Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

The assessment of the end points will be made at three moments: at baseline, at 8 weeks (at the end of the program) and at 12 months of follow-up. The intervention will consist in: 1)Feedback daily or weekly of physical exercise and diet through the application (notice) according to the records of diet and exercise and following recommendations of International Organizations 2) Participation in three sessions of seminars (1 hour each every 15 days) on habits of life healthy and cancer and the self-regulation through measurements performed by the application 3) Calls weekly to the patients of way individual to comment possible errors or doubts about the application, of 10 min of duration (8 calls).

Dietary and physical activity recommendations trough a mobile application

mHealth application

IRENE CANTARERO VILLANUEVA, PhD

The purpose of this randomized study is to assess the efficacy of a mobile application for the promotion of healthy lifestyle habits (diet and exercise) in colorectal cancer survivors (CCR).

Background: Among all types of cancer, colorectal cancer (CRC) is one of the most frequent, and Spain is among the countries with the highest incidence of CCR with a ratio of about 100,000 people. Fortunately the data of survival are very encouraging according to the National Cancer Institute, it is around 70% at 5 years when the cancer is regional and it could reaching up to 90% when it is more localized. During this survival, however, a high number of patients suffer physical and psychological sequelae that limited their quality of life.

This is why that, to try to minimize these effects, it is essential to try to instill healthy habits (food and physical exercise), since as it confirms the current literature, obesity is related to a lower survival and a greater presence of other diseases, and increased consumption of fruits and vegetables and physical activity practice improves the quality of life in survivors of CRC. However, changes in lifestyle are complicated to maintain long-term. In this sense, the technological development offers possibilities to try to resolve this lack of adherence in patients with cancer. However, the evidence highlights the need to improve knowledge about its applicability and efficacy in patients with this pathology betting on technologies more innovative.

Objective: The purpose of this randomized study is to assess the efficacy of a mobile application for the promotion of healthy lifestyle habits (diet and exercise) in CRC survivors. In a more specific way, analyze the effectiveness of the implementation to maintain healthy lifestyle habits in patients newly diagnosed with CRC through adherence to a healthy lifestyle (exercise and diet), as well as facilitate changes in clinical variables: body composition, quality of life, physical condition related to health (functional ability, strength and flexibility).

Methods: 54 patients will be recruited from the Virgen de las Nieves Hospital from Granada (Spain). Patients will be randomized in two groups: control and experimental group. The assessment of the end points will be made in IMUDS (Instituto Mixto Deporte y Salud) from Granada (Spain) at three moments: at baseline, at 8 weeks (at the end of the program) and at 12 months of follow-up. The intervention will consist in: 1)Feedback daily or weekly of physical exercise and diet through the application (notice) according to the records of diet and exercise and following recommendations of International Organizations 2) Participation in three sessions of seminars (1 hour each every 15 days) on habits of life healthy and cancer and the self-regulation through measurements performed by the application 3) Calls weekly to the patients of way individual to comment possible errors or doubts about the application, of 10 min of duration (8 calls). The control group will follow the usual indications of their oncologist and completion of the study will be offered access to the application.

Discussion: Health mobile applications (mobile health, mHealth) are potential tools to address the needs of cancer patients, because it enabling personalized interventions and the adherence to them. Previous studies have showed: 1) Are effective for weight loss in people with obesity or overweight. 2) You can count on are to promote a healthy lifestyle focused on the loss of weight in cancer patients. 3) Strategies based on self-regulation will not only improve the regulation of the exercise by the patient, but they also produce a greater adherence to the same. However, despite all these advances, are few them studies that have analyzed the efficiency of mobile applications as tool appropriate for foster the acquisition of habits of life healthy in cancer patients. Therefore are necessary studies that improve the adequacy of interventions to the needs of patients with CRC with support from technologies that show its effectiveness.

A Mobile Aplication for the Promotion of Healthy Lifestyle Habits in Patients With Colorectal Cancer

Effectiveness of a Mobile Application for the Promotion of Healthy Lifestyle Habits in Patients With Colorectal Cancer: a Randomized Controlled Trial

in kg/m2, will be assessed by conducting Dual-energy X-ray absorptiometry (DXA, discovery densitometer from HOLOGIC, QDR 4500W)

Fat mass (%): will be evaluated by conducting Dual-energy X-ray absorptiometry (DXA, discovery densitometer from HOLOGIC, QDR 4500W)

It will be measured with a plastic tape. Waist circumference was assessed midway between the lower rib margin and the top of the iliac crest (cm) at the end of normal breathing.

It will be measured with a plastic tape. Hip circumference was measured at the level of the greater trochanter.

it will be assessed though FITBIT CHARGE HR bracelet in kcal/day.

through a record of 24-hour, recording the amount of macronutrients (carbohydrates, lipids, proteins), micronutrients (vitamins and minerals), fiber and energy density.

the 6 minutes walking test will be used to measure the distance (m) that patients could walk in 6 minutes.

it will be assessed with trunk curl test. Patient through a trunk curl has to keep an isometric position separating the inferior angle of the scapulae from the stretcher as long as possible until 90 seconds as maximum.

it will be assessed with chair sit and reach test. Patients were instructed to slide their hands as long as possible to touch their toes. The centimeters that were missing (minus score) or exceeded(plus score) from the tip of the foot were registered.

Universidad de Granada

Vasoconstrictor Agents

Respiratory System Agents

All Drugs and Chemicals

Epinephrine

Racepinephrine

Epinephryl borate

Content to be delivered using a combination of short video and text-based information optimized for delivery via Quick Response (QR) codes for smartphones.

Self-directed application (app) that is downloaded to the participant's personal device. The app contains five informational videos, that provide an orientation to the content on the app, and discuss what colorectal cancer is, and the type of CRC screening tests that are available as well as a video with a personal history. There is a a National Cancer Institute (NCI) risk calculation tool, and a family history infographic. Once the videos have been viewed participants have the option to indicate if they wish to receive a call from the healthcare clinic to discuss scheduling an appointment for screening.

mHealth Application

Maria Thomson, Ph.D.

To determine the unmet needs, attitudes, barriers and facilitators of African American (AA)/ Black men use of colorectal cancer screening and describe how community leaders such as barbers may act as Community Champions to educate and facilitate screening participation.

Engaging Black Men in Colorectal Cancer Screening

SUCCEED: Engaging Black Men in Colorectal Cancer Screening (CRC) Screening

The number of participants that complete screening (any type)

The number of men that enroll for the intervention (application)

The number of participants that view the videos

The number of participants that complete Questionnaires (\>75%)

The number of participants that respond to the request to contact clinic/ navigation services

The number of participants that share content on social network

National Cancer Institute (NCI)

Virginia Commonwealth University

Skin and Connective Tissue Diseases

Behaviors and Mental Disorders

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Quality of Life

Neuroendocrine Tumor

Neuroepithelioma

Participants will be asked to use the LifeChamps platform and will be provided with the study equipment (sensors/home kit).

Participants will be provided with the study equipment, i.e., a mobile app, smartwatch, smart t-shirt, smart scale, location home sensor, and a micro-computer, with which they will need to interact with the devices for three months in the respective study phase (pre-pilot/feasibility trial). Specifically, participants should wear the activity tracker wristband (Fitbit Charge 4) as much as possible. The smart t-shirt should as well be worn daily as much as possible. Additionally, participants should use the smart scale to weigh themselves and the mobile app to fill in selected PROMs monthly, while the ambient home sensors (location home sensor (LOCS) and smart plug) will be passively collecting information about their everyday living during these three months. Lastly, participants' clinical and demographic data from the local EHRs will be collected.

LifeChamps Platform

Panagiotis Papachristou, MD/PhD

The purpose of this study is to collect data from various sources (PROM / PREM, sensors, journal data) to train AI based models in the LifeChamps digital platform in a pre-pilot, as well as partly implement a pilot/feasibility study to examine the applicability of the digital technology developed in LifeChamps, as well as the usability for patients (cancer survivors) and health care professionals

"The LifeChamps project (https://lifechamps.eu/) is creating a digital platform to support clinical teams to provide more integrated follow-up care to older patients with cancer. The digital platform will integrate data coming directly from the patient (patient-reported outcomes and sensor data from wearable devices), from the home environment (home sensors, weight scales), and from the clinical environment (data routinely collected via the Electronic Health Record). The digital platform will use big data analytics (machine learning) to process all data as part of predictive clinical algorithms for frailty and quality of life for older patients with cancer. Development of each clinical algorithm requires that the prototype model (or analytics engine) is trained using abundant real-world data to help consolidate the predictive ability and validity of the algorithms before the algorithms are deployed in the feasibility trial.

A prospective, time series design will be employed, whereby the LifeChamps platform will be deployed first during the pre-pilot in a total of 3 months; later in an interrupted time series feasibility trial during a period of 5 months.

Older patients with a cancer diagnosis (specifically melanoma) will be the target population for this study. Consecutive sampling will be used, whereby all older patients with cancer who meet the eligibility criteria will be approached and invited in the study. Each study participant will be involved in the study for 3 months or 5 months in total respectively. A 3-month recruitment period will be allowed and is overlapping with the two studies, bringing the total study duration to 6 months (from first patient being enrolled until last patient finishing data collection).

Patients aged 65 years and above, diagnosed with stage I-III melanoma skin cancer will be identified from Region Stockholm participating primary care facilities and the Melanoma patient association (Melanomföreningen) . The patients will be presented with the opportunity to participate in the study and screened based on the inclusion and exclusion criteria. Potential participants will be provided with the information sheet and the consent form, informed that should they decline to participate this will not change their current treatment and provided the opportunity to ask any questions they may have.

After written informed consent has been provided, the mini-COG will be used to evaluate study participants' cognitive function and impairment at baseline. The mini-COG consists of a 3-word recall and a clock-drawing test, and can be completed within 5 minutes. A score of less than 3/5 indicates the need to refer the patient for full cognitive assessment.

The researcher will also arrange for study participants to receive study equipment, i.e. home sensors, wearable activity sensors, smart weight scale, and mobile app. The researcher will arrange a suitable time for a home visit to install the home sensors and test functionality. The researcher will demonstrate use of study equipment to the participant, and reiterate that support with use of the technology will be available.

Data collection will involve a variety of sources, including the patient (patient-reported outcomes and sensor data from wearable devices), the home environment (home sensors, weight scales), and the clinical site (data routinely collected via the Electronic Health Record).

The following technology will be used:

Mobile devices:

Activity tracker wristband (FitBit charge 4). It will be used to passively monitor and collect data on heart rate, heart rate variability, steps, activity tracking, sleep monitoring, breathing rate, skin temperature and SpO2.

Smart T-shirt (Move Sense). It will be used to track participants heart rate (HR), respiration and movement (body position).

Mobile app (SALUMEDIA). It will be used to enable collection of patient-reported outcome measures (PROMs) and to forward this information along with the data gathered by the activity tracker and the smart scale to the Raspberry Pi Kit at home.

At home sensors / devices:

LOCS Home sensors: They will be used to monitor participants' daily activities e.g., to track ambulation and functioning. Study participants will be provided with 4 motion sensors, 1 door contact sensor, 2 corridor sensors, and a tag device.

Smart Scale (Withings Body+): It will be used to measure weekly body weight, body composition and body mass index.

Raspberry Pi (RPI) kit: As an edge gateway, RPI is hosting LOCS gateway, Movesense Gateway and data ingestion service. RPI will enable data collection and edge analytics and transfer of data to the LIFECHAMPS platform.

Selected study participant clinical and demographic data from the local EHRs will be collected and loaded onto the LifeChamps analytics engine. The data will be loaded by technical partners via the LifeChamps dashboard for processing and analysis. Data regarding recruitment rate (patients consenting / patients approached), participant retention in the study, reasons for study discontinuation (if offered), participant adherence with technology, issues with technology and need for troubleshooting will be recorded. These data will (a) be recorded by local researchers using bespoke 'recording logs' in the form of an Excel spreadsheet, and (b) remotely monitored and logged by technical partners involved in the distribution / management of the technology to be used in the trial as described above."

LifeChamps Feasibility Study

LIFECHAMPS: A Collective Intelligence Platform to Support Cancer Champions - Stockholm Pilot Use Case 2

According to GDPR and the Swedish Ethical Review Authority, data may be made available to those who comply with necessary ethical approvals and regulations for the planned data

Study recruitment rates, participant retention and adherence to study protocol will be calculated.

This outcome will be calculated by dividing the number of times the technology was used over the maximum times that technology can be used over the course of the study. It is a ratio between 0 and 1, with 1 being the best outcome.

The collected data will be used to train and test the analytical models. For example, the initial data from sensors will be refined, further, with statistical, spectral and supervised learning analyses to identify and extract possible patterns (e.g., activities of daily living) inside their signals. Sensor, EHR and PROM data will be all analysed together through exploratory algorithms (e.g., pairwise Markov random fields, Bayesian networks) to identify possible interactions and dependencies among their trajectories, mapping the frailty and QOL domains of elderly melanoma cancer patients across all the data collection process.

The usability of the LifeChamps platform will be measured through the System Usability Scale questionnaire with Likert type questions from 1 to 5, where 5 is strongly agree and 1 is strongly disagree on the ten statements of the SUS questionnaire.

Quality of life assessment as measured by LASA via 0-10 Likert scales, with 10 being the best.

PROM assesment of the FCRI Short Form 9-item questionnaire (Simard, S; Savard, J; 2015)

Assessment as measured by SEPI via 0-4 point Likert scales.

Aristotle University Of Thessaloniki

Hospital Universitario La Fe

University of Glasgow

Region Stockholm

Stomach Neoplasms

Stomach Diseases

Stomach Cancer

Esophageal Cancer

Participants randomised to the intervention group will be introduced to the mHealth prehabilitation programme delivered via a mobile app. Within this intervention group, participants will have access to a mHealth prehabilitation programme delivered and monitored via an app which will consist of a multimodal prehabilitation programme consisting of nutritional guidelines, improving well being and physical functioning prior to surgery.

The control group will receive standard pre-operative care within NHS Lothian for patients undergoing surgery for oesophago-gastric cancer which includes the enhanced recovery after surgery pathway. This pathway includes a pre-assessment, verbal advice only on prehabilitation interventions surrounding nutrition, well being and physical activity as well as a follow up post treatment.

The study will compare the delivery of a prehabilitation programme via a mHealth application against standard preoperative care for patients undergoing surgery for oesophago-gastric cancer

Asensei app

Alison Kelly, MRes

Dr Lisa Salisbury, PhD

Dr Gillian Baer, PhD

The overall aim of this study is to assess the feasibility of a mHealth prehabilitation programme delivered via a mobile app for people with oesophago-gastric cancer by evaluating its user satisfaction and acceptance. The research question asks what is the feasibility of a mHealth prehabilitation programme delivered via a mobile app for patients with oesophago-gastric cancer?

The primary aim of this single centred feasibility randomised controlled trial (RCT) is to explore the recruitment, adherence, and compliance of taking part in a mHealth prehabilitation programme delivered for 6 weeks via a mobile app prior to oesophago-gastric surgery. This study will develop a prehabilitation programme to investigate the feasibility and impact of delivering prehabilitation via a mobile app to patients with a diagnosis of oesophago-gastric cancer before surgery.

The study will test a six-week mHealth prehabilitation programme delivered via a modified mobile application called the asensei app. Asensei is a commercial company who have already successfully developed a digital platform known as the asensei app that delivers tailored training with individualised programmes and automated responsive feedback for the fitness industry via mobile applications. In summary, participants recruited to the study will require three visits to the hospital for measures to be taken. Outcome measurements will be taken at baseline (T0), prior to surgery (T1) and 30 days post surgery (T2). Outcome measures relating to feasibility, physical and nutritional functioning as well as quality of life will be collected at the above specified three time points (T0,1,2). There will also be weekly phone calls and one to one discussion after the six weeks of prehabilitation to explore how useful people have found the app and how easy and engaging it was to navigate. This study will gain valuable insight into the role mHealth applications could offer in preventing functional decline, improving quality of life and preventing secondary complications in patients with a diagnosis of cancer prior to surgery.

Single centred feasibility randomised controlled trial (RCT)

Prehabilitation Via a Mobile Application in Oesophago-gastric Cancer

An Investigation of the Feasibility and Impact of a mHealth Prehabilitation Programme for Patients With Oesophago-gastric Cancer: The mPOC Study

To collect insights into participants views on positive and negative experiences or impacts and thoughts on the asensei app and prehabilitation programme participation. Positive and negative experiences within a qualitative interview may indicate higher or lower ratings associated with the mobile app. For example, positive feedback may indicate that participants are more likely to recommend the app to others, which is a valuable indicator of user satisfaction and potential for growth. Negative feedback may reflect user frustration with the app's performance or limitations.

Recruitment will be measured by analysing the proportion of individuals who take up the offer of a mHealth prehabilitation programme delivered via the asensei app prior to surgical intervention.

Adherence with the mHealth prehabilitation will be calculated by analysing the percentage of participants who consistently engage with the asensei app and complete the prescribed prehabilitation programme.

Compliance will be measured by assessing the extent to which participants adhere to the recommended prehabilitation protocols as well as the study guidelines.

Fidelity of the asensei app use will be measured using the modified mobile application rating scale (mMARS). This scale is a well-established framework for classifying and assessing the objective and subjective quality of apps. The scale assesses app quality which is rated on a 5-point scale from "1.Inadequate" to "5.Excellent". The modified mobile application rating scale typically ranges from 1 to 5, with 1 being the lowest rating and 5 being the highest. Higher scores generally indicate better user satisfaction and positive experiences with the mobile application. It suggests that users find the app to be more useful, user-friendly and enjoyable. Lower scores typically suggest dissatisfaction or negative experiences with the mobile application where users may find the app less useful, difficult to use or unenjoyable. Lower scores could also indicate issues with functionality, design or overall user experience.

Usability of the asensei app in terms of user satisfaction will be measured through semi structured interviews to collect participant feedback regarding the applications usability, perceived usefulness, and satisfaction. Higher and lower subjective ratings collated during the interview could represent different aspects of the app's performance and user experience. For example, a higher rating within interviews among participants may typically represent greater satisfaction with the mobile app with an increase likelihood to find the app user friendly, useful, and enjoyable to use. On the other hand, lower subjective feedback may typically signify dissatisfaction with the app.

Any adverse effects of using the asensei app will be measured through participant monitoring via agreed weekly phone calls throughout the prehabilitation programme. These phone calls will collect data on any related treatment-emergent adverse events. Any reported events or concerns will be analysed systematically, and any events reported will be categorized according to severity, frequency, and the nature of the adverse effects.

Preliminary data on physical activity will subjectively measure physical activity using the self-administered Godin Leisure Time Exercise Questionnaire which is a validated self-reported physical activity measurement used in cancer care. This will be assessed for change at three different time points: at baseline (T0), pre surgery (T1) and 30 days post-surgery (T2). The minimum and maximum values within the questionnaire used ranges from (0-119) where higher scores indicate higher level of leisure time exercise participation.

The 6-minute walk test (6MWT) will assess the distance walked over 6 minutes as a sub-maximal test of aerobic capacity. This outcome measure will be used to determine changes in physical function levels and cardiorespiratory fitness. This will be assessed for change at three different time points: at baseline (T0), pre surgery (T1) and 30 days post-surgery (T2). The minimum score is zero indicating that the participant was unable to walk any distance within the six minute time frame and the highest score is the distance walked by the participant in six minutes.

The timed up and go test (TUAG) will assess a person's mobility and balance using the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. This will be assessed for change at three different time points: at baseline (T0), pre surgery (T1) and 30 days post-surgery (T2). The lower the time score represents the shortest time taken to complete the task, indicating better mobility and functional ability. The higher the time score represents the longest time taken to complete the task suggesting potential mobility issues or functional limitations.

The Five times sit to stand test (5XSST) will assess lower extremity strength and frailty in patients with cancer. It is a simple test that evaluates the time taken to complete five repetitions of standing up from a seated position and sitting back down again. This will be assessed for change at three different time points: at baseline (T0), pre surgery (T1) and 30 days post-surgery (T2). The lowest score is the shortest time taken to complete the task, indicating better lower body strength and mobility. The highest score is the longest time taken to complete the task, suggesting potential difficulties in lower body strength and functional mobility.

Anthropometry will be assessed as height, weight, and body composition. Body composition will be assessed and calculated using Body Mass Index in the standard manner as height and weight. These multiple measurements will be aggregated to arrive at one reported value (e.g., weight and height will be combined to report BMI in kg/m) This will be assessed for change at three different time points: at baseline (T0), pre surgery (T1) and 30 days post-surgery (T2).

The handgrip test will be assessed and measured using a hand dynamometer to assess for grip strength. Handgrip strength can be used in cancer patients to evaluate nutritional risk and the need for nutritional intervention. This will be assessed for change at three different time points: at baseline (T0), pre surgery (T1) and 30 days post-surgery (T2). It measures the maximum force a person can generate while squeezing a handgrip dynamometer. The score is typically measured in kilograms and indicates the strength of the participants hand muscles. The lowest score is the weakest grip strength measurement achieved by the participant and the highest score is the strongest grip strength measurement obtained during the test.

The Patient Generated Subjective Global Assessment questionnaire (PG-SGA) will be used as an assessment tool to identify those most at risk of malnutrition. This will be assessed for change at three different time points: at baseline (T0), pre surgery (T1) and 30 days post-surgery (T2). It does not have a specific numerical score range like some other tests. Instead it involves a series of questions and assessments that are used to evaluate a participants weight changes, dietary intake, symptoms and functional capacity. The results are typically categorised into different levels of malnutrition of nutritional risk, ranging from well nourished to severely malnourished.

The patient health questionnaire (PHQ-9) will be used as an assessment tool to identify those participants in need of further support out with the universal programme provided by the asensei app. This will be assessed for change at three different time points: at baseline (T0), pre surgery (T1) and 30 days post-surgery (T2). The PHQ-9 is a self assessment tool used to screen and assess the severity of depression. It consists of nine questions that measure the frequency of various depressive symptoms over the past two weeks. The PHQ-9 scores range from 0-27, with higher scores indicating greater severity of depressive symptoms and the lowest score is 0 indicating the absence of depressive symptoms.

The EORTC QLQ-OG25 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire- Oesophagogastric Module 25) is a validated screening tool used in the quality-of-life metric pilots for patients with oesophageal-gastric cancer to be assessed for change at three different time points: baseline (T0), pre surgery (T1) and 30 days post-surgery (T2). The scoring for the EORTC QLQ-OG25 questionnaire is not a simple numerical range. It involves transforming raw scores into a scale of 0 to 100, where higher scores represent better functioning or higher levels of symptomatology, depending on the question. For example, higher scores on functional scales indicate better function and well-being, while higher scores on symptom scales indicate more severe symptoms. The scores are then interpreted in relation to the patient's condition and the context of their cancer diagnosis and treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Mobile Aplication for the Promotion of Healthy Lifestyle Habits in Patients With Colorectal Cancer	NCT02837159	Colorectal Canc...	mHealth applica...	18 Years - 85 Years	Universidad de Granada
Engaging Black Men in Colorectal Cancer Screening	NCT05980182	Colorectal Canc... CRC Behavior	mHealth Applica...	45 Years - 74 Years	Virginia Commonwealth University
LifeChamps Feasibility Study	NCT05990634	Melanoma (Skin)	LifeChamps Plat...	65 Years -	Region Stockholm
Prehabilitation Via a Mobile Application in Oesophago-gastric Cancer	NCT06046846	Oesophageal Can... Gastric Cancer Prehabilitation mHealth Applica...	Asensei app	18 Years -	Queen Margaret University
A Mobile Aplication for the Promotion of Healthy Lifestyle Habits in Patients With Colorectal Cancer	NCT02837159	Colorectal Canc...	mHealth applica...	18 Years - 85 Years	Universidad de Granada

Spots Global Cancer Trial Database for mhealth application