Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

All participants perform:

conventional breast examination path (i.e., screening mammogram, integrated with other radiological/histological output when deemed necessary by the responsible Investigator in each site) AND MammoWave exam.

Women undergoing conventional breast screening examination will be asked by the clinical staff if they are interested in taking part in the study.

A short visit should be performed to check the inclusion/exclusion criteria, review demographic data, and the volunteer's medical history. After performing this visit, the volunteers will perform the MammoWave exam on both their breasts.

The exam will be composed of two phases: data acquisition and data processing. During the acquisition, which should take about 8 minutes, the volunteers would be lying down in a prone position, on the bed which is part of MammoWave.

When the acquisition is completed, the data will be processed through a dedicated microwave imaging algorithm. The output will be composed of microwave images, plus parameters describing the images. MammoWave output will also comprise a label obtained using an optimized classification algorithm.

MammoWave

Gianluigi Tiberi

Sabatino Tiberi

Riccardo Loretoni

Massimo Calabrese

Alberto Stefano Tagliafico

Jan Lubinsky

Filipa Lourenço Cardoso

Celeste Alves

Maria Antónia Vasconcelos

Ângelo Passos

Marina Álvarez Benito

María Martínez Gálvez

Este Correo

Daniel Alvarez Sánchez-Bayuela

Cristina Romero Castellano

Thomas Frauenfelder

Jann Wieler

This is an open, multicentric, interventional, prospective, non-randomized clinical investigation. The first aim of the study is to confirm that MammoWave reaches sensitivity\>75% and specificity\>90% in breast cancer (BC) detection on 10.000 volunteers undergoing regular screening programs.

MammoWave is a non-CE marked device that uses low-power (1mW) microwaves (1-9 GHz) instead of ionizing radiation (X-ray) for BC screening. MammoWave uses safe low-power radio frequency signals in the microwave band; it is a Class IIa medical device (non-invasive device). The previous generation of MammoWave had obtained the CE mark; in this investigation, the device contains the same hardware and will be used with the same acquisition method as the CE marked device, but additional data processing software will be used.

The 10,000 volunteers undergoing conventional breast screening examination will also undergo the MammoWave exam. The MammoWave results (WSF: breast With Suspicious Finding,i.e. with suspicious lesion, or NSF: No Suspicious Finding, i.e. breast without lesion or with low suspicious lesion) will be checked against the Reference Standard, to be intended as the output of conventional breast examination path (i.e., screening mammogram, integrated with other radiological/histological output when deemed necessary by the responsible Investigator in each site). Reference Standard may be BC+ for the histology-confirmed breast cancer (BI-RADS 6); BC- otherwise (BI-RADS 1, 2, 3).

(NOTE: BIRADS 4 and 5 are only image suspicion criteria: when a biopsy is performed, BIRADS are transformed in 6 (BC+) or 1,2 and 3 (BC-))

This clinical trial is performed within MammoScreen project \[1\] awarded in the context of HORIZON-MISS-2021-CANCER-02-01. UBT Srl is a partner of a Consortium which comprises (in addition to UBT): Toscana Life Sciences Foundation (Italy); London South Bank University (UK); ELAROS 24/7 Limited (UK); Servicio De Salud De Castilla La Mancha (Spain); Scuola IMT Alti Studi Lucca (Italy); EVITA - Cancro Hereditário (Portugal).

Clinical Investigation with class IIa medical device

A Clinical Investigation to Evaluate Microwave Imaging Via MammoWave® in a Population-based Screening Program for Early Breast Cancer Detection

A Multicentric, Prospective Clinical Investigation to Evaluate Microwave Imaging Via MammoWave® in a Population-based Screening Program for Early Breast Cancer Detection to Make Breast Cancer Screening More Accurate, Inclusive, and Female-friendly

MammoWave® sensitivity (percentage of 'true positive' results) while using an optimized classification algorithm. The Reference Standard is intended as the output of conventional breast examination path (i.e. screening mammogram, integrated with other radiological/histological output when deemed necessary by the responsible Investigator). Reference Standard may be: BC+ for the histology-confirmed and classified as BI-RADS 1,2 or 3.

MammoWave® specificity (percentage of 'true negative' results) while using an optimized algorithm.

Evaluation of the detection rates (sensitivity) according to the type of radiological finding (microcalcification, mass, asymmetry or architectural distortion group), also by breast density (according to BI-RADS ACR classification assigned by the radiologist), and comparison with the other standard screening and diagnostic modalities.

Evaluation of MammoWave recalls, also by breast density (according to BI-RADS ACR classification assigned by the radiologist), and comparison with the other standard screening and diagnostic modalities.

Evaluation of MammoWave positive predictive value (for the biopsies performed), also by breast density (according to BI-RADS ACR classification assigned by the radiologist), and comparison with the other standard screening and diagnostic modalities.

Program screening rate, calculated as the proportion of women diagnosed with BC in the study population

BC detection rates of each by histological type and size of the BC and BI-RADS classification, also by breast density

Evaluation of the improvement in both sensitivity and specificity when retrospectively using AI algorithms for the evaluation of MammoWave® data after its further optimization with all data collected in the participants included in the study.

Evaluation of the reproducibility of results comparing the lectures performed at the study centers and the centralized lectures

Volunteers' satisfaction through a properly designed questionnaire collecting women's issues and plus during the exam with MammoWave® in the language spoken by the women

Toscana Life Sciences Sviluppo s.r.l.

London South Bank University

ELAROS 24/7 Limited (UK)

Servicio De Salud De Castilla La Mancha (Spain)

IMT School for Advanced Studies Lucca

EVITA - Cancro Hereditário (Portugal)

Umbria Bioengineering Technologies

The women in the experimental group (n=60) will be given 16 hours of breast cancer screening training, two days a week, two hours a day (60 min+60 min) for four weeks, by the researchers.

No application will be made to the control group (n=60).

Breast Cancer Education

The lack of knowledge of women on breast cancer and health literacy poses a major obstacle to people's breast cancer screening behaviors and beliefs. In order to increase social sensitivity and awareness on this issue; In particular, it is important to research, examine and examine how the municipalities and their employees, who are representatives of the society, evaluate breast cancer screening studies. The aim of our project is to evaluate the effect of breast cancer screening training given to women working in the municipality on health literacy, breast cancer screening belief and behavior. This study will be conducted in a randomized-controlled experimental design with women (n=120) working in a municipality in Istanbul Province between November 2022 and November 2023. Data will be obtained face-to-face using the Participant Information Form, the Health Literacy Scale and the Breast Cancer Screening Beliefs Scale. The women in the experimental group (n=60) will be given 16 hours of breast cancer screening training, two days a week, two hours a day (60 min+60 min) for four weeks, by the researchers. No application will be made to the control group (n=60). Follow-up evaluations of the research will be completed in the following six months. The Health Literacy Scale and Breast Cancer Screening Beliefs Scale will be re-administered to all women in the experimental and control groups at the first follow-up after three months and at the second follow-up after 6 months. The data will be analyzed with statistical methods and the effectiveness of the training will be evaluated.

When the project is concluded; The results will be presented as an article in a national or international journal, or as an oral presentation at a national or international congress. It will be ensured that breast cancer screening training given to women working in the municipality will increase their level of health literacy, have a positive effect on breast cancer screening belief and behavior, and increase their awareness and knowledge level on this subject. In the long term, widespread effects such as reducing the costs women spend on breast cancer, reducing mortality and morbidity rates, raising a conscious society, training undergraduate students involved in the project, and helping them learn by experiencing the research conducted at the national level are foreseen.

Breast cancer is a disease that occurs with the uncontrolled proliferation of cells surrounding the milk glands and ducts in the breast. According to the 2020 data of the International Agency for Research on Cancer (IARC) Global Cancer Obsevartory (GLOBOCAN); The most common type of cancer among women worldwide is breast cancer. At the same time, breast cancer ranks second among deaths of known cause (IARCH, 2020). Similarly, according to 2019 data from the Health Statistics Yearbook, breast cancer ranks first among the most common cancer types among women in Turkey, and ranks second among deaths of known cause.

Early diagnosis in breast cancer is of great importance in increasing the survival rate and increasing the success of treatment. The fact that risk factors are effective in 20% of breast cancer cases and that most of these factors are unchangeable risk factors increases the importance of early diagnosis. Thanks to breast cancer screening methods, it is the first priority to catch breast cancer at an early stage before the clinical signs of breast cancer manifest itself and to reduce mortality rates. Early detection screenings such as Breast Self Examination (BSE), Clinical Breast Examination (CBE), and mammography are thought to be a way to increase early detection and decrease mortality rates.. According to the Turkish National Breast Cancer screening criteria, women older than 20 should periodically perform BSE every month; It is stated that women in the 20-40 age group should have CBE once every two years and women in the 40-69 age group should have CBE once a year. It is also recommended that all women between the ages of 40-69 have a mammogram every two years.

In detecting cancer at an early stage, it is extremely important to have information about the symptoms of cancer and to transform this information into behavior and observe in terms of symptoms. It is suggested that preventive behaviors such as a healthy lifestyle and health screening are beneficial methods in the prevention of breast cancer. In the literature, it has been determined that the knowledge level of women about cancer is not sufficient and they do not participate in breast cancer screening programs at the desired level and periodically.

Studies have also reported that women's attitudes towards breast cancer prevention behaviors and their level of knowledge are related to health literacy. Health literacy is extremely important for the health and health services of the general population because of its consequences that affect individuals and public health. Health literacy level, which is one of the factors that shape women's health, is effective in improving and managing women's health, and understanding and using the necessary information about women's health also increases the behavior of providing early diagnosis against diseases.. A high level of health literacy plays an important role in the protection of public health, as it constitutes an integral part of preventive health services as well as increasing the quality of life and eliminating inequalities. Considering the results of a study conducted in our country; It has been found that 68.9% of the individuals forming the society have insufficient or problematic-limited, 23.4% sufficient and 7.7% excellent health literacy level. Since individuals with low health literacy levels have difficulty in making the right decision about their health, their attitudes and behaviors towards cancer screening are more inadequate. In a study conducted in Turkey, it was concluded that women with limited health literacy had a low level of breast cancer knowledge, and that the low level of economic status and education also affected this situation. For this reason, low health literacy is considered as an important issue in terms of improving individuals' breast cancer knowledge levels and attitudes and behaviors towards screening. In a study, it was concluded that not performing BSE and not having mammography were associated with low health literacy levels. In another study, it is reported that the rate of women not having a mammogram is 52.2% and those who do not have a mammogram have a lower level of health literacy compared to women who have had a mammogram at least once.

As can be seen from the results of the study, the lack of knowledge of women on breast cancer and health literacy poses a major obstacle to people's breast cancer screening behaviors and beliefs. In order to increase social sensitivity and awareness on this issue; In particular, it is important to research, examine and examine how the municipalities and their employees, who are representatives of the society, evaluate breast cancer screening studies. From this point of view, we aimed to evaluate the effect of breast cancer screening training given to women working in the municipality on health literacy, breast cancer screening belief and behavior in our project.

With this training, awareness of women working in the municipality about breast cancer will be raised and it will be contributed to the municipalities, which are representatives of the society, to take steps to make programs that can reach a wider population. In addition, it is thought that this study will contribute to studies evaluating the effect of breast cancer screening education, which is limited in the literature, on health literacy, breast cancer screening belief and behavior.

Breast cancer is the second most common cause of death in our country and in the world. Early diagnosis in breast cancer is of great importance in increasing the survival rate and increasing the success of treatment. Studies have shown that women's knowledge about cancer is not at a sufficient level, they do not participate in breast cancer screening programs at the desired level and periodically, and their health literacy level is insufficient. The reason for this inadequacy is the lack of information. Many educational programs on breast cancer are organized. However, these programs are usually daily or weekly and are limited to increasing the level of knowledge. Breast cancer screening training cannot turn into behavior. With this study, the participants will be monitored for at least 6 months, and an effective fight against breast cancer will be taken. With the study, the knowledge and awareness of the employees working in municipalities, which are representative of the society, will be created through training and education on breast cancer screening. The results of our study will contribute to public health and to reduce health costs by preventing breast cancer with early diagnosis, with the increase in breast cancer screening rates in the long term. Nurses who play a leading role in public health and we, nurse candidates, will contribute to take steps in making programs that can reach a wider population in this regard.

The Effect of Breast Cancer Screening Training

The Effect of Breast Cancer Screening Training Given to Municipal Women on Health Literacy, Breast Cancer Screening Beliefs and Behaviors

It includes demographic information such as age, education level, income level, occupation, and duration of employment. In addition, it includes questions about whether they have sufficient information about breast cancer screening, whether they have received education, smoking status, and whether they have a chronic disease.

It is a five-point Likert scale containing 25 items. There is a positive relationship between the total score obtained from the scale and health literacy, and as the score obtained from the scale increases, the health literacy level of individuals also increases. It consists of four sub-dimensions. The first sub-dimension, Access to Information, consists of five items (1-5). The Comprehension of Information sub-dimension consists of seven items (items 6-12). The Evaluation/Evaluation sub-dimension consists of eight items (items 13 to 20). The Application/Using sub-dimension includes five items (items 21-25). The minimum score that can be obtained from the scale is 25; The maximum is 125 points.

The scale consists of 13 items. The scale consists of three sub-dimensions. Attitude towards health screenings sub-dimension items 1, 2, 3 and 4, breast cancer knowledge and perceptions sub-dimension items 5, 6, 7 and 8, and obstacles for mammography screenings sub-dimension 9, 10, 11, 12 and 13 consists of substances.The lowest score obtained from the scale is 0, and the highest score is 100. The fact that the mean score of the sub-dimensions of the scale is 65 and above indicates that screening beliefs have increased positively, their level of knowledge has increased and the barriers to mammography screening have decreased.

Istanbul Aydın University

Principal Investigator

150 Women without breast cancer, aged from 25 to 50 years old

6 months Web-App intervention related with: diet, physical activity, self-care and breast cacner risk prevention

Precam

Ruben Martin Payo, PhD

Aim: To evaluate the viability of an educational intervention for the prevention of breast cancer risk and the modification of their risk behaviors through the use of a web application in women living in the Principality of Asturias.

Design: pilot test Population: 300 women without breast cancer living in Asturias. 25 to 50 years old. Informed consent signed.

Variables: personal characteristics (age, status, educational level, occupation), MIC index, dietary characteristics, level of physical activity, presence of known risks of breast cancer (number of children, breastfeeding, oral contraceptives, family history of cancer, previous cancer, breast density and knowledge related with breast cancer prevention.

Intervention:

* Intervention Group:6 months intervention using a web-app related with personal care and breast cancer risks, diet and physical activity.
* Control Group: no intervention.

Aim: To evaluate the viability of an educational intervention for the prevention of breast cancer risk and the modification of their risk behaviors through the use of a web application in women living in the Principality of Asturias.

Design: pilot test Population: 300 women without breast cancer living in Asturias. 25 to 50 years old. They are recluted for a previous study developed by the same research team. An information document and a written consent was given for the women. Those who signed the consent are included.

The randomization for intervention or control group are doing based on the where the city where the women home is located. the objective of this distribution is to avoid contact between women from different groups.

Variables: personal characteristics (age, status, educational level, civil status), MIC index, dietary characteristics, level of physical activity, knowledge related with breast cancer symptoms and risk factors.

Intervention:

The 6 months intervention are going to be developed using a web-app. The intervention is based on the Behavior Change Wheel model. Capacity and motivation are going to be the determinants on which it will work using for it interventions based on education, persuasion and modeling among others.

Intervention Group: 6 months intervention using a web-app related. The web-app includes some sections:

* Information related with breast cancer risk.
* Breast self examination. Written text and videos done by a nurse.
* Physical exercise. Written text and videos done by a physiotherapist .
* Dietary information. Written text and videos done by a nutrition expert.

The Control Group are not going to receive intervention during the study period time. After that, women are going to be access to the web-app.

Statistical analysis

Descriptive statistics will be carried out (means, standard deviation, CI and percentages). In addition, at the end of the study, in order to determine the factibility of the educational intervention, the variation of the intra-group data (from pre to psot-test) and between the groups in post-test will be compared using the chi-square test. , t-student or Mann-Whitney U, for qualitative or quantitative data respectively.

Breast Cancer: Feasibility of an Educational Intervention

Feasibility of an Educational Intervention for the Prevention of Breast Cancer by Modifying Risk Behaviors Through a Web Application

Anonymizes data are going to be published but we are not going to analizase individual data.

Participants that finish the intervention

People that did not finish the intervention

Mean number of recommendations done by the participants

Using 2 dimensions of MARA questionnaire (Scale title)1) knowledge of risk factors of breast cancer (range 0=worst score to 9=better score); 2) knowledge of signs and symptoms of breast cancer (range 0=worst score to 9=better score)

University of Oviedo

Adverse Events were not monitored/assesed

Intervention Group

Control Group

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Spain

Region of Enrollment

Studies

Civil status

Vicerrectorado de investigación

Feasibility of an Educational Intervention: Adherence to the Intervention

Intervention

Control

Feasibility of an Educational Intervention: Drop Out After the Intervention Period

150 Women without breast cancer, aged from 25 to 50 years old

Precam: 6 months Web-App intervention related with: diet, physical activity, self-care and breast cacner risk prevention

Number of Diet and Activity Recommendations

Risk factors knowledge

Symptoms knowledge

Breast Cancer Awareness

Precam Group (Intervention Group)

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Premature Birth

Primary Ovarian Insufficiency

Menopause, Premature

Pregnancy Complications

Urogenital Diseases

Female Urogenital Diseases

Female Urogenital Diseases and Pregnancy Complications

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Gonadal Disorders

Endocrine System Diseases

Menopause

Pharmaceutical Solutions

All Drugs and Chemicals

Immediately following consent, participants randomized to the EMBRACE Group will begin with the EMBRACE intervention. Participants will meet with a registered nurse certified in sexuality and sex education once weekly for 8 - 10 weeks depending on scheduling. Each of the 8 sessions will last between 60 - 90 minutes. Participants will complete baseline measures, immediately following the intervention, and six weeks after the last session. Participants will be compensated for their time with a total up to $150.

After consenting, participants randomized to the Delayed EMBRACE Group will begin with the EMBRACE intervention 8 weeks after enrollment. Participants will meet with a registered nurse certified in sexuality and sex education once weekly for 8 - 10 weeks depending on scheduling. Each of the 8 sessions will last between 60 - 90 minutes. Participants will complete baseline measures, immediately following the intervention, and six weeks after the last session. Participants will be compensated for their time with a total up to $150.

The intervention will be led by a registered nurse who holds certifications in sexuality counseling and sex education. The therapeutic, online environment will serve as a confidential, private space without judgement to encourage discussion to model safe sexuality communication for breast cancer survivors. The curriculum will include: i) psychoeducation: sexual body, mind-body connection, and sexual relationships; ii) physical-body education: physical response, safety, and navigating physical changes in survivorship; iii) solution-focused tools: tailored vaginal rehydration, lubrication, education; and iv) communication: internal, partnered, and patient-provider communication skills.

EMBRACE (Empowerment through Mind and Body Reclamation After Cancer Experience)

Pearman D Parker, PhD, MPH, RN

The goal of this clinical trial is to test the efficacy of a nurse-led psychoeducational sexual health intervention for young women breast cancer survivors. The main questions it aims to answer are:

1. What is the feasibility of this intervention in an online, private setting?
2. What is the effect of this intervention on reducing menopausal symptoms, improving sexual functioning, and enhancing body image?

Participants will participate in a nurse-led psychoeducational intervention for 8 sessions lasting approximately an hour each over the course of 8 - 10 weeks. Each participant will complete survey items at the beginning, end, and six-weeks after the last session. Participants will be compensated up to $150 in gift cards as a thank-you for their time.

Participant eligibility is based on gender at birth.

Nurse-led Mind-body Intervention on Sexual Health for Breast Cancer Survivors

Impact of a Nurse-led Mind-body Intervention on Sexual Health for Young Women

A 21-item survey designed to measure vaginal symptoms, emotions, life impact due to vulvovaginal symptoms, and sexual impact of vulvovaginal symptoms. The scores range from 0 - 20 with the higher score meaning greater impact from vulvovaginal symptoms.

A 10-item survey designed to measure body image changes after cancer treatment. Scores range from 0 - 30 with the higher scores representing more body image disturbances related to cancer treatment.

A 19-item survey measuring female sexual functioning. Scores range from 2 - 36 with the higher score representing greater sexual function.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Clinical Investigation to Evaluate Microwave Imaging Via MammoWave® in a Population-based Screening Program for Early Breast Cancer Detection	NCT06291896	Women's Health:...	MammoWave	45 Years - 74 Years	Umbria Bioengineering Technologies
The Effect of Breast Cancer Screening Training	NCT05723237	Women's Health:...	Breast Cancer E...	18 Years -	Istanbul Aydın University
Breast Cancer: Feasibility of an Educational Intervention	NCT04396665	Women's Health:...	Precam	25 Years - 50 Years	University of Oviedo
A Clinical Investigation to Evaluate Microwave Imaging Via MammoWave® in a Population-based Screening Program for Early Breast Cancer Detection	NCT06291896	Women's Health:...	MammoWave	45 Years - 74 Years	Umbria Bioengineering Technologies
Nurse-led Mind-body Intervention on Sexual Health for Breast Cancer Survivors	NCT06307470	Women's Health:... Menopause, Prem... Body Image Sexual Dysfunct... Cancer, Breast	EMBRACE (Empowe...	18 Years - 50 Years	University of Arkansas
Nurse-led Mind-body Intervention on Sexual Health for Breast Cancer Survivors	NCT06307470	Women's Health:... Menopause, Prem... Body Image Sexual Dysfunct... Cancer, Breast	EMBRACE (Empowe...	18 Years - 50 Years	University of Arkansas

Spots Global Cancer Trial Database for women's health: neoplasm of breast