days.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Precision-exercise-prescription for Lung Cancer Patients Undergoing Surgery: The PEP Study	NCT03306992	Non Small Cell ... Secondary Lung ...	Personalized Ex...	18 Years -	University of Utah
Precision-exercise-prescription for Lung Cancer Patients Undergoing Surgery: The PEP Study	NCT03306992	Non Small Cell ... Secondary Lung ...	Personalized Ex...	18 Years -	University of Utah
Physical Activity After Endometrial Cancer	NCT00501761	Endometrial Can...	Personalized Ex... Questionnaire Suggested Exerc...	45 Years -	M.D. Anderson Cancer Center
Physical Activity After Endometrial Cancer	NCT00501761	Endometrial Can...	Personalized Ex... Questionnaire Suggested Exerc...	45 Years -	M.D. Anderson Cancer Center

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