Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

The BSE training program for the early diagnosis of breast cancer will be offered to students in two ways: face-to-face and via web support.

While the training program prepared by the researchers was applied to the intervention group, it was planned that no application would be applied to the nonınterventıon group.

In this study, the training period was determined in two ways:

First; In face-to-face training, each training is planned as four sessions of 45 minutes. Each session is planned with a different purpose and application.

Latter; The system will continue to be open during the training provided through web support and face-to-face training, but the system will be closed to access immediately after the face-to-face training is completed.

Until the research is finalized, no intervention will be made. After the research is finalized, the system will be opened to the nonınterventıon group and the university in general to contribute to their knowledge and awareness.

The BSE training program for the early diagnosis of breast cancer will be offered to students in two ways: face-to-face and via web support.

Content of training Session 1: Topics such as the structure of the breast, the definition of breast cancer, its prevalence, risk factors and symptoms Session 2: Teaching the importance of early diagnosis in breast cancer, the importance and benefits of BSE, the technique of performing BSE, the obstacles to the application of BSE.

Session 3: Teaching the risk factors that cause breast cancer. Session 4: Discussion of case reports of patients diagnosed with breast cancer. Supporting education with web support

Education Intervention

Esra Özer, Asisst. Prof.

Yeşim Çetinkaya, Lecturer

The aim of this study was to examine the effect of web-supported peer education on health beliefs, knowledge levels and breast self-examination in university students.

In line with the general purpose of the study, an experimental design will be used in the study. The population of this study consists of female students of Ankara Medipol University. Considering that there may be dropouts from the study in line with the determined sample size, 200 students (intervention; n=100, control; n=100) who were excluded from the exclusion criteria and who agreed to participate in the study were planned to constitute the study group.

Hypotheses of the Research Between the experimental group and the control group, which received peer education on breast cancer and Breast Self-Examination (BSE); H1a1: There is a difference in terms of the sensitivity subscale score average. H1b1: There is a difference in terms of the mean score of the seriousness/importance subscale.

H1c1: There is a difference in terms of the average score of the benefit perception subscale.

H1d1: There is a difference in terms of the average score of the obstacle perception subscale.

H1e1: There is a difference in terms of the mean score of the trust subscale. H1f1: There is a difference in terms of the health motivation subscale score average.

H2a1: There is a difference in terms of the average knowledge score. H3a1: There is a difference in terms of performing breast self-examination.

Two groups with randomized controlled trial

Web-supported and face-to-face training on breast cancer information and screening will be provided to the experimental group.and outcome assessments will be performed by a investigator who was blinded to group allocation.

The Effect of Web-Assisted Peer Education for Early Diagnosis of Breast Cancer on Health Beliefs, Knowledge Levels and Breast Self-Examination in University Students

Questions from 1 to 12 on the scale; general knowledge about breast cancer; Questions 13 to 20 contain information about the treatability of breast cancer. It also consists of 20 questions that can be answered as "true" or "false". 1 point for each correct answer given; 0 points are given for incorrect answers and blank items. As the score obtained from the scale increases, the level of knowledge also increases.

It is used to determine women's beliefs and attitudes about breast cancer and breast self-examination. Each sub-dimension of the scale is evaluated separately. Champion Health Belief Model Scale (CHBMS) has 6 subscales and is a 5-point Likert type. "Perception of sensitivity" (3 items), "perception of seriousness" (7 items), "perception of benefit" (4 items), "perception of obstacle" (11 items), "trust" (10 items), "Health" regarding breast cancer It has sub-dimensions "motivation" (7 items). The total score of the scale is not calculated. Receiving a low score on the "obstacle perception" subscale and a high score on other subscales shows that women have positive attitudes and beliefs about breast cancer and breast self-examination practices.

This form was used to assess women's ability to perform breast self-examination according to the appropriate stages and their ability to find breast masses. In the form, there are 10 statements including the stages of performing CHBM. Each stage of the examination that is performed correctly is given 10 points, and 0 points are given for incorrect or non-performed stages. Accordingly, a minimum of 0 and a maximum of 100 points are obtained from the form. A score of 90 and above indicates that "CHCMM is performed correctly" and a score of 80 and below indicates that "CHCMM is not performed correctly".

"Can you tell us about how the training has changed your life?", "What has this training added to your knowledge about breast cancer and CHCMM?", "What are the beneficial aspects of this training?" and "What are the aspects of this training that need to be improved?".

Ankara Medipol University

Esra ÖZER

Assist. Proff.

Blood and Lymph Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Education interventions will be delivered sporadically within the 6-month window between the time the clinician completes the pre-survey and when he/she completes the post-survey. Interventions consist of e-brief publications, teleconferences with project faculty, and evidence based resources.

Linda Sutton, MD

This project addresses the need to improve physician knowledge and clinical practice patterns related to quality of life (QoL) concerns for patients with chronic lymphocytic leukemia (CLL).

This multifaceted initiative will include evaluating patient perspectives on their QoL, evaluating provider perspectives on managing QoL, and providing education to the whole CLL care team (hematologists/oncologists, nurse practitioners, physician assistants, and nurses) on contemporary approaches for individualized, patient-centered management of CLL. Providers, including physicians, nurse practitioners, and physician assistants will participate in educational initiatives geared towards enhancing their knowledge and confidence with managing QoL concerns for patients with CLL. Pre and post surveys will be conducted with providers to evaluate change in these areas. The project aims to train this team on how to enhance communication with patients and caregivers as a means to increase patient engagement in care and QoL in this population.

A Quality Improvement Approach to the Management of Chronic Lymphocytic Leukemia

Med-IQ

Gilead Sciences

Genentech, Inc.

Duke University

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Benzocaine

Tannic Acid

Participants attended 4 2-hr education sessions. The overall goal of the sessions was to provide information that would reduce participants' uncertainty about their illness and its treatment, to enhance coping in productive ways with the issues and problems confronting them, and to facilitate communication between the participants and their partners.

Participants attended 4 2-hr nutrition education sessions. Each session provided information and encouragement on setting and attaining measurable goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems in life and living a healthy lifestyle.

Sessions were led by two professionals with expertise in the topic. The sessions began a with presentation of informational material followed by guided discussion of related topics. The first session discussed what to say and not say to children about cancer and how to create a safe environment for them; the second session discussed carrying on with life after the diagnosis of breast cancer, including strategies for managing stress and anxiety and developing meaning in life; the third session talked about how to maintain closeness with a partner and ways to talk about breast cancer; the last session focused on the effects of treatment on reproductive status, and the genetic bases of breast cancer. Participants were also given related booklets and brochures to take home to read.

The nutrition sessions were presented by a professional trained in nutritional science. Sessions included the presentation of information and guided discussion of related topics. The first session discussed information on choosing fruits, vegetables, and low-fat foods and incorporating them into a diet; the second session involved a demonstration of low-fat cooking methods; the third session provided information on the nutritional make-up of a healthy diet and how to shop for it; the last session included information on how to maintain a healthy, low-fat diet while eating out. Women were also asked to keep a four-day food diary, to focus them on their dietary intake and control over it.

Nutrition Education Intervention

Michael Scheier, PhD

RATIONALE: Educational programs may improve coping and quality of life in younger women who have recently been treated for early-stage breast cancer.

PURPOSE: To conduct a clinical trial to determine if an educational intervention and a nutritional intervention could enhance physical and psychological functioning among younger women completing treatment for early-stage breast cancer.

OBJECTIVES:

* Design, implement, and evaluate an educational intervention and a nutrition education intervention specifically aimed at improving adjustment among younger women who have been newly diagnosed with and treated for stage I or II breast cancer and who are ending the active phase of treatment.
* Determine the processes through which the interventions affect quality of life.
* Assess whether the interventions are differentially effective for different groups of women.
* Determine how women who decline participation differ from those who participate.
* Determine the nature and extent of adjustment difficulties, using baseline data, in younger women living in an urban setting who have been treated for early stage breast cancer.
* Identify personality and situational correlates of individuals who adapt well to early-stage breast cancer diagnosis and treatment and those who do not.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 intervention groups or a control condition.

* Arm I (control group): Patients did not undergo any intervention. Patients were evaluated at baseline and at 4 and 13 months.
* Arm II (breast cancer education group): Patients attended a series of approximately 2-hour-long breast cancer education group sessions once a month for 4 months. Sessions involved the presentation of information concerning breast cancer, followed by a guided discussion of related topics. Sessions topics included: talking with children about cancer, life after diagnosis, relationships/intimacy, and hormones and breast cancer/basic factors of heredity. Patients were also given booklets and brochures to read at home. Patients were evaluated at baseline, immediately after the intervention, and at 9 months after the intervention.
* Arm III (nutritional education group): Patients attended a series of approximately 2-hour-long nutritional education group sessions once a month for 4 months. Sessions involved the presentation of information concerning nutrition, followed by a guided discussion of related topics. Session topics included: healthy cupboards, what's cooking, shopping for success, and out on the town. Patients were also asked to keep a 4 day record of diet. Patients were evaluated at baseline, immediately after the intervention, and at 9 months after the intervention.

Educational Program in Younger Women Who Have Recently Finished Treatment for Stage I or Stage II Breast Cancer

Adjustment to Breast Cancer Among Younger Women

Scores for the shortened form of the Center for Epidemiologic Studies Depression scale(CES-D) ranged from 0 (no depressive symptoms) to 24 (high levels of depressives symptoms) in the present sample.

The Perceived Physical Health Component scale of the Medical Outcomes Study Short Form 36 (SF-36) consists of a norm-based weighted average of the following subscales: Physical functioning, bodily pain, role limitations due to physical problems and general health. In the present study, scores ranged from a maximum of 68 (high levels of perceived health) to a minimum of 24 (low levels of perceived health).

The Mental Health Component Scale of the Medical Outcomes Study Short Form 36 (SF-36) consists of a norm-based weighted average of the following subscales: vitality, social functioning, role limitations due to emotional problems and mental health. In the present study, scores ranged from a maximum of 68 (high levels of mental health) to a minimum of 15 (low levels of mental health).

National Cancer Institute (NCI)

Carnegie Mellon University

Professor of Psychology

Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants' uncertainty about their illness/treatment, to enhance coping in productive ways.

Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.

Control Condition

Total

Age, Continuous

Sex: Female, Male

Caucasian

African-American

Other

Race/Ethnicity, Customized

Michael F. Scheier, PhD

Comparison between education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.

Comparison between nutrition education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.

Comparison between education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.

Comparison between nutrition education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.

Baseline

Post-intervention

Final follow-up

All women who agreed to random assignment and completed all three assessments were retained in the analysis regardless of their level of group attendance.

Depressive Symptoms (Measured With an Abbreviated 10-item CES-D) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention).

Comparison between the education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.

Perceived Physical Health (Measured With SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention)

Comparison between education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome

Post-Intervention

Final Follow-up

Mental Health (Measured With the SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention)

Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants' uncertainty about their illness/treatment, to enhance coping in productive ways.

Sessions were led by two professionals with expertise in the topic. The sessions began a with presentation of informational material followed by guided discussion of related topics. The first session discussed what to say and not say to children about cancer; the second session discussed carrying on with life after the diagnosis of breast cancer, including strategies for managing stress and anxiety and developing meaning in life; the third session talked about how to maintain closeness with a partner and ways to talk about breast cancer; the last session focused on the effects of treatment on reproductive status, and the genetic bases of breast cancer. Participants were also given related booklets and brochures to take home to read.

Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.

The nutrition sessions were presented by a professional trained in nutritional science. Sessions included the presentation of information and guided discussion of related topics. The first session discussed information on choosing fruits, vegetables, and low-fat foods and incorporating them into a diet; the second session involved a demonstration of low-fat cooking methods; the third session provided information on the nutritional make-up of a healthy diet and how to shop for it; the last session included information on how to maintain a healthy, low-fat diet while eating out. Women were also asked to keep a four-day food diary, to focus them on their dietary intake and control over it.

Overall Study

Heart and Blood Diseases

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Coronary Artery Disease

Myocardial Ischemia

Coronary Disease

Obesity

Diabetes Mellitus

Ischemia

Heart Diseases

Arteriosclerosis

Arterial Occlusive Diseases

Vascular Diseases

Participants complete interviews over 60 minutes and attend focus groups over 90 minutes in support of intervention adaptation and refinement

Participants receive the Indigenous SIPin intervention over 6 months, which includes in-person and/or virtual educational sessions weekly over 30 minutes for 12 weeks and text message communications BIW for 12 weeks and then monthly thereafter up to month 6.

Interview

Discussion

Rodney Haring

This clinical trial develops and tests a culturally-appropriate educational program (Indigenous SIPin) for reducing sugar-sweetened beverage consumption in men affiliated with Native American athletics communities. Sugary drinks are drinks like pop, soda, and juice. Increased sugar consumption may lead to an increased risk of chronic diseases, including obesity, diabetes, some types of obesity-related cancers, coronary heart disease, hypertension, and dental decay. A culturally sensitive program may help reduce sugar-sweetened beverage consumption in Native American men

PRIMARY OBJECTIVE:

I. Conduct and analyze qualitative data from focus groups and key informant interviews with Native American community members including Native American leaders and community members to develop Sugar Sweetened Beverage (SSB) intervention for Native American men (SIPsmartER Lacrosse).

OUTLINE:

AIM 1: Participants complete interviews over 60 minutes and attend focus groups over 90 minutes in support of intervention adaptation and refinement.

AIM 2: Participants receive the Indigenous SIPin intervention over 6 months, which includes in-person and/or virtual educational sessions weekly over 30 minutes for 12 weeks and text message communications twice a week (BIW) for 12 weeks and then monthly thereafter up to month 6.

A Sugar-Sweetened Beverage Reduction Intervention for Native American Men

A Novel Sugar-Sweetened Beverage Reduction Intervention for Native American Men

Will conduct half hour classes with the Native American community members on how to improve wellness and drink less sugary drinks

change in consumption of sugar sweetened beverages

National Institute of Nursing Research (NINR)

Roswell Park Cancer Institute

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Prostatic Neoplasms

Frailty

ARM I: Patients receive online access to an interactive weight loss website and participate in online group based resistance training sessions (iLIVE) on study. Patients also use a Fitbit fitness tracker and Aria smart scale while on study.

Patients receive usual care with access to online survivorship and exercise recommendations and use a Fitbit fitness tracker and Aria (registered trademark) smart scale while on study.

Participate in online supervised, group resistance training sessions (iLIVE)

Internet-Based Exercise Intervention

Receive online access to an interactive website with a series of weekly self-directed and interactive sessions on various topics associated with diet and weight loss (iLIVE)

Internet-Based Diet Intervention

Receive usual care receiving educational information about diet and exercise for cancer survivors

Carolyn Guidarelli, MPH

Sharon McCoy, MS

Wendy Demark-Wahnefried, PhD

Kerri Winters-Stone

This clinical trial tests the effectiveness of an online weight loss plus resistance training intervention (iLIVE) to decrease obesity and improve frailty in men with prostate cancer who received androgen deprivation therapy (ADT). Androgen deprivation therapy increases the risk of frailty, weight gain and obesity in prostate cancer survivors. The combination of frailty and obesity can lead to a decrease in quality of life and an increased risk of recurrent falls. Using iLIVE may improve obesity and frailty in men with prostate cancer who receive ADT.

PRIMARY OBJECTIVE:

I. To test the effectiveness of a combined online weight loss plus resistance training intervention (iLIVE) on obese frailty in prostate cancer survivors (PCS) on ADT.

SECONDARY OBJECTIVES:

I. To understand the effect of iLIVE on health behaviors, physical functioning, and quality of life II. To understand facilitators and barriers to implementing iLIVE in clinical and community practice

OUTLINE: Patients are randomized to arm I or II. Key stakeholders are identified for implementation outcomes

ARM I: Patients receive online access to an interactive weight loss website and participate in online group based resistance training sessions (iLIVE) on study. Patients also use a Fitbit fitness tracker and Aria (registered trademark) smart scale while on study.

ARM II: Patients receive usual care with access to online survivorship and exercise recommendations and use a Fitbit fitness tracker and Aria (registered trademark) smart scale while on study.

Patients are followed for 6 months after completion of intervention.

Key stakeholders complete an interview while on study to assess barriers and facilitators to implementation of iLIVE into clinical practice.

Outcomes assessors are blinded to participant group assignment after completing the baseline assessment and prior to randomization. Adverse events will be reviewed on a quarterly basis by the research team in a blinded fashion

Internet-Based Lifestyle Intervention (iLIVE) to Eradicate Obese Frailty in Prostate Cancer Survivors

Internet-Based Lifestyle Intervention to Eradicate Obese Frailty in Prostate Cancer Survivors (iLIVE)

Measured from weight assessed on the Aria (registered trademark) scale at the time of the online assessment and self-reported height. Overweight is defined as body mass index \> 25 kg/m\^2 and a 5% loss will be viewed as a successful outcome.

Measured by 30 mg D3 creatine (D3Cr) capsule which they will ingest and then urinate on a test strip on the second void upon waking 3-6 days later. The enrichment of D3Cr will be measured from the test strip along with urine creatine and creatinine. Will use a cutoff of \< 10.75 kg/m\^2 (moderate sarcopenia).

Measured by the fastest time of two 4m walks at a usual pace administered by study staff by remote teleconference. Will use a cut point for "slowness" in older men of speed \< 1.0 m/s - a clinically meaningful cutoff that predicts falls and loss of independence.

Measured by the seconds required to rise from a chair five times, administered by study staff by remote teleconference. Chair stand time \> 12 seconds predicts a 2.4 increased risk of falls in older adults and we will apply this cutoff for "weakness."

Measured by physical activity-related energy expenditure, calculated from self-report on the 41-item Community Health Activities Model Program for Seniors (CHAMPS) physical activity questionnaire. We will use \< 383 kcals per week spent in moderate-vigorous intensity activity as our low activity cut point. Measured also by Fitbit.

Measured using the 4-item short form (SF)-36 Vitality Scale. Will use cut points of scores of \< 50.00 (normed) for prostate cancer survivors (PCS) aged 50-64 years or scores less than 40.00 (normed) for PCS aged 65+ years.

Dietary intake measured using a 2-day diet recalls of 1-weekday and 1 weekend day will be collected by a registered dietitian via telephone and entered into the National Cancer Institute-developed Automated Self-Administered 24-hour. Physical activity measured using CHAMPS as described above. We will also assess free-living physical activity over 7-days using Fitbits.

Measured by Timed Up and Go using a widely used clinical measure of functional mobility that evaluates the time it takes to rise from a chair, walk 3m, turn around, and return and sit in the chair. SF-36 Physical Function measured using a 10-item physical function subscale of the SF-36.

Measured by European Quality of Life-5D with 1 question in 5 separate domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Scores will also be used to calculate Quality of Life Adjusted Years for cost-effectiveness analysis. Healthcare utilization measured using a brief questionnaire that assesses physician and emergency room visits, hospitalizations, etc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effect of Web-Assisted Peer Education for Early Diagnosis of Breast Cancer on Health Beliefs, Knowledge Levels and Breast Self-Examination in University Students	NCT06112158	University Stud... Breast Self-exa... Health Educatio...	Education Inter...	-	Ankara Medipol University
A Quality Improvement Approach to the Management of Chronic Lymphocytic Leukemia	NCT02619604	Chronic Lymphoc...	Education Inter...	-	Duke University
Educational Program in Younger Women Who Have Recently Finished Treatment for Stage I or Stage II Breast Cancer	NCT00416572	Breast Neoplasm...	Education Inter... Nutrition Educa...	18 Years - 49 Years	Carnegie Mellon University
A Sugar-Sweetened Beverage Reduction Intervention for Native American Men	NCT06029517	Cardiovascular ... Coronary Artery... Diabetes Mellit... Obesity-Related...	Education Inter... Interview Discussion	18 Years -	Roswell Park Cancer Institute
A Quality Improvement Approach to the Management of Chronic Lymphocytic Leukemia	NCT02619604	Chronic Lymphoc...	Education Inter...	-	Duke University
A Quality Improvement Approach to the Management of Chronic Lymphocytic Leukemia	NCT02619604	Chronic Lymphoc...	Education Inter...	-	Duke University
Internet-Based Lifestyle Intervention (iLIVE) to Eradicate Obese Frailty in Prostate Cancer Survivors	NCT06011499	Prostate Carcin...	Internet-Based ... Internet-Based ... Education Inter...	-	OHSU Knight Cancer Institute

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