Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Breast Neoplasms

Obesity

Breast Diseases

Skin Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Benzocaine

Tannic Acid

Exercise Intervention: Participants in the Wii Fit exergaming group will have a goal of 150 min/wk of moderate intensity exercise for the last 5 mo of the 6 mo intervention. Heart rate (HR) monitors will quantify exercise intensity. Participants will exercise at a HR equal to 45-65% of their VO2max. Participants will be instructed by the exercise physiologist on how to achieve the required HR. The training will consist of 3 days/wk of supervised Wii Fit physical activity. Exercise duration will increase gradually from 75 to 150 min/wk by wk 477. Thereafter, women will maintain \>150 min/wk of moderate-intensity physical activity. Participants will complete daily exercise diaries recording the type and duration of physical activity, and HR.

Control Group: After baseline testing the control group will be asked to maintain their current daily activities for the duration of the study. The control group will have the option to exercise at the Wii Fit stations following their completion of the study. They will receive the same measures as the exercise group.

The participants in the Wii Fit exergaming group will be encouraged to meet and then maintain a goal of 150 min/wk of moderate intensity exercise for 6 months. Goals per individual will be based on their baseline data. Exercise duration will increase gradually from 75 min/wk at week 1 to 150 min/wk by week 4. Thereafter, women will maintain \>150 min/wk of moderate-intensity physical activity. The training will consist of 3 days/wk of supervised physical activity using Nintendo Wii Fit active videogames.

Exergaming

Lucile L Adams-Campbell, PhD

Overview: This is a 6 month, two-arm randomized clinical trial using comparing exergaming to a control group. The investigators will randomize Black sedentary overweight/obese women to Wii Fit exercise (n=50) or the control arm (n=50). Women in the Wii Fit exercise group will come to the Georgetown community-based exercise facility 3 days/wk. The control group will be asked to maintain their current daily activities and not to exercise for the duration of the study. Based on the investigators previous findings that women who engage in 75-150 mins/wk of brisk walking had an 18% decreased risk of breast cancer, the investigators will target this level of activity in the investigators intervention arm. Also, this 150 min/week of physical activity meets the current recommendations of the American College of Sports Medicine (ACSM) and the US Department of Health and Human Services for healthy individuals and is in line with recommendation of the American Cancer Society (ACS) for cancer prevention.

1. \* Purpose of project (one or two sentences): To examine the feasibility and acceptability of an exergaming intervention in a community-based setting, and to explore the effects of exergaming on cardiovascular fitness, body mass index and percent body fat in Black women who are sedentary and overweight or obese.
2. \* Study design (for example, hypothesis, research questions, standard and experimental procedures/drugs/devices or equipment, etc.):

Overview: This is a 6 month, two-arm randomized clinical trial using comparing exergaming to a control group. The investigators will randomize Black sedentary overweight/obese women to Wii Fit exercise (n=50) or the control arm (n=50). Women in the Wii Fit exercise group will come to the Georgetown community-based exercise facility 3 days/wk. The control group will be asked to maintain their current daily activities and not to exercise for the duration of the study. Based on the investigators previous findings that women who engage in 75-150 mins/wk of brisk walking had an 18% decreased risk of breast cancer, the investigators will target this level of activity in the investigators intervention arm. Also, this 150 min/week of physical activity meets the current recommendations of the American College of Sports Medicine (ACSM) and the US Department of Health and Human Services for healthy individuals and is in line with recommendation of the American Cancer Society (ACS) for cancer prevention.

Exercise Intervention: Participants in the Wii Fit exergaming group will have a goal of 150 min/wk of moderate intensity exercise for the last 5 mo of the 6 mo intervention. Heart rate (HR) monitors will quantify exercise intensity. Participants will exercise at a HR equal to 45-65% of their maximal oxygen consumption (VO2max). Given the expected VO2max values for this population, the investigators project that the Wii Fit videogames must elevate energy expenditure to 3-4 times resting metabolic rate to achieve the desired HR responses. As summarized above, previous studies have shown that such an elevation in energy expenditure can be expected from these activities. Wii Fit stations with a variety of active games will be available to participants at the Georgetown University Community Based Office. Participants will be instructed by the exercise physiologist on how to achieve the required HR. The training will consist of 3 days/wk of supervised Wii Fit physical activity. Exercise duration will increase gradually from 75 to 150 min/wk by wk 477. Thereafter, women will maintain \>150 min/wk of moderate-intensity physical activity. Participants will complete daily exercise diaries recording the type and duration of physical activity, and HR.

Control Group: After baseline testing the control group will be asked to maintain their current daily activities for the duration of the study. The control group will have the option to exercise at the Wii Fit stations following their completion of the study. They will receive the same measures as the exercise group.

Diet: Participants in both groups will be instructed to maintain their diet constant throughout the study. Wii Fit intervention participants will be weighed at every session and those losing more weight than could be accounted for by their exercise will be counseled to return to their caloric intake at the start of the study.

\* Rationale and justification for study (i.e. historical background, investigator's personal experience, pertinent medical literature, etc.): Several risk factors have been identified that increase breast cancer risk, some of which are non-modifiable factors (e.g., age, family history, and race) and some of which are modifiable (e.g., physical activity, body weight, dietary habits, and alcohol intake). However, only within the last 10 years have cancer organizations started to recommend physical activity as a preventive measure for breast cancer. The American Cancer Society (ACS) and the International Agency for Research on Cancer of the World Health Organization now both recommend regular physical activity as a strategy for women to reduce their risk of developing breast cancer. Specific recommendations for breast cancer prevention, which initially focused on diet, are now focused on maintaining a healthy weight throughout life by balancing caloric intake while increasing caloric expenditure via increased physical activity levels, and losing weight if overweight or obese. Obesity itself is a significant public health problem and is associated with increased postmenopausal breast cancer incidence and mortality. This research proposal will assess a novel method to improve physical activity in African American women, who are generally less physically active and more overweight and obese than women of most other racial and ethnic groups.

* Treatment Plan:

The participants in the Wii Fit exergaming group will be encouraged to meet and then maintain a goal of 150 min/wk of moderate intensity exercise for 6 months. Goals per individual will be based on their baseline data. Exercise duration will increase gradually from 75 min/wk at week 1 to 150 min/wk by week 4. Thereafter, women will maintain \>150 min/wk of moderate-intensity physical activity. The training will consist of 3 days/wk of supervised physical activity using Nintendo Wii Fit active videogames.

Participants will exercise at a HR equal to 45-65% of their VO2max. Given the expected VO2max values for this population, the investigators project that the Wii Fit videogames will elevate energy expenditure to 3-4 times resting metabolic rate to achieve the desired HR responses. As summarized above, previous studies have shown that such an elevation in energy expenditure can be expected from these activities. Participants will be instructed to monitor their physical activity in order to assist with their perceived behavioral control and increase self-efficacy towards meeting their goals.

During aerobic exercise sessions, participants will wear Polar heart rate monitors to determine exercise intensity and will be given instruction by the exercise physiologist on how achieve the required HR. In addition, participants will complete daily exercise diaries to record the type and duration of physical activity, and exercise HR. Because many women may not have access to gym memberships or be able to afford expensive exercise equipment, the investigators address this environmental barrier by establishing Wii Fit stations with a variety of active games available to participants at the Community Based Office.

Exergames selected for use during the exercise sessions will be chosen based on energy expenditure data. Those active videogames that have been shown to achieve energy expenditure levels above those necessary to achieve 60% HRmax in the investigators specific study population will be selected. For example, active videogames tested in published studies, such as Wii Fit boxing and Dance Dance Revolution, have been found to achieve physical activity levels of moderate intensity (3.0-6.0 METs), which meet American College of Sports Medicine guidelines for health and fitness. Graves et al. (2008), for example found physical activity levels to reach 68% of maximal heart rate (HRmax) using the Wii Fit which also meets ACSM aerobic fitness recommendations (60% HRmax).

Exergaming Intervention and Breast Cancer Biomarkers in Black Women

Outcomes for plasma leptin, adiponectin, Insulin-like growth factor 1 (IGF-1), Insulin-like growth factor-binding protein 3 (IGFBP3), C-reactive protein (CRP), Interleukin 6 (IL-6), insulin, c-peptide, and Hb-A1c levels at baseline and 24 weeks.

Cardiovascular fitness is measured using metabolic cart at baseline, 12 weeks, and 24 weeks.

Reported stressed levels was assessed using the Perceived Stress Scale (PSS) at baseline, 12 weeks, and 24 weeks.

Georgetown University

Principal Investigator

Syndrome

Metabolic Syndrome

Insulin Resistance

Hyperinsulinism

Metabolic Diseases

Glucose Metabolism Disorders

Each participant will receive a gratitude journal (paperback or electronic journal based on preference) for eight weeks and will have the following journaling prompt to complete at least twice a week: "There are many things in our lives, both large and small, that we might be grateful about. Think back over the day and write down on the line below all that you are grateful for today" (maximum six reasons). The educational goal-setting component will be drawn from the American Cancer Society's Nutrition, Physical Activity, and Cancer toolkit. Participants will be able to choose the order in which they complete the goal-setting modules. Both exercises will be administered daily over eight weeks.

Each participant will receive a journal (paperback or electronic journal based on preference) Participants will receive the following general journaling prompt to complete at least twice a week: "What are some memorable events that happened to you today, big, or small (maximum six memories). Write a brief statement about it.

Gratitude journaling and goal setting for exercise readiness over eight weeks.

Gratitude Intervention

Lakeshia Cousin, PhD, APRN

This pilot study will assess the feasibility of a gratitude intervention to promote physical activity, and well-being and positively impact biomarkers of health among older African American breast cancer survivors. The intervention will also include a goal-setting component to promote exercise readiness and examine the cultural phenomena of the Superwoman schema among Black women.

In this pilot feasibility study, the overall aims are:

Aim 1. Assess the feasibility and acceptability of a gratitude journaling intervention using a pilot randomized controlled trial (RCT) design over eight weeks. We hypothesize that among the 28 participants 1) at least 80% of the participants will report the intervention to be acceptable, 2) biomarker collection will be completed in at least 80% of the surveys and the retention rate will be 80% in each group, and 3) physical activity, health markers, gratitude, well-being, and distress will improve over time.

Aim 2. Describe distributions of outcome variables and effect size for the gratitude journaling intervention on dispositional gratitude, spiritual well-being, psychological distress, exercise readiness, mental and health behaviors in African American/Black women (Superwoman Schema), and inflammatory biomarkers from baseline to post-intervention.

Two-group parallel random-assignment experimental design.

The principal investigator will inform participants of their group assignment and provide intervention details. The research assistant and biostatistician will be blind to group allocation.

Grateful Strides Toward Physical Activity and Well-Being for Black Breast Cancer Survivors

A Pilot Feasibility Study of a Gratitude Journaling Intervention to Enhance Well-being and Exercise Readiness in Older African American Female Breast Cancer Survivors

Percentage of women who meet the inclusion criteria relative to the number of women approached.

Percentage of participants completing baseline assessment measures.

Percentage of participants who completed baseline assessments and completed the post-intervention assessments.

We will assess treatment satisfaction using the mean Client Satisfaction Questionnaire(CSQ-8) scores. An overall score is calculated by summing the respondent's rating score for each scale item. Scores range from 8 to 32, with higher values indicating higher satisfaction.

The effect size of dispositional gratitude measured at week 0/baseline and post-intervention/week 8 will be measured using the Gratitude Questionnaire-6 designed to measure four facets of dispositional gratitude: (a) intensity, (b) frequency, (c) span, and (d) density. Each item is rated on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree). Higher scores mean higher dispositional gratitude.

The effect size of spiritual well-being baseline/week 0 and post-intervention/week 8 will be measured using the Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale designed to assess spiritual well-being over the past seven days in a population with a chronic illness. Items are rated on a Likert-type scale ranging from 0 (not at all) to 4 (very much). Higher scores indicate enhanced spiritual well-being.

The effect size of distress baseline/week 0 and post-intervention/week 8 will be measured using the Perceived Stress Scale designed to measure stress during the last month. The scale consists of 10 items rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often) during the last month. Higher scores indicate more distress during the last month.

The effect size of the Superwoman schema baseline/week 0 and post-intervention/week 8 will be measured using the Giscombe Superwoman Schema Questionnaire developed to measure components prominent in the superwoman schema construct. The Giscombe Superwoman Schema Questionnaire (G-SWS-Q) was developed to measure components prominent in the superwoman schema construct. It contains 35 statements rated from 0 (not true) to 4 (true all the time) across the 5 subscales of (1) obligation to present an image of strength, (2) obligation to suppress emotions, (3) resistance to being vulnerable, (4) intense motivation to succeed and (5) obligation to help others. Higher scores indicate higher agreement with the identity.

The effect size of exercise readiness baseline/week 0 and post-intervention/week 8 will be measured using the Stage of Motivational Readiness for Physical Activity questionnaire, a highly reliable instrument with items that classify a person as being in the pre-contemplation, contemplation, preparation, action, or maintenance stage of exercise behavior change based on the selection by the participant.

The effect size of inflammatory biomarkers baseline/week 0 and post-intervention/week 8 will be measured using a Luminex panel containing Tumor Necrosis Factor Alpha (TNF-α), Interleukin 6 (IL-6), Growth/Differentiation Factor-15 (GDF15), and Enzyme-linked immunosorbent assay (ELISA) kit containing C-Reactive Protein.

National Institute on Aging (NIA)

University of Florida

Participants in this group will receive education about breast cancer prevention and specific information about African American women and breast cancer risk.

Participants in this group will receive general information about breast cancer prevention without anything specific to African American women.

Participants will be randomized to either the evidential or non-evidential group. Both groups will receive primarily the same information, except one group will receive information that is more tailored to African American women, while participants in the other group will receive general information about breast cancer prevention.

Comparison of evidential versus non-evidential education on women's breast cancer prevention behaviors

Chanita H Halbert, PhD

We will develop and evaluate a community-based approach for disseminating comparative effective reviews (CERs) about breast cancer prevention to African American women. The specific aims of our research, as shown below, will target this population because of persistent disparities in breast cancer morbidity and mortality among this population. Our primary aims are:

1. To evaluate uptake of a community-based strategy for disseminating CERs about breast cancer prevention to African American women based on sociodemographic characteristics, beliefs about medical research, and medical history. We predict that participation in a community forum will be higher among women with greater socioeconomic resources, those who have a family history of breast cancer, and women who have more positive beliefs about research.
2. To evaluate the impact of evidential versus non-evidential content about breast cancer prevention on psychological and behavioral outcomes that include: knowledge of breast cancer risk factors and prevention strategies, communication with individuals in their social and medical network, and distrust of medical research. We predict that women who receive evidential content that is specific for African American women will report greater knowledge about breast cancer risk factors and prevention strategies, will be more likely to discuss breast cancer prevention strategies with individuals in their social and medical network, and will report greater reductions in distrust of medical research compared to those who receive non-evidential content.

Breast Cancer Prevention Education

Disseminating Breast Cancer Prevention to African American Women

Assessment of participants' attendance at a session.

Measurement of women's knowledge about breast cancer prevention at three and six months post intervention compared to baseline measurements.

Assessment of the extent to which women discuss breast cancer prevention with their health care providers at three and six months post intervention compared to at baseline.

Assessment of the extent to which participants harbor distrust for the medical establishment three and six months post intervention compared to at baseline.

Assessment of the relationship between participants' education and primary outcomes.

Assessment of the relationship between participants' family history and the primary outcomes.

Assessment of the relationship between participants' beliefs about research and the primary outcomes.

University of Pennsylvania

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

The video podcast will deliver cervical cancer prevention messages using entertainment education and behavioral journalism, and film production techniques such as "talking head" video, interview, animations, \& live-action skits. The research team will work closely with the production company in scripting the video vignettes and sequences, ensuring that video content reflects salient domains captured in the concept mapping research development phase of the study.

Cervical cancer podcast for African American women

Chakema C Carmack, Ph.D.

For African American women (AAW) in Houston, cervical cancer mortality is disproportionate to their racial and ethnic counterparts.Most notably, lack of human papillomavirus (HPV) screening, vaccination, and later diagnosis increase cervical cancer mortality. However, cervical cancer is largely preventable. While previous research has identified only a few social determinants that are specifically related to cervical cancer, there may be a host of additional social and cultural factors that contribute to a lack of preventative behavior. The overall objective of the proposed study is to gather preliminary data to determine whether the use of concept mapping methodology is useful in identifying unique sociocultural determinants of cervical cancer prevention behavior, and to pilot test the feasibility of a podcast video developed using the information garnered from the concept mapping procedure. It is hypothesized that the resulting podcast video will increase HPV knowledge and behavioral intentions. Proof of concept and feasibility are needed first, in determining the utility of both the methodology and media development procedures, as well as data on preliminary effect outcomes, before further investigation and program development.

Podcasting Cervical Cancer Prevention for AAW

Proof of Concept and Feasibility in Podcasting Cervical Cancer Prevention for African American Women

Because this is a feasibility study with a very low sample size, the data is preliminary and it is not certain that the data will be appropriate or useful for public dissemination.

To observe whether the podcast video significantly changed perceptions of cervical cancer prevention.

Items will be set to 5-pt Likert-type scale: (1) - (5); higher scale values indicating more positive perceptions to cervical cancer prevention

To observe whether the podcast video significantly changed intentions to obtain a Pap cytology test.

Item will be set to 5-pt Likert-type scale: (1) - (5); higher scale values indicating greater intentions for cervical cancer screening.

For women who are within the HPV vaccination age range: to observe whether the podcast video significantly changed their intentions to obtain a HPV vaccination.

Items will be set to 5-pt Likert-type scale: (1) - (5); higher scale values indicating more positive intentions toward HPV vaccination.

University of Houston

Associate Professor

* Will be asked to choose 2 social contacts (adult family member or friend identified by the participant as someone who could be engaged by the research team to encourage the participant to attend her mammogram appointment)
* Will receive reminder(s) from social contact about the screening mammogram appointment
* Will receive reminder from Breast Health Center about screening mammogram appointment
* Will be contacted to provide experience with the study

* Facilitate enrolled patient to complete the screening mammogram.
* Will receive information about screening mammograms and resources available at the Breast Imaging Center.
* Will be contacted approximately 3 days prior to the patient's mammogram appointment.
* Will be contacted to provide experience with the study

-The social contact will remind patient about screening mammogram appointment

Social Contact Reminder

Whitney Hensing, M.D., M.S.

Eliminating racial disparities in breast cancer is a top public health priority. African American (AA) women often present with more advanced and aggressive disease at the time of diagnosis and are more likely to die from breast cancer than any other racial/ethnic group in the United States. Mammogram screening significantly reduces breast cancer mortality by diagnosing cancer at an earlier stage where treatments are more effective. While some AA women do not schedule screening mammograms as recommended by current guidelines, others do not show up for their exams after scheduling them (no-shows). No-shows to cancer screening appointments impose an enormous strain on our limited healthcare resources with negative impact on other patients who could have secured earlier appointments, loss of revenue for hospitals or clinics serving underserved populations and delays in diagnoses and treatment for those who do not have screening. The investigators identified a high no-show rate for screening mammograms at our hospital. AA women were almost three times more likely to no-show for their mammograms compared to White women. Patient's social networks plan an important role in health promotion. In this study, we will pilot an intervention involving patient's social contacts (family, friends, neighbors, etc.) as healthcare facilitators to improve appointment attendance. The investigators seek to determine whether this intervention is feasible and acceptable to patients and whether this intervention will improve attendance rates for screening mammograms among AA women at our institution. If effective, the use of a patient's social contact person as a healthcare facilitator (similar to a patient navigator) would be a readily available and inexpensive resource for other institutions to implement.

Utilizing Social Contacts to Facilitate Mammogram Screening Among African American Women

Pilot Study Utilizing Social Contacts to Facilitate Mammogram Screening Among African American Women

-The study is deemed feasible if 80 participants are enrolled to the study and further, if at least 65% of the 80 participants will have a social contact agreeing to participate

-Use descriptive statistics to present the characteristics of social contacts and regression analysis to determine in association with social contact characteristics and appointment attendance.

-Use descriptive statistics to present response to structured interview questions.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Exergaming Intervention and Breast Cancer Biomarkers in Black Women	NCT02152462	Breast Cancer Obesity	Exergaming	40 Years - 59 Years	Georgetown University
Grateful Strides Toward Physical Activity and Well-Being for Black Breast Cancer Survivors	NCT05473026	Cancer Survivor... African America... Women Psychology, Pos... Cardiometabolic... Exercise Feasibility Stu... Breast Neoplasm...	Gratitude Inter...	50 Years - 99 Years	University of Florida
Breast Cancer Prevention Education	NCT01299623	Breast Cancer P...	Comparison of e...	35 Years - 70 Years	University of Pennsylvania
Podcasting Cervical Cancer Prevention for AAW	NCT05359913	Cervical Cancer	Cervical cancer...	18 Years -	University of Houston
Utilizing Social Contacts to Facilitate Mammogram Screening Among African American Women	NCT05275361	Breast Cancer	Social Contact ...	40 Years -	Washington University School of Medicine
Utilizing Social Contacts to Facilitate Mammogram Screening Among African American Women	NCT05275361	Breast Cancer	Social Contact ...	40 Years -	Washington University School of Medicine
Breast Cancer Prevention Education	NCT01299623	Breast Cancer P...	Comparison of e...	35 Years - 70 Years	University of Pennsylvania
Podcasting Cervical Cancer Prevention for AAW	NCT05359913	Cervical Cancer	Cervical cancer...	18 Years -	University of Houston

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