Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Participants come to the Energy Balance Center to exercise 3 times a week for 12 weeks.

Participants receive written materials and instructions on how to perform their exercises.

Participants walk uphill on a treadmill for a total of 33 minutes 3 times a week for 12 weeks.

Participants complete questionnaires about their quality of life, exercise experience, and level of fatigue at baseline and at 12 weeks.

One (1) time each month, participant attends a motivational session.

Participants come to the Energy Balance Center to exercise 3 times a week for 12 weeks.

Participants receive written materials and instructions on how to perform their exercises.

Participants walk uphill on a treadmill or use a stationary bicycle continuously for 41 minutes 3 times a week for 12 weeks.

Participants complete questionnaires about their quality of life, exercise experience, and level of fatigue at baseline and at 12 weeks.

One (1) time each month, participant attends a motivational session.

Participants receive written materials and counseling by an exercise physiologist.

Participants called by a member of the study staff 1 time each week for 12 weeks and asked about any exercise they have done and their weight loss goals.

Participants complete questionnaires about their quality of life, exercise experience, and level of fatigue at baseline and at 12 weeks.

One (1) time each month, participant attends a motivational session.

High-Intensity Interval Training (HIIT) Group: Participants walk uphill on a treadmill for a total of 33 minutes 3 times a week for 12 weeks.There is a 5-minute warm up, followed by four 4-minute intervals. Between each interval, participant walks for 3 minutes. There is a 3 minute cool down.

Moderate-Intensity Continuous Training (MICT) Group: Participants walk uphill on a treadmill or use a stationary bicycle continuously for 41 minutes 3 times a week for 12 weeks.

Exercise

Participants complete questionnaires about their quality of life, exercise experience, and level of fatigue at baseline and at 12 weeks. These should take a total of about 15 minutes to complete.

Questionnaires

One (1) time each month, participant attends a motivational session for 12 weeks.

Motivational Session

Participants called by a member of the study staff 1 time each week for 12 weeks and asked about any exercise they have done and their weight loss goals. Each phone call should take about 15 minutes.

Phone Call

High-Intensity Interval Training (HIIT) Group and Moderate-Intensity Continuous Training (MICT) Group: Participants receive written materials and instructions on how to perform their exercises.

Control Group: Participants receive written materials and counseling by an exercise physiologist.

Printed Materials

Susan C. Gilchrist, MD

The goal of this research study is to learn if there is a level of exercise training that is more effective in lowering biomarker levels that are linked to breast cancer risk. Biomarkers are found in the blood/tissue and may be related to your reaction to exercise.

This is an investigational study. Up to 72 participants will be enrolled in this study. All will take part at MD Anderson.

Study Groups:

If you agree to take part in this research study, you will be randomly assigned (as in a roll of dice) to 1 of 3 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. You will have an equal chance of being assigned to each group:

* If you are in Group 1, you will take part in high-intensity interval (HIIT) exercise.
* If you are in Group 2, you will take part in moderate-intensity exercise.
* If you are in Group 3, you will not take part in any assigned exercise, but you will receive written materials and counseling by an exercise physiologist.

If you are in Group 1 or Group 2, you will also receive written materials and instructions on how to perform your exercises.

Physical Activity:

If you are in Group 1 or 2, you will come to the Energy Balance Center to exercise 3 times a week for 12 weeks.

If you are in Group 1, you will walk uphill on a treadmill for a total of 33 minutes. There will be a 5-minute warm up, followed by four 4-minute intervals. Between each interval, you will walk for 3 minutes. There will be a 3 minute cool down.

If you are in Group 2, you will exercise at the Energy Balance Center 3 times a week. You will walk uphill on a treadmill or use a stationary bicycle continuously for 41 minutes.

If you are in Group 3, 1 time each month while you are on study, you will be called by a member of the study staff and asked about any exercise you have done and your weight loss goals. Each phone call should take about 15 minutes.

The exercise training intensity may be reduced or stopped temporarily if you experience side effects.

Length of Study:

No matter which group you are in, your participation in this study will be over after 12 weeks. You will be taken off study if you have intolerable side effects.

Study Visits:

All participants will visit the MD Anderson Behavioral Research and Treatment Center for each study visit.

At baseline:

* You will have a cardiopulmonary exercise test (CPET) to check your lung function. The CPET checks how well your lungs are working by measuring how much oxygen and carbon dioxide your lungs take in and release when you breathe. To perform this test, you will be asked to walk on a treadmill until you reach a point that you can no longer exercise. You will be breathing into the machine while you walk. This test will take about 30 minutes to complete. The study doctor will be present for each CPET and available to respond to any complication.
* You will have an EKG to check your heart function. The study doctor will be present for each EKG you have.
* Blood (about 1½ tablespoons) will be drawn for biomarker testing. You will be asked to fast (eat nothing and drink only water) for at least 12 hours before each blood draw as part of this study.
* You will have a dual-energy x-ray absorptiometry (DEXA) scan to measure your body mass.
* You will complete a questionnaire that will ask you about your demographics (age, race, and so on), past medical history, and lifestyle habits. This questionnaire should take about 5 minutes to complete.
* You will complete 5 questionnaires about your quality of life, exercise experience, and level of fatigue. These should take a total of about 15 minutes to complete.

At 6 weeks:

* You will have a CPET.
* You will have an EKG.

At 12 weeks:

* You will have a CPET.
* Blood (about 1½ tablespoons) will be drawn for biomarker testing.
* You will have an EKG.
* You will have a DEXA scan.
* You will complete the same questionnaires that you completed at baseline.
* If you are in Group 1 or 2, you will be interviewed by a member of the study staff. You will be asked 5 questions about your experience with your assigned exercise program. It should take about 5 minutes to complete.

One (1) time each month, you will attend a motivational session. During this session, you will discuss strategies for overcoming barriers that may be keeping you from attending or completing your exercises. You will also talk about continuing physical activity after you complete the program. This session should last about 15-30 minutes.

Additional Information:

* Trained health professionals will be present at all study visits to address any symptoms during exercise. If you feel that you are having difficulty breathing, experiencing dizziness, or are having any heart related symptoms while exercising at home, please stop exercising and call 911 immediately.
* Clinical information such as your name, patient medical record number, age, gender, body mass index (BMI), zip code, and your complete medical history will be collected from your medical record.
* If you are in Group 1 or Group 2, you will receive text messages before each exercise session to remind you to attend. You will be responsible for any text messaging charges. Standard text message rates will apply.

High-Intensity Interval Training for Women at Heightened Risk for Breast Cancer

Trials judged feasible if:

At least 45% of screened patients meet inclusion criteria, 2. At least 50% of patients who meet the inclusion criteria consent, 3. Adherence in HIIT and MICT is larger than 80%, and 4. Retention rate is larger than 80%.

M.D. Anderson Cancer Center

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Subjects will receive access to the video library, a Fitbit, a daily adaptive step goal that will be sent via text message with a short positive message; and monthly Zoom meetings, led by the research team, to discuss physical activity with other study subjects.

Subjects will receive access to the video library after the study period (after the 9-month assessment).

Culturally targeted narrative videos will be sent via email.

Narrative videos

A Fitbit activity tracker is a wireless wearable device that monitors physical fitness activity.

A Fitbit activity tracker

A daily adaptive step goal that will be sent via text message with a short positive message.

Daily text message

Monthly Zoom meetings, led by the research team, to discuss physical activity with other study subjects.

Monthly Zoom meeting

Access to Physical Activity Centers Empowerment (PACE) website.

Website access

Printed materials from the American College of Sport's Medicine's "Moving through Cancer" campaign.

Printed materials

Printed materials from the American College of Sports Medicine's "Moving through Cancer" campaign.

Cason E Whitcomb

Jingle Xu, MS

Rachel Hirschey, PhD RN

Rachel Hirschey, Ph.D, RN

This research study tests the feasibility of the Physical Activity Centers Empowerment (PACE) physical activity intervention for African American individuals diagnosed with colorectal cancer.

Feasibility will be measured as intervention reach, effectiveness, adoption, implementation, and maintenance. Seventy-two subjects will be recruited to conduct a pilot two-group, randomized repeated measures study.

The purpose of this research is to improve the quality of life for underserved cancer survivors by increasing physical activity. A physical activity intervention will be tested for feasibility with African American cancer survivors. The project will serve as a foundation for intervening with other underserved cancer survivors.

Feasibility will be measured as intervention Reach, Effectiveness, Adoption, Implementation, and Maintenance, following the RE-AIM framework. Survey and biomarker data will be collected at baseline, 3 and 9 months later. These time points will facilitate exploration of changes pre- and post-intervention, and to determine if effects are maintained 6 months after completing the intervention. Our primary hypothesis is that the intervention will be feasible to deliver.

Physical Activity Centers Empowerment

Physical Activity Intervention Co-created and Tested With African American Colorectal Cancer Survivors

Feasibility Reach- Recruitment is measured by the number of participants screened, ineligible, eligible, enrolled and declined participation.

Retention is measured by the frequency of enrolled participants continued study interventions

Average weekly steps and the frequency of participants achieving daily step goals. Daily steps are collected via Fitbit Inspire activity tracker. Differences in daily steps and the frequency of meeting daily step goals between the intervention and control arms.

Weekly participation in mild, moderate, and vigorous exercise is time spent on physical activity each week is measured subjectively using the Godin Leisure-time Exercise Questionnaire (GLTEQ) and objectively by the Fitbit Inspire activity tracker. The GLTEQ asks participants to self-report how many times they do strenuous, moderate, and mild or light exercise each week and the average duration of exercise. The intervention effectiveness is operationalized by the differences in minutes of doing mild, moderate, and vigorous physical activity between the intervention and control arms.

Daily engagement in sedentary behaviors will be measured as time spent on sedentary behaviors per day is measured subjectively by a 10-option Likert scale called the Sedentary Behavior Questionnaire. Participants are asked to select one of the following options: none,\<=15 minutes, 30 minutes,1 hour,2 hours,3 hours, 4 hours, 5 hours, and 6 hours or more" to estimate the time they spend doing each sedentary behavior on a typical week and a typical weekend day. The behaviors include watching television, playing computer or video games, sitting and listening to music on the radio, tapes, or CDs, sitting and talking on the phone, doing paperwork or computer work, sitting and reading a book or magazine, playing a musical instrument, doing artwork or crafts, and sitting and driving a car, bus or train. The total daily sedentary score ranges from 0 to 81. Daily sedentary time is also recorded objectively by the Fitbit Inspire activity tracker.

Adaption of the study will be measured by the percentage of contacted individuals who meet study criteria to participate in the study.

Implementation of the video library: The percentage of participants who watched study-related video content.

Implementation of using FITBIT: The percentage of days that participants wear the study-issued Fitbits.

The Maintenance will be measured as the differences in intervention effects between intervention and control arms groups 6 months post-intervention (9 months post-baseline).

Outcome expectations will be measured using the modified Multidimensional Outcome Expectations for Exercise Scale, which has an internal consistency of 0.82, 0.84, and 0.81 for physical, self-evaluative, and social outcomes. Differences in outcome expectation scores between the intervention and control arms will be analyzed.

This 5-point Likert scale contains 19 items with the outcome expectation score ranging from 19 to 95. A higher score indicates a higher expectation of doing physical activity for diverse health, cancer, social, and psychological outcomes.

Physical activity knowledge will be measured using a 5-point behavioral capacity Likert scale that assesses participants' knowledge about types, intensity, frequency, and skills of doing physical activity. The knowledge score ranges from 5 to 25. A higher score indicates a higher level of knowledge about doing appropriate physical activity. Differences in knowledge scores between the intervention and control arms will be analyzed.

Self-efficacy will be measured using a nine-item barrier self-efficacy scale and a four-item task self-efficacy scale to assess participants' confidence in overcoming barriers to physical activity and ability to do physical activity. The two self-efficacy scales have Cronbach's alpha of 0.96 and 0.89 among cancer patients, respectively. The total self-efficacy score ranges from The total self-efficacy score ranges from 13 to 65. A higher score indicates a higher level of confidence in overcoming barriers and doing physical activity. Differences in total self-efficacy scores between the intervention and control arms will be analyzed.

Physical activity engagement is measured by a 6-point Likert scale that measures the habit strength for moderate-to-vigorous physical activity. The total habit score ranges from 17 to 102. A higher score indicates a greater engagement in physical activity. Differences in habit scores between the intervention and control arms will be analyzed.

Enjoyment is measured by a short version of the Physical Activity Enjoyment Scale (4-item). The enjoyment score ranges from 4 to 20. A higher score indicates a higher level of enjoyment participants perceive from doing physical activity. Differences in enjoyment scores between the intervention and control arms will be analyzed.

Pain will be measured using a 4-item 5-point Likert pain interference scale from the Patient-Reported Outcomes Measurement Information System (PROMIS) measures. The pain score ranges from 4 to 20. A higher score indicates a higher level of pain interfering with participants' activities. Differences in the pain score between intervention and control groups will be analyzed.

Fatigue will be measured using a 4-item 5-point Likert fatigue scale from the PROMIS measures. The fatigue score ranges from 4 to 20. A higher score indicates a higher level of fatigue. Differences in the fatigue score between intervention and control groups will be analyzed.

Depression will be measured using a 4-item 5-point Likert emotional distress scale from PROMIS measures. The depression score ranges from 4 to 20. A higher score indicates a higher level of depression. Differences in the depression score between intervention and control groups will be analyzed.

Bowel dysfunction will be measured using a 5-point Likert scale from the PROMIS that measures gastrointestinal diarrhea and constipation. The bowel dysfunction score ranges from 15 to 75. A higher score indicates a higher gastrointestinal discomfort participants have. Differences in the score between intervention and control groups will be analyzed.

Sleep quality will be measured using a 4-item 5-point Likert scale from the PROMIS measures. The sleep score ranges from 4 to 20. A higher score indicates a better sleep quality. Differences in the sleep score between intervention and control groups will be analyzed.

Neurotoxicity will be measured using a 4-item 5-point Likert scale from the PROMIS measures. The neurotoxicity score ranges from 4 to 20. A higher score indicates greater neurotoxicity symptoms participants report. Differences in the neurotoxicity score between intervention and control groups will be analyzed.

Quality of life score will be measured using the 36-item Short Form Health Survey. The quality of life score ranges from 0 to 100. The score for each item in the form ranges from 0 to 100 and the average scores of items representing general physical, mental, and social health are calculated, respectively. A higher score indicates better general physical, mental, or social health. Differences in the score between intervention and control groups will be analyzed.

Inflammation biomarkers, including IL-4, IL-10, IL-6, and TNF-α, will be measured by collecting participants' blood samples using the Dried Blood Spot card. The differences in inflammation biomarker levels between the intervention and control groups will be analyzed.

Dietary behaviors are measured by the Rapid Eating Assessment for Participants (Shortened Version, 16 items). The diet score ranges from 1 to 46. A higher score indicates that the participant follows healthier dietary behaviors. Differences in diet scores between the intervention and control arms will be analyzed.

Comorbidities will be measured using the Self-administered Comorbidity Questionnaire. Participants are asked to self-report whether they have or received treatment for 14 common health problems. The comorbidity score ranges from 0 to 28. Differences in comorbidity scores between the intervention and control arms will be analyzed.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
High-Intensity Interval Training for Women at Heightened Risk for Breast Cancer	NCT02923401	Disorders of Br...	Exercise Questionnaires Motivational Se... Phone Call Printed Materia...	18 Years - 55 Years	M.D. Anderson Cancer Center
Physical Activity Centers Empowerment	NCT06411756	Colorectal Neop...	Narrative video... A Fitbit activi... Daily text mess... Monthly Zoom me... Website access Printed materia... Printed materia...	18 Years -	UNC Lineberger Comprehensive Cancer Center
High-Intensity Interval Training for Women at Heightened Risk for Breast Cancer	NCT02923401	Disorders of Br...	Exercise Questionnaires Motivational Se... Phone Call Printed Materia...	18 Years - 55 Years	M.D. Anderson Cancer Center
High-Intensity Interval Training for Women at Heightened Risk for Breast Cancer	NCT02923401	Disorders of Br...	Exercise Questionnaires Motivational Se... Phone Call Printed Materia...	18 Years - 55 Years	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for printed materials