Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All 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

Women in the mHealth group will receive text and voice messages, in addition to their habitual care from the health clinic they attend. The messages will remind them to schedule a PAP smear, and will be sent for 1 year following enrollment in the study.

Women in the No mHealth group will not receive any text messages, and will only receive their habitual care from the health clinic they attend.

Text and voice messages sent to study participants reminding them to schedule a PAP smear.

mHealth

Javiera Martínez, MD, MPH

Francis Ciampi, Nurse

Javiera Martinez-Gutierrez, MD, MPH

Carmen Huerta

The purpose of this study is to evaluate the implementation and effectiveness of text messages as a means for improving adherence to cervical cancer screening.

1. Problem Outline, Theoretical Framework and Project Justification

   The problem: Cervical Cancer

   Cervical cancer is a serious public health problem. Worldwide, it is the third leading cause of death of women. An estimated 270,000 women die every year due to cervical cancer, and more than 85% of these deaths take place in developing countries (1).

   Chile´s national cervical cancer program was created in 1987. Since then, and with the systematic implementation of cervical cancer screening through Papanicolau (Pap) smears, cervical cancer mortality rates have dropped significantly (2,3).

   In spite of all efforts, cervical cancer continues to cause the mortality of more than 500 women each year in Chile. Across the nation, only 59 percent of the population is up-to-date with their Pap, a figure that has not changed significantly in the last 10 years (2). In the Metropolitan Region, this percentage is as low as 56 percent. The distribution of cervical cancer, like that of other cancers, follows a pattern of inequality in that women of lowest socioeconomic status are those most affected (4).

   Closing the Gap: Mobile Health (mHealth)

   Mobile technologies have had an exponential increase in the last few years.

   In 2014, the penetration of mobile phones will reach 90% in developing countries compared to 121% in developed countries. (5, 6).

   This same trend can also be seen in access to mobile broadband technologies, which will have an estimated penetration of 32% by the end of 2014.

   The number of internet users worldwide follows this same trend as well. By the end of 2014, there will be more than 3 billion users, with more than 2/3 of these in developing countries.

   According to a survey by the Deputy Minister of Telecommunications in Chile (7), access to a mobile or fixed internet connection was 39.4% by the end of 2009. This increased to over 60% by 2012.

   This coverage is distributed unequally according to socioeconomic class, with more than 81% of penetration in richer homes and less than 30% in poorer strata (21.4% and 9.8% respectively).

   On the other hand, mobile telephones reached more than 90% of homes in 2009, of both rural and urban survey respondents interviewed by the Deputy Minister of Telecommunications. While inequalities remain in this area as well, they are much less profound than with other technologies: the mobile telephone can be found widely distributed in all socioeconomic levels, and varies between 97% in richer strata and 82.8% in poor SES (7).

   By the end of 2013, the percentage of mobile telephone subscribers per 100 inhabitants was almost 40% for mobile phones with a contract and more than 94% for phones with prepaid plans.

   The Solution: Using mobile health technology (mHealth)

   Mobile health (mHealth) has been defined by the WHO (World Health Organization) as "medical and public health practice supported by mobile devices, such as mobile phones, patient monitoring devices, personal digital assistants (PDAs), and other wireless devices" (9).

   Given the explosion of the use of these technologies in the world and particularly in developing countries, the potential for mobile health in health issues is huge.

   The overall interest in mobile health is widespread (11). According to the WHO´s report on mHealth in 2011 (9), mobile health strategies exist in at least 75% of the countries that belong to the WHO in each region. 100% of the countries in the Southeast Asian region reported some mobile health initiative at different stages of development, and the Americas region reported that more than 90% of its countries had some form of mobile health initiative (Chile was not included in these statistics).

   According to the World Bank, high-income countries reported more initiatives than low-income countries.

   Some examples of mobile health initiatives in Latin America are the following: Mexico reported a mobile health program called MedicalHome in which a million mobile telephone subscribers have access to health professional support by telephone for $5 per month, which is charged directly to the cell phone account. Columbia reported a program for treatment adherence reminders using voice messages and Peru reported a RCT (Randomized Controlled Trial) that was done to assess treatment adherence using text messaging in patients with HIV/AIDS (9).

   One of the most relevant problems regarding the use of these technologies is that there isn´t sufficient evidence of its effectiveness in prevention (12). Because of this, it is imperative to invest in rigorous and systematic evaluations of these interventions so that they can be applied at the population level.

   While some evidence exists that shows that mobile health is an effective strategy for treatment adherence for prenatal care and those with HIV and TB (13,14,15), the potential use of mobile health technologies in cancer prevention has not been fully explored. Given the widespread existence of mobile telephones in Chile, investigators intend with this study to deliver a simple, replicable, and scalable intervention to improve the rates of morbidity and mortality due to cervical cancer that afflict Chile´s population.
2. Research Questions

1. Do mobile technologies have a preventive benefit in women with greater risk of getting cervical cancer as compared to usual care? 2. In women with greater risk of getting cervical cancer, what are the barriers and facilitators to implementing this kind of technological intervention?

3. Research Hypotheses

1. Null Hypothesis: The proposed intervention does not increase Pap adherence rates in the studied health centers.

   Alternative Hypothesis: The proposed intervention increases Pap adherence rates in the studied health centers.
2. Null Hypothesis: An intervention using mobile technology cannot be feasibly implemented in this population.

Alternative Hypothesis: It is possible to implement an intervention using mobile technology in this population.

4. Study Objectives General Objective: Evaluate the implementation and effectiveness of a mobile health intervention to increase cervical cancer screening adherence.

Specific Objectives:

1. Evaluate the effect that a text message intervention has on Pap adherence rates.
2. Evaluate the implementation and usability of a cellphone mobile health intervention in three health centers of the Southeast Metropolitan Health District of Santiago.

5. Methodology Design:

1. Quantitative phase:

   1. Target Population:

      Target population will be women between 25 and 64 years of age who use cell phones and do not have an up-to-date Pap test (no Pap in the last three years). They must also be registered at one of the following health clinics: CESFAM (Centro de Salud Familiar) El Roble or CESFAM Juan Pablo II.

      A randomized controlled trial will be carried out to evaluate the effectiveness of text message intervention in improving Pap adherence. Socio-demographic variables associated with its effectiveness will also be analyzed.

      Selection methodology: Using the database of medical records in each clinic, women will be identified that meet the inclusion criteria. They will be invited to participate in the study, and if they choose to accept, informed consent will be obtained.

      Before randomization, the participants will be asked to complete a questionnaire with simple demographic questions and questions regarding their beliefs and attitudes about cellphone use and cervical cancer.
   2. Randomization:

   Participants will be randomized into either the intervention group or the control group using a randomization software that keeps the randomization sequence hidden. The control group will receive their usual care in each health center, which consists of different interventions depending on the health center they attend. Examples of usual care include periodic midwife visits, education by health personnel and cervical cancer health campaigns.

   c) Intervention: Women randomized to the intervention group will receive text and voice messages (designed with input from previous qualitative phase) sent to their cellphones that remind them to get a Pap smear, send them information about cervical cancer, and inform them of health clinic location and hours where they could get a Pap smear.
2. Qualitative phase:

The implementation of a mHealth intervention could fail for many reasons. Some of the previously described barriers for this and other types of mobile interventions are: restrictions in the number of characters in the text message, illiteracy, poor signal coverage and quality, and confidentiality and pertinence in families where cellphones are shared.

However, there may be many other factors that hinder or facilitate its effectiveness: lack of funds to keep credit on a cellphone throughout the entire month, losing the phone, little use of text messaging in the elderly, among others.

Investigators will carry out focus groups with women who receive care at the participating centers in order to define barriers and facilitators to a text message intervention that will promote Pap adherence.

Focus Groups Participants:

Women between 25 and 64 years old that meet the inclusion criteria for the study.

Midwives at the health care centers.

Investigators will carry out nine (9) focus groups in total. Women will let us know about barriers and facilitators to the use of this technology and midwives will help investigators to characterize the usual care that women receive and better inform text message content as well as barriers to their use.

Every community member that attends a focus group will receive an incentive of 5,000 Chilean pesos (8 USD) for their time and information. Each health professional that attends a focus group will receive 10,000 Chilean pesos (16 USD).

Data Encoding The focus groups will be led by individuals expert in qualitative methods and assisted by the Principal Investigator and a student assistant who will serve as a note-taker. The focus groups will be recorded for analysis.

The audio of the focus groups will be transcribed and coded using the software Atlas.ti version 6.2

Analysis Information will be analyzed using a qualitative content analysis process\* by two or more investigators who will extract relevant themes regarding usage patterns, barriers, and facilitators to this type of intervention. Investigators will use the conceptual framework called PRECEDE-PROCEED in order to carry out the analysis\*. Investigators will use it to identify predisposing factors that reinforce and enable the use of mobile technologies to improve Pap adherence.

The collected information will contribute to the design of the intervention, and from there the quantitative phase of the study will begin.

d) Sample size Previous studies have shown that without an intervention, around 30% of women who are not up-to-date with their Pap test will get a Pap within the following 6-12 months. Looking at literature regarding similar interventions for other pathologies, investigators anticipate seeing an absolute increase of 15% in adherence rate. With this difference in proportions, and alpha errors of 5% and beta errors of 20%, the estimated sample size is 176 per arm. Considering a loss of 10%, investigators will recruit an estimated 200 patients per arm.

e) Statistical Analysis Investigators will use descriptive statistics to characterize demographic variables of the included patients in the same manner as charactering the indicators of implementation.

For the primary outcome (proportion of women with an up-to-date Pap), investigators will use a chi-squared test to test differences in proportions.

For the multivariate analysis, investigators will use logistic regression and Poisson regression.

For the categorical variables, investigators will use a chi-squared test.

Messages For Your Health: A Cancer Screening Prevention Study

Development of Mobile Technologies for the Prevention of Cervical Cancer in Santiago, Chile: A Randomized Controlled Trial.

The information will be collected from the cancer registration and monitoring database (CITOEXPERT/REVICAN), where Pap data of the population at the national level is registered. Investigators will also review medical records from participating patients at the two health centers. The data collection will take place 6 months after initial recruitment.

Centro de Salud Familiar El Roble

Pontificia Universidad Catolica de Chile

Javiera Martínez MD, MPH

This study was carried out with two groups. Technology Based Motivation Program were used for the intervention group.

No application was made to the control group, standard procedure was followed.

A 10-week "Technology Based Motivation Program" was given to the intervention group. The website and four training modules were used with the children in the intervention group. Nine coaching interviews with each child (once a week) were conducted over WhatsApp. The children were encouraged to do progressive relaxation and breathing exercises at least twice a week, and eight therapeutic stories (once a week) were sent to the child's phone in the form of animation.

Three training modules were used with the primary caregivers, and coaching interviews were conducted on WhatsApp twice during the program. Primary caregivers practiced progressive relaxation and breathing exercises at least twice a week. In addition, eight motivation messages were sent to the child and primary caregiver, and 24/7 consultancy was provided.

Technology Based Motivation Program

Zeynep Kisecik Şengül, RN, PhD

Purpose: To determine the effectiveness of the technology-based motivation program implemented with children with cancer diagnosis and their primary caregivers.

Methods: This randomized controlled trial was completed with 31 children and 31 primary caregivers between the ages of 9 and18, who were being treated for cancer. A 10-week "Technology Based Motivation Program" was given to the intervention group. "State/ Trait Anxiety Inventory for Children", "Paediatric Quality of Life Inventory", "Paediatric Cancer Coping Scale", "State and Trait Anxiety Inventory," and "Process Evaluation Forms" were administered. Chi-square test, Fisher-Exact test, Independent Sample-t test, Man-Whitney U test, Wilcoxon test, Pearson and Spearman correlation coefficients were used for data analysis.

Design The study was conducted in two hospitals at Leukemia Polyclinic, Paediatric Haematology and Oncology Polyclinic, and Paediatric Haematology-Oncology Service from September 2019 to August 2020.

Setting and Samples In determining the research population, hospital registry information was used, and 119 children followed up with a diagnosis of cancer formed the research population. The sample of the research consisted of 44 children (leukaemia n = 33, solid tumour n = 11) and their primary caregivers meeting the inclusion criteria.

Randomization and blinding A stratified randomization method was used in the research. 44 children (leukaemia and solid tumour) who met the inclusion criteria were grouped according to gender (male and female) and age (9-13 years-14-18 years) and eight layers were obtained. Among the identified strata, intervention and control groups were randomized by an independent statistician using the website www.randomizer.org, 22 children were assigned to the intervention, and 22 to the control group. Five children from the intervention group and five children from the control group (unreachable (n=3), ex (n=1), refusal (n=4), Hematopoietic stem cell transplantation (HSCT) performed (n=1), intensive care unit admission (n=1)) could not be included in the research for various reasons and 34 children were included in the research. The purpose and content of the research were explained without informing the children and their primary caregivers that they were in the intervention or control group.

At the end of the research, the power analysis performed by using the mean scores of State Anxiety Inventory for Children with G \* Power 3.0.10 program yielded a total of at least 28 samples that were found to be sufficient with 90% power and 5% margin of error (n1 = 14; n2 = 14).

Theoretical underpinnings The use of models is important in establishing the theoretical framework of research. In this research, the Transactional Stress and Coping Model of Lazarus and Folkman, which is the most widely used model in studies examining the coping and anxiety levels of children with cancer diagnosis, was used. The practices in the motivation program were created for the coping strategies of "seeking social support, self-control, positive evaluation and accepting responsibility" in the model.

Interventions The research consists of four stages. (1) Constructing training modules, (2) Creating a website, (3) Conducting preliminary intervention, and (4) Implementing the training modules with the children and primary caregivers in the intervention group.

Constructing training modules Four training modules for children and three training modules for primary caregivers were created by the researchers in line with the literature Content was added to the website after it was approved by 6 experts.

Creating the website The website was designed by a professional web design firm. The website can be accessed by computer, tablet and phone. There is an administrator and user panel on the website. Children and primary caregivers logged on the website with different passwords through the user panel and accessed the modules specially prepared for them.

Conducting preliminary intervention The preliminary intervention of the technology-based program was conducted with five children aged 9-18 years who were followed up with a diagnosis of leukaemia, and with their primary caregivers. As the child and primary caregivers found the program applicable as a result of the preliminary intervention, no change was made and it was included in the sample.

Using the training modules with children and primary caregivers in the intervention group The website and four training modules were used with the children in the intervention group. Nine coaching interviews with each child (once a week) were conducted over WhatsApp. The children were encouraged to do progressive relaxation and breathing exercises at least twice a week, and eight therapeutic stories (once a week) were sent to the child's phone in the form of animation.

Three training modules were used with the primary caregivers, and coaching interviews were conducted on WhatsApp twice during the program. Primary caregivers practiced progressive relaxation and breathing exercises at least twice a week. In addition, eight motivation messages were sent to the child and primary caregiver, and 24/7 consultancy was provided.

Control Group The routine practices of the children in the control group and their primary caregivers at the hospital continued. In addition, forms other than process evaluation were given to the child and their primary caregivers at the beginning and end of the program.

Data gathering After the children and primary caregivers who participated in the research were informed about the research in an empty room or in the room where they were treated during the polyclinic controls, data collection forms were given, the children and primary caregivers in the intervention group were subscribed to the website, and the exercises were explained in practice. It took approximately 60 minutes for the participants to fill out the forms and learn about the program. At the end of the research, the data collection forms (excluding the descriptive data form) were collected through WhatsApp messages.

Data collection tools Child and Parent Descriptive Characteristics Form, Spielberger State-Trait Anxiety Inventory, State/ Trait Anxiety Inventory for Children, Paediatric Cancer Coping Scale, Paediatric Quality of Life Inventory, and Process Evaluation Forms were used to collect the data.

Ethical considerations Permission for the research was obtained from the University Ethics Committee and Hospitals. Informed written consent was obtained from the children and their primary caregivers, who agreed to participate in the research, after written and verbal explanations were given to the patients to participate in the research. At the end of the study, all interventions were also performed with the control group.

Among the identified strata, intervention and control groups were randomized by an independent statistician using the website www.randomizer.org. The data of the study were entered by a person other than the researcher. Statistical analysis was performed by a person other than the researcher.

Motivation Program for Children With Cancer

Investigation Into the Impact of Technology-Based Motivation Program Applied to the Children Followed With Cancer Diagnosis and Their Families: A Randomized Controlled Study

The confidentiality of the data used in the study will be protected.

State/ Trait Anxiety Inventory for Children: 20 items for the State Anxiety, 20 items for the Trait Anxiety. The scores on the scale range from 20 to 60, and a high score indicates high anxiety.

Pediatric Quality of Life Inventory: The scale consists of 23 items and is scored from 0 to 100. The higher the score, the higher the quality of life

Pediatric Cancer Coping Scale:The scale comprises 33 items related to cognitive coping, problem oriented coping, and defensive coping.The score obtained from the scale ranges from 0 to 99. Higher scores on the scale indicate a high level of coping strategies.

Spielberger State/ Trait Anxiety Inventory: 20 items of the 40-item scale are used to determine state anxiety and 20 items are used to determine trait anxiety.The scores on the scale range from 20 to 80, and the higher the score, the higher the level of anxiety.

Process evaluation forms:Six forms were prepared by the researchers. It was used to follow the practices and interviews of children and primary caregivers. 1. Website training follow-up form, 2. Mobile video interview follow-up form, 3. Counseling follow-up form, 4. Children's follow-up form for interventions, 5. Primary caregivers follow-up form for interventions, 6. Satisfaction and suggestion form

Zeynep Kisecik Şengül

Assistant Professor

Patients in the intervention group will be part of a renewed care pathway supported by digital tools.

Patients in the control group will receive standard of care, specific to the hospital where the patient is being treated.

In the intervention group, the renewed, patient-centred care pathway will be coordinated by the Advanced Practice Nurse (APN) and will be supported by digital technology. The intervention aims to increase the involvement of the patient in the treatment decision process, to provide comprehensive care through the quarterly meeting of all professionals involved in the care of the patient during a Health Professional Consortium (HPC) and to support patient empowerment by supporting self-management by using digital tools.

Health Professional Consortium

Holis Dashboard - Holis Patient App

Hans Wildiers, prof. dr.

Cindy Kenis, PhD

The GerOnTe TWOBE study aims to evaluate the effectiveness of the GerOnTe intervention, consisting of a renewed, patient-centred, care pathway coordinated by an APN and supported by a Health Professional Consortium and IC Technology, compared to the current standard of care in the eight different Belgian and Dutch hospitals.

The GerOnTe TWOBE study aims to evaluate the effectiveness of the GerOnTe intervention, consisting of a renewed, patient-centred, care pathway coordinated by an APN and supported by a Health Professional Consortium and IC Technology, compared to the current standard of care in the eight different Belgian and Dutch hospitals. The GerOnTe project consists of two identical trials in two different European geographical areas, FRONE in France and TWOBE in Belgium and the Netherlands. The goal of two identical trials is to take into account the role of health care contexts in the implementation, effectiveness and efficiency of the GerOnTe intervention. A stepped wedge randomized controlled trial, where the randomized clusters will be participating hospitals, will be conducted in eight academic and general hospitals in total with a follow-up at 3, 6, 9 and 12 months after study inclusion. Patients will be recruited in all participating hospitals in the period between the cancer diagnosis and the treatment decision.

stepped wedge randomized controlled trial (cross-over type)

Geriatric and Oncological Evaluation With Technology for Holistic Healthcare Management for Older Multimorbid Patients.

Streamlined Geriatric and Oncological Evaluation Based on IC Technology for Holistic Patient-oriented Healthcare Management for Older Multimorbid Patients. TWOBE Study

Quality of Life assessed by the EORTC QLQ-C30 (version 3.0) questionnaire. HRQOL evaluation was performed using the European Organization for Research and Treatment Quality of Life Questionnaire core 30 (EORTC QLQ-C30) Global Health Status Scale (GHS).

Three derived scores of the QLQ-C30 questionnaire are considered as primary endpoints:

* Normalized global health status score of the QLQ-C30 (version 3.0) (score 0-100),
* Normalized score of the physical functioning scale of the QLQ-C30 (version 3.0) (score 0-100),
* Normalized score of the emotional functioning scale of the QLQ-C30 (version 3.0) (score 0-100).

A high score for a functional scale represents a high / healthy level of functioning.

A high score for the global health status / QoL represents a high QoL.

HRQOL evaluation was performed using EORTC QLQ-C30 Global Health Status Scale (GHS) and Quality of Life Questionnaire Elderly Cander Patients 14 (EORTC QLQ-ELD14) Global Health Status Scale (GHS).

* Normalized scores of global health status, physical functioning scale and emotional functioning scale of the QLQ-C30 (version 3.0) (score 0-100).
* Normalized scores of the QLQ-C30 symptom scales/items (score 0-100).
* Scores of QLQ-ELD14 scales/items (score 0-100).

A high score for the global health status / QoL in QLQ-C30 represents a high QoL.

A high score for a symptom scale / item represents a high level of symptomatology / problems.

High scores in QLQ-ELD14 indicate poor mobility, good family support, much worry about the future, good maintenance of autonomy and purpose, and high burden of illness.

Survival as the length of time from the start of treatment and death from any cause.

Progression-free survival (PFS) defined as the time from study treatment initiation to the first occurrence of disease progression or death (of any cause), whichever occurs first.

Dependence score measured by Activities of Daily Living (ADL). The ADL scale includes six items (bathing, dressing, toileting, transferring, continence and feeding), with a score for each item scores ranging from one (able to perform the activity) to four (unable to perform the activity) (range: 6-24).

Proportion of patients living at home (range: 0-100%). The higher the percentage, the more patients live at home.

Number of completed chair stands in 30 seconds measured by the Chair Stand Test. Participants stand up repeatedly from a chair for 30 seconds.

The overall level of fitness or frailty of the older patients will be assessed by the 9-point Clinical Frailty Scale (CFS) (score: 1-9).

The higher the score, the less fit or more frail the older person is.

The ECOG Performance Status Scale (ECOG-PS) describes a patient's level of functioning in terms of their ability to care for themself, daily and physical ability (score: 0-5).

The higher the score, the less active the older person is.

The weight of a person (in kilograms) measured with a scale.

Patient anxiety measured by the Hospital Anxiety and Depression Scale (HADS). The 14 questions can be answered by a 4-point Likert scale (0-3). The odd questions (1, 3, 5, 7, 9, 11, 13) refer to fear (score: 0-21).

The higher a person scores on this questionnaire, the more complaints of anxiety he/she experiences.

Proportion of patients institutionalised (see definition) (range: 0-100%). Definition: Institutionalisation means that a patient moves permanently to an institution among which are considered retirement houses.

Proportion of patients with at leas one unscheduled hospitalisation and number of unscheduled hospitalisations per patient (see definition) (range: 0-100%).

Definition: Unscheduled hospitalisation includes any hospitalisation which has not been previously planned because of an unscheduled event (severe adverse event, complication of treatment, decompensation of morbidity) whatever it is linked or not to the emergency room.

Life years gained (LYG) in the cost per life years gained (CEA) derived from a clinical metric (overall survival/progression-free survival).

Quality-adjusted life years (QALYs) in the cost per QALY gained (CUA) calculated using utility assessed through normalised scores of EQ-5D-5L questionnaire. It includes the 5-level questions covering five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This results in a 5-digit code for EQ-5D-5L, which reflects how good or bad a health state is according to the preferences of the general population of a country/region (score: 11111-55555 (or 99999 for missing data)).

Total amount resulting from all direct (medical or non-medical) and indirect costs related to disease and care, collected during the 12 months of patient follow-up.

Total burden of the caregiver in health, psychological well-being, finances, social life and relationship with the patient will be obtained using the Zarit Burden Interview (ZBI) by adding the scores across all 22 items. Each question is scored on a 5-point scale (score: 0-88).

The higher the score, the heavier the caregiver burden.

Patient experience of person-centred coordinated care measured through the Person-Centred Coordinated Care Experience Questionnaire (P3CEQ) - 11 items in 5 domains: information and communication processes, care planning, transitions, goals and outcomes and decision making.

Patient satisfaction and usability of mHealth application within the GerOnTe intervention will be evaluated by using the score derived from the 21-items mHealth App Usability Questionnaire (MAUQ) for standalone mHealth Apps (Patient version).

Physician and health-professional satisfaction and usability of mHealth application within the GerOnTe intervention will be evaluated by using the score derived from the adjusted version designed for health care providers of the mHealth App Usability Questionnaire (MAUQ) for standalone mHealth Apps (Provider version), consisted of 18 items.

Number of connections to the Holis Patient App.

Frequency of connections to the Holis Patient App.

Duration of logins and activities with the Holis Patient App,

Number of web-based meetings with Advanced Practice Nurse by site.

Number of Advance Practice Nurse (APN) consultations by site (and by patient).

Number of Patient Reported Outcome Measures (PROM's) dashboards completed by patient (Holis Patient App).

Number of health professional meetings (Multidisciplinary Tumour Boards (MTB) or other morbidities treatment decision) involving complete dashboards analysis by site.

University of Bordeaux

Diakonessenhuis, Utrecht

University of Milan

University College Dublin

Oslo University Hospital

International Society of Geriatric Oncology

Dublin City University

Universitair Ziekenhuis Brussel

General Hospital Groeninge

AZ Sint-Jan AV

Catharina Ziekenhuis Eindhoven

Reinier de Graaf Groep

KU Leuven

Universitaire Ziekenhuizen KU Leuven

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

The Idylla EGFR Mutation Test, performed on the BioCartis Idylla System, is an in vitro diagnostic test for the qualitative detection of exon mutations. One of the biggest challenges in oncology biomarker testing is the ability to obtain samples of sufficient size and quality. This study can help test the BioCartis Idylla System against standard of care (SoC) pathology results from tissue biopsies in the same setting, ultimately being able to diagnose with a fraction of the tissue previously needed.

This diagnostic test is performed on the BioCartis Idylla System for qualitative detection of exon mutations.

Idylla EGFR Mutation Test

Hannah Park, BS

So Hyeon Park, MS

Anthony Magliocco, MD

This retrospective, observational study will compare the results of a BioCartis' EGFR mutation test on the Idylla platform with test results from SoC pathology results from tissue biopsies in the same setting. A comparable rapid testing platform for EGFR may serve as a more accessible means to diagnose, and overall, more patients treated successfully with targeted therapies. Up to 150 samples will be tested and compared with existing results.

This study will compare the results of a BioCartis' EGFR mutation test on theIdylla platform with test results from standard of care (SoC) pathology results from tissue biopsies. The Idylla™ EGFR Mutation Test, performed on the BioCartis Idylla™ System, is an in vitro diagnostic test for the qualitative detection of exon 18, exon 20, and exon 21 mutations. Additionally, exon 19 deletions and exon 20 insertions in the EGFR oncogene. A rapid testing platform for EGFR may serve as a more accessible means to diagnose, and overall, more patients treated successfully with targeted therapies.

Idylla EGFR Lung Trial

Technology Study: Measuring Potential Impact of Research Use Only Rapid EGFR Testing on Standard of Care

The primary outcome measured is if the Idylla EGFR Mutation Test is a possible alternative to diagnose EGFR mutation status in tissue samples.

Anthony Magliocco

Principal Investigator

Symptoms and General Pathology

Neoplasm Metastasis

Pain

Neoplastic Processes

Observe the rates of pain control and the need to retreat patient, when applied to personalization of indications and maximum technological support for palliative radiotherapy to patients with \< 6 months prognostic score attendance

Personalization of palliative radiotherapy

Francesco Cellini, MD

Non-randomized, monocentric, observational study to evaluate the response in terms of reduction of painful symptoms from bone metastases to radiotherapy with high personalization of treatment: performed with modern technology, supplied with modulated intensity technique with concomitant integrated boost, according to selection of patients in accordance with prognosis determined by specific prognostic score

Palliative antalgic oncological treatments concern a chronically-evolving disease patient with pain control problems, and are a complex problem from different points of view: logistic, clinical and scientific research. An increasing number of patients are afflicted due to the increased incidence of cancer in all its phases and the potential chronicity of the disease linked to new therapies.

The use of palliative anti-radiation radiotherapy treatments involves up to 40% of patients in a Radiotherapy Center. Radiotherapy was used in the palliative treatment of symptomatic bone metastases to improve quality of life (QoL) of these patients. This is the easiest way to respond to problems of home care or long-term care (eg: Hospice). This need is particularly accentuated for patients with a more severe situation. To reduce the overall duration of the treatment, it is necessary to manage hypofractionated regulators (ie with dose fractionation which daily dispense a dose higher than 2Gy). In fact, hypofractionated regimes concern the gold standard for these clinical presentations.

With the same pain control, multiple fractionation boards report better symptom control over time and are therefore very often preferred for patients with a prognosis\> 6 months. On the other hand, the treatment regimen with 8 Gy in single therapy session is suggested as preferable for patients with a worse prognosis (ie less than 6 months of life expectancy). Evidence from literature suggests that palliative radiation therapy is effective in controlling pain even in the last weeks of the patient's life and therefore useful to improve the conditions of patients with a more severe prognosis.

The identification of patients with the worst prognosis to which single-agent radiotherapy is reserved is another crucial aspect. Unfortunately, although clinically validated in scientific trials, the routine use of prognostic scores is rarely used in everyday clinical practice to characterize life expectancy and define the most appropriate treatment regimen. This aspect limits the effective personalization of palliative treatments of this type.

Furthermore, the indications available in the literature do not specify a univocally shared standard of technical approach to radiant treatment. The Consensus Conference whose data have been reported by Chow et al. considers as potentially applicable both non-conformed techniques (e.g .: single back beam) and the most modern conformational techniques. The less conformed techniques have the defect of distributing in a more variable way the dose inside the target to irradiate and to save less well the organs at risk (OAR) with consequent increase of the risk of toxicity that could reduce the beneficial to the patient given by the reduction of pain from metastases.

Finally, the prescription of the single 8 Gy radiotherapy session in daily practice is still not sufficiently widespread, as evidenced by international literature . Due to the peculiar characteristics of the patients who need these treatments, scientific research aimed at optimizing these therapies is a need for assistance and even ethics.

This particular analysis, within the Umbrella Protocol, focuses on patients with uncomplicated and painful vertebral bone metastases, and is aimed at observing and recording the efficacy of treatment in a single 8 Gy session, applied in good clinical practice. according to available evidence.

Particular attention is paid to applying a high degree of personalization of the treatment and a modern approach to the technology of performing the radiant treatment. The personalization of the treatment will be favored by the routine use of: i) a valid prognostic score for the expected survival, the Mizumoto prognostic Score (Mizumoto M, 2008), to identify patients with the worst prognosis to offer treatment in a single session. The use of the most advanced radiation dose administration technologies will be applied by choosing (in the spectrum of technologies applicable to these clinical presentations) the most modern modulated intensity radiotherapy (IMRT). IMRT allows to reduce the dose administered to the OAR and to concentrate the areas with the highest dose concentration (the so-called "hot spots") only within the evidence of disease (or "Gross tumor Volume" - GTV). Through the integrated simultaneous boost (SIB) method in IMRT, it is possible, in fact, to check the extent and location of the "hot zones" by specifying, through precise prescription, the maximum desired amount and the topographic limits to the inside of the target prescribed at the dose of 8 Gy, however doing "drop" the dose to the surrounding OAR.

The hypothesis of the study is to observe the rates of pain control and the need to retract the patient, when applied to personalization of indications and maximum technological support. These results could be a basis of scientific evidence to further support the clinical orientation towards the use of the single fraction of radiotherapy with consequent improvement in the quality of life of these patients. Furthermore, such data will be able to feed further analyzes aimed at the cost / effectiveness of this approach.

Single frActIoN eighT Gray Palliative Radiotherapy With Modulated Intensity for Pain Reduction

SAINT: Single frActIoN eighT Gray Palliative Radiotherapy With Modulated Intensity for Pain Reduction: a Single Arm Cohort Analysis

Pain control measured with Numeric Rating Scale (NRS) score, a 11-point scale for patient self-reporting of pain.

NRS score presents a total range between 0 (no pain) and 10 maximum pain.

NRS subscale are the sequent:

* 0: no pain
* 1-3: mild pain
* 4-6: moderate pain
* 7-10 severe pain

To evaluate the possible correlation between the adequacy of antalgic treatment and potential predictors such as tumor type, purpose of treatment, care setting, stage of disease

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Carcinoma

Prostatic Neoplasms

Genital Neoplasms, Male

Genital Diseases, Male

Prostatic Diseases

Male Urogenital Diseases

Written Information Prescription Technology

Written Information Prescription Technology Coaching

Receive written information on diet and exercise relevant to older men with prostate cancer

Written Information

Participants receive tailored exercise prescription and tailored diet recommendations

Prescription

Participants receive motivational text messages and can electronically log and track their exercise and diet habits

Technology

Participants receive access to an exercise and diet coach to provide advice by phone and/or email

Coaching

Kerri Winters-Stone

This pilot clinical trial studies how well the True NTH Community of Wellness internet-based exercise and diet support works in improving diet and exercise habits in prostate cancer survivors. Internet-based exercise and diet support may help better control treatment-related side effects and symptoms, better overall quality of life, and lower risk factors associated with cancer progression.

PRIMARY OBJECTIVES:

I. To determine the feasibility and acceptability of the Community of Wellness web portal among prostate cancer survivors by conducting a randomized controlled study comparing four levels of web-based content and interaction with participants.

SECONDARY OBJECTIVES:

I. To compare efficacy of four levels of web-based content in the Community of Wellness web portal in a pilot randomized controlled trial on exercise and dietary habits, self-efficacy for behavior change, motivation for exercise, and changes in treatment-related side effects.

OUTLINE: Patients are assigned to 1 of 4 groups.

GROUP I: Patients receive "Written Information" which includes access to the TrueNTH open access portal that provides basic written information about exercise and diet.

GROUP II: Patients receive access to "Written Information + Prescription", including written information plus additional an exercise prescription and tailored diet recommendations.

GROUP III: Patients receive access to "Written Information + Prescription + Technology", including written information, exercise prescription + diet recommendation and additional technology components. Patients complete diet and exercise behavior logs and receive educational and motivational text messages about healthy diet and exercise habits.

GROUP IV: Patients receive access to "Written Information + Prescription + Technology + Coaching" and receive written information, exercise prescription + diet recommendation, technology support and a 30-minute (each) diet and exercise consultation plus the ability to receive ongoing advice from coaches via the web portal.

After completion of intervention, patients are followed up at 3 months.

Internet-Based Exercise and Diet Support in Prostate Cancer Survivors

True NTH Community of Wellness Internet-Based Exercise and Diet Support for Prostate Cancer Survivors

Measured as ability to recruit target sample size within one year

Measured as the % of men who complete post-intervention and follow-up measures out of the total # of men enrolled

Measured as the # of times that a man visits the portal over three months

CHAMPS estimates total weekly energy expenditure (in kilocalories per week) from low to vigorous intensity physical activities for older adults.

This 132-item survey assesses dietary intake over the past month in categories from "never or less than once per month" to "6 or more times per day" and supports examining major food and nutrient categories of the U.S. diet.

A 6-item measure of Self-efficacy for Exercise will be used. Summed scores range from 6-30, and higher scores indicate higher self-efficacy.

This 5-question measure asks the person to select one description, from a choice of five, which describes his current activity behavior.

The Charlson Comorbidity Index is a weighted index to predict mortality. Scores range from 0-37, with higher scores indicating more chronic medical conditions.

Diet self-efficacy will be measured by having participants rate their confidence in performing each recommended task (e.g., two more servings of cooked tomatoes per week) using a Likert scale.

This self-report questionnaire assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score.

MAX-PC is an 18 item scale to facilitate the identification and assessment of men with prostate cancer-related anxiety. This scale consists of three subscales that measure general prostate cancer anxiety, anxiety related to prostate specific antigen (PSA) levels in particular, and fear of recurrence.

PROMIS - Fatigue evaluates self-reported symptoms of fatigue, from mild subjective feelings of tiredness to an overwhelming sense of exhaustion over the past seven days.

BREQ2 measures the continuum of behavioral regulation in exercise psychology research. This questionnaire concerns the reasons why a person exercises regularly, works out, or engages in other such physical activities. It is structured so that it asks one question and provides responses that represent external regulation, introjected regulation, identified regulation, and intrinsic motivation.

EORTC QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients and has five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnea, loss of appetite, insomnia, constipation and diarrhea) and perceived financial impact of the disease. Scores range from 0-100, with higher functional scale scores indicating a higher level of healthy functioning while a higher score for a symptom scale represents a higher level of symptomatology or problems.

Movember Foundation

OHSU Knight Cancer Institute

Skin and Connective Tissue Diseases

Breast Neoplasms

Mobility Limitation

Technology allowing measurement of physical activity

Activity monitor

Richard M Kwasnicki, PhD MRCS

Daniel R Leff, PhD FRCS

Richard Kwasnicki

This work aims to use wearable sensors to record the return towards normal physical activity after breast surgery. It will build on current evidence by using objective measures of activity and arm movements rather than patient reports.

Breast: Recovery After Axillary Node Clearance - Evaluating Limbs With E-Technology (the BRACELET Study)

Arm movements as measured by wearable sensor

Imperial College London

Behaviors and Mental Disorders

Anxiety Disorders

Breast Diseases

Skin Diseases

Quality of Life

The mobile application will be downloaded on smart phones of participants. This group will be able to look up information related to surgical period when needed.

The control group will receive routine care. This group will wear smart band for pulse rate, sleep, blood pressure, and SpO2 record for data collection times.

The education will include information about surgical process and care after surgery.

digital technology-supported education

Aylin Günay, MSc,RN

Azize Karahan, Prof

The goal of this randomized, controlled study is to test the effectiveness of digital technology-supported education on patients undergoing breast reconstruction after mastectomy.

Breast cancer is the most common type of cancer in our country and all over the world, and there are surgery, radiotherapy, chemotherapy, hormonal and targeted treatment options in the treatment of patients diagnosed with breast cancer. Surgery is an important option for the majority of patients diagnosed with breast cancer, and breast-conserving surgery and mastectomy are frequently performed. Patients who undergo mastectomy can also choose breast reconstruction surgeries, which enable the reconstruction of breast tissue through various methods, because they feel better both psychologically and physiologically.

Breast reconstruction can be performed in two periods: early and late. Patients who undergo breast reconstruction simultaneously with mastectomy may experience psychological problems such as anxiety, depression and fear in the preoperative period, and patients may experience surgery-related bleeding, hematoma, seroma, wound infection, tissue necrosis, fat necrosis, capsule contraction, implant loss and pain. Complications may develop and individuals' quality of life may be negatively affected. Patients need support care, treatment and preventive health interventions, and education on late effects/long-term physical and psychosocial problems in order to maintain their independence in daily activities and improve their quality of life.

In addition to written, visual and audio materials in patient education, mobile applications and wearable technologies come to the fore with developing and advancing technology. Mobile health service offered starting from the pre-operative period; In addition to heart rate, blood pressure, oxygen saturation, blood glucose level, daily drainage monitoring, spirometry results and medication compliance; Pain level, sleep quality, daily living activities and exercise level can be evaluated, and the quality of care is increased with nursing care practices and continuity of education.

This study aims to determine the effect of mobile technology-supported education and monitoring on care outcomes in patients who underwent breast reconstruction simultaneously with mastectomy due to breast cancer.

A mobile application will be developed by software engineer including informational needs of breast cancer patients starting prior to surgery lasting to discharge. Expert opinion will be obtained about contents of mobile application. The application will be downloaded smart phones of patients for use when needed. Patients who meet the inclusion criteria will be informed about the research by the researcher according to the randomization list, and their consent will be obtained from those who agree to participate in the research. Due to the study design, patients will not know which intervention is being applied to them, and it will be done single-blinded. The application will be carried out by the researcher knowing the patients in the intervention and control groups. The analysis of the data coded as A and B will be done by a statistician.

Those who accepted the study were asked to read the "Informed Volunteer Consent Form" indicating that they volunteered to participate in the study, and the control and intervention group patients were instructed not to share information about the application with each other in order to prevent them from being influenced by each other in the outpatient clinic environment/institution.

The Effect of Digital Technology-Supported Education on Patients Undergoing Breast Reconstruction After Mastectomy: A Randomized Controlled Study

The Effect of Digital Technology-Supported Education and Monitoring on Anxiety, Pain, Sleep and Quality of Life in Patients Undergoing Immediate Breast Reconstruction After Mastectomy: A Randomized Controlled Study

The Hospital Anxiety and Depression Scale will be used. It is a valid and reliable scale in Turkish. The higher score the higher risk for depression or anxiety. (Change from baseline to 5th, 15th and 30th days will be assessed).

Visual Analogue Scale (VAS): It is used to evaluate the subjective discomfort states of patients. It consists of a horizontal line 10 cm long. It is a ruler with the left side stating "no pain" and the right side stating "the worst pain" (unbearable pain). Values range from 0 to 10, with higher values indicating increased discomfort. It is easy to apply. It has been shown to be sensitive to pain and discomfort.

Pittsburg Sleep Quality Index: It is valid and reliable scale. in Turkish language.The scale consists of 24 questions, 19 of which are feedback questions and 5 of which are to be answered by the spouse or roommate. When calculating the index score, questions answered by the individual's spouse or roommate are not included in the calculation. Self-assessment questions include various items related to sleep quality. These are to determine sleep duration, sleep latency, and the frequency and severity of specific sleep-related problems. The 18 items scored are grouped into 7 component scores. Some of the components consist of a single substance, while others are obtained by grouping several substances. Each item is evaluated with a score between 0-3. The sum of these seven component scores gives the total index score. Total score is between 0-21. A high total score indicates poor sleep quality.

SF-12 Quality of Life Scale (SF-12), is a scale that evaluates the quality of life for the last four weeks without focusing on a specific age group or disease group. High scores indicate good health status.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Messages For Your Health: A Cancer Screening Prevention Study	NCT02376023	Cervical Cancer	mHealth	25 Years - 64 Years	Pontificia Universidad Catolica de Chile
Motivation Program for Children With Cancer	NCT05982379	Childhood Cance...	Technology Base...	9 Years - 18 Years	Kırıkkale University
Geriatric and Oncological Evaluation With Technology for Holistic Healthcare Management for Older Multimorbid Patients.	NCT05423808	Geriatrics Medical Oncolog... Critical Pathwa... Digital Technol...	Health Professi... Holis Dashboard...	70 Years -	Universitaire Ziekenhuizen KU Leuven
Idylla EGFR Lung Trial	NCT04962191	Lung Cancer Technology Oncology	Idylla EGFR Mut...	18 Years -	Protean BioDiagnostics
Single frActIoN eighT Gray Palliative Radiotherapy With Modulated Intensity for Pain Reduction	NCT03554135	Bone Metastases Radiotherapy Technology	Personalization...	18 Years -	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Internet-Based Exercise and Diet Support in Prostate Cancer Survivors	NCT03406013	Cancer Survivor Prostate Carcin...	Written Informa... Prescription Technology Coaching	18 Years -	OHSU Knight Cancer Institute
Single frActIoN eighT Gray Palliative Radiotherapy With Modulated Intensity for Pain Reduction	NCT03554135	Bone Metastases Radiotherapy Technology	Personalization...	18 Years -	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Breast: Recovery After Axillary Node Clearance - Evaluating Limbs With E-Technology (the BRACELET Study)	NCT03635723	Breast Cancer Mobility Limita...	Activity monito...	-	Imperial College London
Breast: Recovery After Axillary Node Clearance - Evaluating Limbs With E-Technology (the BRACELET Study)	NCT03635723	Breast Cancer Mobility Limita...	Activity monito...	-	Imperial College London
The Effect of Digital Technology-Supported Education on Patients Undergoing Breast Reconstruction After Mastectomy: A Randomized Controlled Study	NCT06166953	Breast Cancer	digital technol...	18 Years - 75 Years	Baskent University
PC001- A Study to Evaluate the Usability of PointCheck	NCT04448301	Neoplasms Neutropenia	PointCheck	18 Years -	Leuko Labs, Inc.
Motivation Program for Children With Cancer	NCT05982379	Childhood Cance...	Technology Base...	9 Years - 18 Years	Kırıkkale University
IMPACT: Inactivity Monitoring and Physical Activity Controlled Trial	NCT01869348	Obesity Cardiovascular ... Cancer Diabetes Sarcopenia	Monitor interve...	55 Years - 79 Years	The University of Texas Medical Branch, Galveston

Spots Global Cancer Trial Database for technology

Every month we try and update this database with for technology cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for technology

Every month we try and update this database with for technology cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for technology cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.