Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Rare Diseases

Fatigue

Breast Neoplasms

Chronic Graft Versus Host Disease

Micronutrients

All Drugs and Chemicals

Vitamins

Herbal and Botanical

Ascorbic Acid

Vitamin C

Orange

Tomato

The FRD maintains a participant on a diet with their typical caloric intake and replaces some of their calories with the following foods on a daily basis; whole grains, vegetables (one leafy green, one tomato, and on yellow/orange), fruit (one high in vitamin C), fatty fish and nuts and/or seeds.

A social cognitive theory intervention method will take place that motivates the participant to change their behavior and lifestyle for overall well being.

Counseling sessions on oral health, healthy eyesight, over-the-counter drug disposal, skin and hair health, cell phone and health, hearing loss, colorectal cancer screening, and preventing colds and flu.

A social cognitive theory intervention method will take place that motivates the participant to change their behavior and lifestyle for overall well being.

Social Cognitive Theory of motivating participants to change their behaviors for overall health and well being.

Social Cognitive Theory

Suzanna M Zick, Nd, MPH

There are over 2 million breast cancer survivors today. Persistent cancer-related fatigue (PCRF), a state of being tired or weary, is one of the most common and distressing symptoms experienced by breast cancer (BC) survivors. PCRF is associated with decreased quality of life, decreased sleep quality, depression, chronic pain and impaired cognition. Currently, there are few treatment options for PCRF and existing treatment options are associated with significant costs, are a considerable burden on the part of the patient, or have unacceptable side-effects. As such, there is a clear need to conduct studies evaluating the impact of safe, easy to implement and inexpensive treatments for PCRF in BC survivors.

Individualized nutritional counseling has been found to be beneficial for decreasing fatigue and improving quality of life in cancer patients receiving treatment.However, there is a dearth of research examining the use of diet for treating fatigue in cancer survivors. Our preliminary data in 40 adult cancer survivors found that fatigue severity was associated with decreased intake of key food groups, e.g., green leafy vegetables, and nutrients, e.g., omega-3 fatty acids, as reported in diet records. However, diet records are often not highly correlated with actual nutrient concentrations in the body and tend to capture short-term dietary habits not long-term patterns. The main objective of this research is to expand upon and confirm our cross-sectional preliminary data and to take advantage of a pilot clinical dietary study we are conducting by examining key nutrient differences in biological samples in the breast cancer survivors. By examining differences in biological samples we will be able to explore three key questions, which will directly influence our future interventional studies: (1) to determine if there are actual differences in concentrations of key nutrients in body tissue and which nutrients these are; (2) to assess if a dietary intervention focused on improving fatigue in BC survivors changes baseline levels of key nutrients; and (3) what is the effect size and variability of change in key nutrients in body tissue both at baseline and after a dietary intervention.

Fatigue Reduction Diet

Fatigue Reduction Diet in Breast Cancer Survivors

Brief Fatigue Inventory(BFI)will be filled out to assess the changes in fatigue at screening, baseline and the final 3 month visit. The BFI assesses the severity of fatigue and the impact of fatigue on daily functioning in patients with fatigue due to cancer and cancer treatment.

Tolerability, goals, beliefs and expectations of participants will be obtained through face to face conversations and over the phone. All counseling sessions will be documented into daily logs for future reference.

University of Michigan Rogel Cancer Center

University of Michigan

Research Associate Professor

Central Nervous System Depressants

Other Dietary Supplements

Benzocaine

Tannic Acid

This arm received an diet intervention designed to maintain changes in fruit and vegetable consumption. The intervention components were based on social cognitive theory and delivered by an automated telephone system.

This arm received an diet intervention designed to maintain changes in fruit and vegetable consumption. The intervention components were based on goal systems theory.

6 mo dietary intervention. This arm received an diet intervention designed to maintain changes in fruit and vegetable consumption. The intervention components were based on social cognitive theory.

This arm received a 6 mo diet intervention designed to maintain changes in fruit and vegetable consumption. The intervention components were based on goal systems theory and delivered by an automated telephone system.

goal system theory

Robert Friedman, MD

The purpose of this study is to test two different approaches to helping individuals who have recently starting eating a healthful diet maintain those healthy changes. This study will deliver a health program using an automated telephone system. The programs will be designed to help individuals maintain a healthy diet change for a lifetime.

RCT is completed. However, the eligibility was 18 y/o or greater and living in Greater Boston area. The participants used an evidenced based dietary intervention for 3 months and then were randomized to 1 of 3 arms. Those in the experimental arm received a 6 mo intervention based on social cognitive theory or goal systems theory. The intervention was designed to help the participants maintain previously achieved changes in the their diet, e.g., fruits and vegetables. The outcome measures are fruit and vegetable consumption as measured by servings on multiple dietary measures as well as a 24 hr dietary recall.

The Study of Automated Telephone Programs for the Maintenance of Dietary Change

Trial of 2 TeleComputer Diet Change Maintenance Programs

University of North Carolina, Chapel Hill

Robert H. Friedman

Professor of Medicine

Skin Neoplasms

Skin Diseases

UV Dosimeter will measure participants' UV exposure for two separate 3-week periods.

Participants will self-report their knowledge and attitudes related to UV exposure. They will then wear a dosimeter for 3 weeks. After, the study team will counsel the participants on their UV levels and exposure, creating a personal plan and advice for avoiding sun exposure before letting the participants wear the dosimeter for an additional 3 weeks.

UV Counseling

Myles Cockburn, PhD

This study aims to characterize UV exposures among NMSC patients (those with a history of skin cancer) and to pilot an innovative behavioral intervention to decrease modifiable UV exposures. It will use UV dosimeters to objectively measure UV exposure and provide time and activity specific UV data on an individual level. These data will be used to develop a targeted and personalized behavioral feedback plan with counseling aimed at effective sun exposure behavior change

The study will focus on helping to prevent NMSC and its associated morbidity through learning when patients are unintentionally exposed to extreme UV radiation. It will then help to create manageable and realistic behavioral interventions to reduce exposure, while also educating patients of the dangers of abundant sun exposure.

Each participant will self-report skin protective behaviors and attitudes before wearing a UV dosimeter for 3 weeks. After the wear period, the study team provides feedback based on UV exposure. The participant will then wear the device again for 3 weeks.

UV Dosimetry Feedback in NMSC Patients

UV Dosimetry Feedback in Non-Melanoma Skin Cancer Patients

Measured using individual dosimeters and comparing it to what participants state they believe their level of sun exposure is

Compare specific sun exposure behaviors responsible for the level of exposure versus what could be done to lessen it

Participants will receive a personalized feedback plan and the success of the plan will be measured through individual dosimetry. We will track real time change in sun exposure based on repeat UV dosimetry.

Track the longitudinal change in sun exposure comparing baseline UV dosimetry measurements to 3 month follow up dosimetry measurements to determine if the changes observed in outcome 3 are maintained.

University of Colorado, Denver

Breast Diseases

attend 12 supervised exercise sessions, attend 6 group sessions with psychologist, attend 3 counseling sessions with exercise specialist

Exercise Behavior Change

Laura Q. Rogers, MD, MPH

"Translation" of the current "basic science" information related to physical activity into patient intervention programs is needed. This translation is critical to providing benefit to the maximum number of patients. Little is known about the determinants of physical activity among breast cancer patients undergoing hormonal therapy and few studies have attempted to evaluate an exercise behavior change program aimed to improve exercise adherence among such patients. The proposed project will evaluate use of an innovative behavioral and psychosocial intervention to increase physical activity among breast cancer patients.

An Exercise Intervention for Breast Cancer Patients: Feasibility and Effectiveness (BEAT Cancer Trial; Pilot Study)

An Exercise Intervention for Breast Cancer Patients: Feasibility and Effectiveness (BEAT Cancer Trial)

University of Alabama at Birmingham

Professor

Dermatologic Agents

Sunscreening Agents

Only "I am Protecting my Child From the Sun" program was given.

The "I am Protecting my Child From the Sun" program was given. After the program, an SMS message was sent on Wednesday and Saturday for 12 weeks. A total of 25 SMS messages were sent to remind the subject and applications.

No attempt was made by the researcher during the study. Only data collection was carried out. At the end of the research, the "I am Protecting my Child From the Sun" program was given..

The parents in the intervention group were administered the "I Am Protecting My Child from the Sun" program for a period of six weeks.

Intervention groups received Sun Protection Guide for Parents, Developmental, Characteristics of 3-6 Age Group Children Brochure, Melanoma Brochure, Video, Frame, Key chain, Magnet, Puzzle, Sunscreen product, T-shirt, hat and UV testing wristband.

I Am Protecting My Child from the Sun

While the education+SMS group, in addition to the program, also received a total of 25 short text messages twice a week.

SMS for sun protection

Selma Öncel, PhD, RN, Professor

This study aimed to examine the effect of the "I Am Protecting My Child from the Sun" program, based on social cognitive theory, on parents' sun-protection product use and sun avoidance behaviors. The "I Am Protecting My Child from the Sun" program, based on Social Cognitive Theory, and the sending of short reminder messages had positive effects on the parents' behaviors related to protecting themselves and their children from the sun.

This study aimed to examine the effect of the "I Am Protecting My Child from the Sun" program, based on social cognitive theory, on parents' sun-protection product use and sun avoidance behaviors. Organized as a randomized controlled experimental study conducted on three groups with a pre- and post-test follow-up design, the study was carried out in Manavgat between April 2018 and October 2018 and included the participation of 185 parents, of which 63 were in the education group, 62 were in the education+SMS group, and 60 were in the control group. The parents in the intervention group were administered the "I Am Protecting My Child from the Sun" program for a period of six weeks, while the education+SMS group, in addition to the program, also received a total of 25 short text messages twice a week. Data were collected using the Parent Information Form, Skin Cancer Risk Perception Form, Skin Cancer and Sun Knowledge Scale, Parental Self-Efficacy Scale, Parental Sun Protection Scales, and Parent Behaviors Regarding Protecting Themselves and Their Children from The Sun Question Form.

I am Protecting my Child From the Sun Program

Effect of the "I am Protecting my Child From the Sun" Program Based on Social Cognitive Theory, on Parent Behaviors

I want to share "I am Protecting my Child From the Sun" program protocol with other researchers.

The Self-Efficacy of the Use of Sunscreen Products consists of 5 items, Norms/Attitudes for the Use of Sunscreen Products consists of 6 items, Expectancies for the Use of Sunscreen Products consists of 6 items and Impediments to the Use of Sunscreen Products consists of 3 items in products; The Self - Efficacy of Sun Avoidance consists of 5 items, Norms/Attitudes for Sun Avoidance consists of 4 items, Tanning Expectancies consists of 4 items and Expectancies for Sun Avoidance consists of 5 items in Parental Sun Protection Scales. To calculate the scores of the scale, the items are numbered from 1 to 5. Each subscale will be evaluated within itself in the scales and it is expected that the scales of Impediments to the Use of Sunscreen Products and Tanning Expectancies scales have low scores and the other scales have high scores.

The questionnaire is prepared according to the literature and consists of Sun Protection Applications of Parents for Themselves and Sun Protection Applications of Parents for Child's sections and five questions. It questions the sun protection practices for sunscreen, long-sleeved clothing, hat, sunglasses and shade. Answers to questions range from "never", " sometimes" and "always".

The Skin Cancer and Sun Knowledge Scale consists of 25 items and evaluates information about five fields: the indications of sun protection, suntanning, skin cancer risk factors, prevention of skin cancer, and skin cancer. The items consist of 15 correct-incorrect and 10 multiple-choice questions. For each item, correct answers are symbolized by (1) and incorrect by (0). Total points are 0-25 on the scale. The higher the score obtained, the higher the knowledge level.

In the Skin Cancer Risk Perception questionnaire, there is a question that questions parents' risk of developing skin cancer, and two questions that question the possibility of developing skin cancer over the next 10 years and their lives. Parents' skin cancer risk perception was grouped between "very low" and "very high" and evaluated between 1 and 10 points, respectively. The increase in the score obtained is interpreted as high risk perception.

Parental Competence Scale consists of 11 items and one dimension to evaluate parents' parenting skills. The lowest 11 points and the highest 77 points can be obtained from the scale.

Skin self-examination practices were obtained by asking.

Akdeniz University

Principal Investigator

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.

Personalized Exercise Program

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Fatigue Reduction Diet	NCT01902745	Chronic Fatigue	Social Cognitiv...	18 Years -	University of Michigan
The Study of Automated Telephone Programs for the Maintenance of Dietary Change	NCT00148525	Cancer	Social Cognitiv... goal system the...	18 Years -	Boston Medical Center
UV Dosimetry Feedback in NMSC Patients	NCT03757663	Non-Melanoma Sk...	UV Counseling	18 Years - 50 Years	University of Colorado, Denver
An Exercise Intervention for Breast Cancer Patients: Feasibility and Effectiveness (BEAT Cancer Trial; Pilot Study)	NCT00721565	Breast Cancer	Exercise Behavi...	18 Years - 70 Years	University of Alabama at Birmingham
I am Protecting my Child From the Sun Program	NCT04251598	Skin Neoplasms Parents Behavior and Be... Child Behavior Health Behavior	I Am Protecting... SMS for sun pro...	-	Akdeniz University
The Study of Automated Telephone Programs for the Maintenance of Dietary Change	NCT00148525	Cancer	Social Cognitiv... goal system the...	18 Years -	Boston Medical Center
Physical Activity After Endometrial Cancer	NCT00501761	Endometrial Can...	Personalized Ex... Questionnaire Suggested Exerc...	45 Years -	M.D. Anderson Cancer Center
Fatigue Reduction Diet	NCT01902745	Chronic Fatigue	Social Cognitiv...	18 Years -	University of Michigan
Physical Activity After Endometrial Cancer	NCT00501761	Endometrial Can...	Personalized Ex... Questionnaire Suggested Exerc...	45 Years -	M.D. Anderson Cancer Center

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