Patients in the intervention group will receive weekly teleconsultation of 30 minutes during 8 weeks through the secure Edumeet platform. In pilot 1, tele-rehabilitation training will be performed by a remote physiotherapist and will consist of a series of rehabilitation exercises. In pilot 2, tele-psychological support will be performed by a remote psychologist and will consist of techniques for managing emotions and stress. In the intervention group, patients will also have the possibility to wear a smartwatch to automatically collect physical parameters.

Patients in the control group will receive usual care.

Pilot 1a/b : the tele-rehabilitation intervention in BC or H\&N operated patients will consist of a series of exercises. The physiotherapist during teleconsultation rehabilitation program will explain to the patient how to perform the movements and regulate breathing. Practical advice on correct and incorrect habits will also be dispensed by the physiotherapist during the teleconsultation.

Pilot 2: the tele-rehabilitation intervention will consist of tele psychological support performed by a trained psychologist in each participating center It will consist of the learning of techniques for managing negative emotions, for relaxation and for implementing effective behavioural and coping strategies.

For each group, the TC will be scheduled every week for 8 weeks. The session will be available on a secure platform (Edumeet). Moreover, if they agree to, patients will also wear a smart watch to monitor physical parameters such as physical activity, sleeping and heart rate.

Telemedicine

Andrea Pace, Dr

Victoria Leclercq, PhD

Timon Vandamme, Dr

Contantinos Zambogou

Angelos Kassianos, Dr

Anastasia Constantinidou

Eleni Timotheadou

József Lövey, Dr

Des OToole

Maria C Piccirillo

Viktoras Rudzianskas

Jolanta Paskeviciene

Marija Turlinksienė

Rui Soares

Joana Dias

Maria Moura

Otilia Romano

Eunice Silva

Cvetka Grašič Kuhar

Ignacio Durán

David Vicente

The integration of teleconsultation (TC) and telemonitoring (TM) in cancer patients care may allow to improve person-centered care and patients' empowerment.

The eCAN JA explores the role of telemedicine tools (i.e. TC \& TM) in clinical trials focusing on tele-rehabilitation and tele-psychological support in different populations of cancer patients in 10 European countries. The pilots will be conducted among 354 patients affected by breast (BC, pilot 1a), head \& neck (H\&N, pilot 1b) and advanced (pilot 2) cancers.

The main aim is to assess the effect of TC and TM program focused on rehabilitation and psychological support for cancer patients on patient reported outcomes measures (PROMs) in three pilots compare to usual care.

Patients will be randomly assigned either to the intervention or control groups using a 1:1 ratio. Patients in the intervention group will receive weekly TC of 30 minutes during 8 weeks through the secure Edumeet platform. In pilot 1, tele-rehabilitation training will be performed by a remote physiotherapist and will consist of a series of rehabilitation exercises. In pilot 2, tele-psychological support will be performed by a remote psychologist and will consist of techniques for managing emotions and stress. In the intervention group, patients will also have the possibility to wear a smartwatch to automatically collect physical parameters. Patients in the control group will receive usual care.

PROMs (i.e. quality of life, distress and pain) and physical parameters (i.e. physical activity, sleep quality and heart rate) will be monitored by a dedicated telemonitoring systems. A secure web platform will provide dashboard to clinicians for decision support. Patients' experience and costs data will be also collected. The results of the eCAN project will improve our knowledge on benefits and risks for TC and TM in cancer patients care.

Telerehabilitation and Tele-psychological Support in Cancer Patients eCAN JA

Telerehabilitation and Tele-psychological Support in Cancer Patients: the Pilots Projects of eCAN JA

physical activity, number of steps, will be collected via wearable devices

The average sleep quality (light sleep, deep sleep, REM sleep) will be collected via wearable device (Garmin watche)

Daily heart rate (beats per minute) trend will be collected via wearable device (Garmin watche)

Costs that arose for patients will be collected using a patient-reported cost questionnaire.

usability of the teleconsultation program and telemonitoring with mHealth App Usability Questionnaire (MAUQ) for Standalone mHealth Apps Used by Patients

usability of the teleconsultation program and telemonitoring with TELEHEALTH USABILITY QUESTIONNAIRE (TUQ)

Visual Analogical Scale (VAS). The ends are defined as the extreme limits of the parameter to be measured (orientated from the left (0 the worst) to the right (100 the best).

NCCN Distress thermometer.Distress is an unpleasant experience of a mental, physical, social, or spiritual nature. It can affect the way you think, feel, or act. Distress may make it harder to cope with having cancer, its symptoms, or its treatment. Please circle the number (0-10) that best describes how much distress you have been experiencing in the past week, including today.

European Commission

Sciensano

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Anti-Inflammatory Agents

All Drugs and Chemicals

Triamcinolone

Triamcinolone Acetonide

Triamcinolone hexacetonide

Triamcinolone diacetate

Glucocorticoids

Hormones

Hormone Antagonists

In addition to routine care, the "HomMed Telemonitor" wireless telemonitoring system (intervention)will be used in the patient's home for 14 days to alert the clinical research nurse to changes in patients conditions in order to contact them to teach self-management. The Honeywell HomMed Genesis™ DM Remote Patient Care Monitor will be used to measure temperature, pulse, oxygen level,weight and blood pressure. The telemonitor will also ask for a YES or NO response to questions on symptoms such as difficulty breathing. Research nurses review the data daily and call the participant for 2 weeks, and continue to monitor outcomes for 2 months.

Traditional physician ordered post-hospital care for patients with lung CA in rural WV requires patients to make an outpatient office/ clinic visit two to three weeks after discharge;a few patients receive homecare service referrals. No attempt to change care - just monitor what is used and collect study data at Discharge, 2 weeks, one month and two months.

A "HomMed Telemonitor" wireless telemonitoring system collects data on a daily basis, including heart rate, blood pressure, oxygen level, body temperature, weight, responses to 9 pre-programmed questions (including difficulty breathing, fatigue, limited activities, difficulty taking meds, pain). Telemonitored results are transmitted to the research office for analysis and contact to patient by clinical research nurses.

HomMed Telemonitor

Georgia L Narsavage, PhD, MSN

The purpose of this study is to learn more about using a home machine "Telemonitor" to find problems people with lung cancer may have after being discharged from the hospital and help them manage problems by contacting their healthcare provider.The study hypothesis is that patients with lung CA using short-term (14 days)home telemonitors, educated/coached by nurses on telemonitor data risks/implications for the first two weeks after hospital discharge, will be able to self-report their signs/ symptoms to the clinician resulting in decreased use of costly health care resources over 60 days.

All patients in the study will receive usual care after hospital discharge. This study also involves an interview and review of your medical records, and uses the "telemonitor" machine to measure your temperature, pulse, oxygen level,weight and blood pressure. The telemonitor will also ask you to press YES or NO buttons in response to questions on your symptoms such as difficulty breathing. Research nurses will come to your home 3 times and it will take about 30 minutes for each visit for the nurse to record the information using the telemonitor. You will also be asked to fill out a survey about your ability to do activities and your health status. This will take approximately another 30 minutes. You may or may not receive the small telemonitor (about as big as a large book) for 14 days after discharge to provide additional information to the researchers. If you receive the monitor for the full 14 days, you or someone you ask us to train will be taught to use the monitor every morning to collect information on how you will "talk" to you to tell you to put a blood pressure cuff on your arm and an oxygen measurer on your finger. You will step on a scale to take your weight and you will use a forehead sensor to take your temperature. The blood pressure, weight, temperature, your pulse, and your oxygen level will be recorded by the monitor. It will then ask you at least 10 questions and you will push a yes or no button indicating how much difficulty you are having with your daily activities and shortness of breath. The monitor will then connect to your telephone line using a no-charge "800" number and transmit the information to the researchers. If you do not have a phone, a special antenna will be connected to the monitor to transmit the information wirelessly. The nurse will call you every day for the 14 days when you have the monitor. If you do not receive the monitor for the full 14 days, you will still have the monitor used by the nurse when you are visited at least 3 times at home to gather information on how you are doing after hospital discharge. These home monitor visits will be within 2 days after discharge, 2 weeks after discharge, and 2 months after discharge. The main difference is that the monitor will not be left in your home but will be brought by the nurse on each visit. You will also receive a phone call to ask you questions about the study at 1 month after discharge. If you do not have a phone, you will receive another home visit. Whether or not you get the monitor for the full 14 days will be determined randomly by computer before the nurse visits you at home the first time. are doing. The monitor will turn on each day at the same time; the monitor

Home Telemonitoring for Patients With Lung Cancer

PILOT: Home Telemonitoring for Self-Management Education of Patients With Lung Ca

Changes in temperature measured by telemonitor daily over 14 days after hospital discharge

Changes in pulse rate measured by telemonitor daily over 14 days after hospital discharge

Changes in blood pressure measured by telemonitor daily over 14 days after hospital discharge

Changes in SpO2 measured by telemonitor daily over 14 days after hospital discharge

Changes in weight measured by telemonitor daily over 14 days after hospital discharge

Numeric rating for dyspnea, from 0 to 10 with a lower number being a decrease in dysnea. Symptom data requiring yes-no answers to whether the symptom is worse today than yesterday : dyspnea are collected daily via telemonitor for 14 days.

Pulmonary Functional Status Scale (PFSS-11) , scoring from 0 to 10 with increasing scores indicating an improvement in functioning. Symptom data requiring yes-no answers to whether the symptom is worse today than yesterday : general functioning activities, are collected daily via telemonitor for 14 days.

Numeric rating for pain (0 to 10 scale) with a lower number indicating less pain. Symptom data requiring yes-no answers to whether the symptom is worse today than yesterday : pain are collected daily via telemonitor for 14 days.

National Cancer Institute (NCI)

West Virginia University

The PI left the institution and a small results document has been found, the documents does not contain adverse events information. All efforts were to made to retrieve adverse events information, but were unsuccessful.

In addition to routine care, the "HomMed Telemonitor" wireless telemonitoring system (intervention)will be used in the patient's home for 14 days to alert the clinical research nurse to changes in patients conditions in order to contact them to teach self-management. The Honeywell HomMed Genesis™ DM Remote Patient Care Monitor will be used to measure temperature, pulse, oxygen level,weight and blood pressure. The telemonitor will also ask for a YES or NO response to questions on symptoms such as difficulty breathing. Research nurses review the data daily and call the participant for 2 weeks, and continue to monitor outcomes for 2 months.

HomMed Telemonitor: A "HomMed Telemonitor" wireless telemonitoring system collects data on a daily basis, including heart rate, blood pressure, oxygen level, body temperature, weight, responses to 9 pre-programmed questions (including difficulty breathing, fatigue, limited activities, difficulty taking meds, pain). Telemonitored results are transmitted to the research office for analysis and contact to patient by clinical research nurses.

Telemonitor

Routine Care for Patients With lungCa

PI left the institution and demographic information was not broken down into arms.

Telemonitor:

In addition to routine care, the "HomMed Telemonitor" wireless telemonitoring system (intervention)will be used in the patient's home for 14 days to alert the clinical research nurse to changes in patients conditions in order to contact them to teach self-management. The Honeywell HomMed Genesis™ DM Remote Patient Care Monitor will be used to measure temperature, pulse, oxygen level,weight and blood pressure. The telemonitor will also ask for a YES or NO response to questions on symptoms such as difficulty breathing. Research nurses review the data daily and call the participant for 2 weeks, and continue to monitor outcomes for 2 months.

HomMed Telemonitor: A "HomMed Telemonitor" wireless telemonitoring system collects data on a daily basis, including heart rate, blood pressure, oxygen level, body temperature, weight, responses to 9 pre-programmed questions (including difficulty breathing, fatigue, limited activities, difficulty taking meds, pain).

Routine care for patients with lungCa:

Traditional physician ordered post-hospital care for patients with lung CA in rural WV requires patients to make an outpatient office/ clinic visit two to three weeks after discharge;a few patients receive homecare service referrals. No attempt to change care - just monitor what is used and collect study data at Discharge, 2 weeks, one month and two months.

Telemonitor and Routine Care for Patients With lungCa

Age, Continuous

All efforts have been made to contact the PI, but the only available information is a small results document. The results information found was not always broken down by arm and the gender and race information provided include information from a 10 person sub-study. It cannot be determined which participants were from the sub-study, so information related to gender and race for this specific study cannot be determined.

Sex: Female, Male

Race (NIH/OMB)

PI has left the institution and a report about the results was found, but the information within the report is not always broken down between the arms.

Georgia L Narsavage

Results information was not available broken down by arm.

Changes in Telemonitor Data From Baseline: Temperature

Results information was not available broken down by arm

Changes in Telemonitor Data From Baseline: Pulse Rate

Diastolic

Systolic

Changes in Telemonitor Data From Baseline: Blood Pressure

Changes in Telemonitor Data From Baseline: SpO2

Changes in Telemonitor Data From Baseline: Weight

In addition to routine care, the "HomMed Telemonitor" wireless telemonitoring system (intervention)will be used in the patient's home for 14 days to alert the clinical research nurse to changes in patients conditions in order to contact them to teach self-management. The Honeywell HomMed Genesis™ DM Remote Patient Care Monitor will be used to measure temperature, pulse, oxygen level,weight and blood pressure. The telemonitor will also ask for a YES or NO response to questions on symptoms such as difficulty breathing. Research nurses review the data daily and call the participant for 2 weeks, and continue to monitor outcomes for 2 months.

HomMed Telemonitor: A "HomMed Telemonitor" wireless telemonitoring system collects data on a daily basis, including heart rate, blood pressure, oxygen level, body temperature, weight, responses to 9 pre-programmed questions (including difficulty breathing, fatigue, limited activities, difficulty taking meds, pain).

Changes in Telemonitor Symptoms Recorded From Baseline: Dyspnea

Changes in Telemonitor Symptoms Recorded From Baseline: Functioning

Changes in Telemonitor Symptoms Recorded From Baseline: Pain

Overall Study

Symptoms and General Pathology

Neoplasm Metastasis

Neoplastic Processes

Patients undergo standard face-to-face follow up visits at 2, 6, 12, and 24 weeks after surgery. Patients also undergo a physical activity assessment over 15 minutes.

Patients undergo standard face-to-face follow up visits as in Group I. Patients also undergo mobile surveillance comprising use of a mobile device application to send photos and videos to study staff and engage in video conferences at 3, 7, 13, and 25 weeks after surgery.

Undergo surgical wound and physical activity monitoring

Monitoring Device

Physical Activity Measurement

Quality-of-Life Assessment

Questionnaire Administration

Standard Follow-Up Care

Survey Administration

Robert L Satcher

This randomized pilot trial studies telemonitoring after surgery to preserve limb function in optimizing mobility in cancer survivors with cancer spread to the bone. The use of mobile devices for telemonitoring may improve the delivery of cost-effective, high-quality, standardized surveillance of cancer survivors.

PRIMARY OBJECTIVES:

I. To develop and evaluate the feasibility of a method that enhances surveillance in cancer survivors by using mobile devices in addition to face-to-face visits following surgery for bone metastases.

SECONDARY OBJECTIVES:

I. To evaluate how well the face-to-face follow-up format can be adapted to using mobile devices for remote surveillance.

II. Limited efficacy testing of the remote surveillance program. III. To obtain information on acceptability of the mobile surveillance format by patients and clinicians.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I (CONTROL): Patients undergo standard face-to-face follow up visits at 2, 6, 12, and 24 weeks after surgery. Patients also undergo a physical activity assessment over 15 minutes.

GROUP II (MOBILE SURVEILLANCE): Patients undergo standard face-to-face follow up visits as in Group I. Patients also undergo mobile surveillance comprising use of a mobile device application to send photos and videos to study staff and engage in video conferences at 3, 7, 13, and 25 weeks after surgery.

After completion of study, patients are followed up at 24-25 weeks.

Telemonitoring After Surgery to Preserve Limb Function in Optimizing Mobility in Cancer Survivors With Skeletal Metastases

Using Telemonitoring to Optimize the Mobility of Cancer Survivors With Skeletal Metastases After Surgery to Preserve Limb Function

Inter-rater agreement on the physician assessed score defined as less than 10% difference between the Musculoskeletal Tumor Society (MSTS) scores evaluated using video vs. face-to-face follow ups.

Participant considered having completed the follow-up assessments if the three outcomes are documented for the 2-, 6-, 12, and 24-week evaluations. Follow-up assessment information taken from Musculoskeletal Tumor Society Scores (MSTS), Timed "Up and Go" test (TUG), and Patient Reported Outcomes Measurement Information System (PROMIS).

M.D. Anderson Cancer Center

Patients undergo standard face-to-face follow up visits at 2, 6, 12, and 24 weeks after surgery. Patients also undergo a physical activity assessment over 15 minutes.

Physical Activity Measurement: Undergo physical activity measurement

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Standard Follow-Up Care: Undergo standard follow-up care

Survey Administration: Ancillary studies

Phase I (Standard Follow up, Physical Activity Measurement)

Patients undergo standard face-to-face follow up visits as in Group I. Patients also undergo mobile surveillance comprising use of a mobile device application to send photos and videos to study staff and engage in video conferences at 3, 7, 13, and 25 weeks after surgery.

Monitoring Device: Undergo surgical wound and physical activity monitoring

Physical Activity Measurement: Undergo physical activity measurement

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Standard Follow-Up Care: Undergo standard follow-up care

Survey Administration: Ancillary studies

Phase II (Mobile Surveillance)

Total

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

Due to software issues and depletion of funds the protocol was terminated early and the participants did not complete assessments per protocol at given point, no data collected.

Dr. Robert Satcher, Associate Professor, Orthopaedic Oncology

Inter-Rater Agreement on the Physician Assessed Score

Completion of Follow-Up Assessments

Phase I (Control)

Behaviors and Mental Disorders

Quality of Life

Patients assigned to the active intervention group will have access to a smartphone application named "Contigo." This application is designed to identify signs and symptoms of oncology drug toxicity while providing educational content. It equips patients with the necessary tools to manage typical clinical situations associated with the diagnosis and treatment of their disease.

Individuals designated to the traditional follow-up group will undergo standard care, including in-person check-ups as determined by their attending physician.

Contigo, a smartphone app, focuses on two main goals: monitoring cancer patients for early signs of drug toxicity and offering educational content to empower them in managing clinical challenges linked to their diagnosis and treatment. Monitoring involves patients inputting experiences via oncology-related questionnaires, with weekly checks for chemotherapy toxicity using a validated questionnaire (PRO-CTCAE). Severe cases trigger alerts, while milder ones receive educational guidance. Data collected is shared with healthcare providers. Educational content, backed by scientific evidence and expert collaboration, covers cancer-specific topics and healthcare processes to enhance patients' self-awareness and self-care practices.

Contigo Application

Felipe T Martinez, MD, MSc

Carla Taramasco, PhD

Bruno Nervi, MD

Manuel Gonzalez, PhD

This interventional study aims to explore the potential of a smartphone app, Contigo, in enhancing the quality of life for patients with various cancers compared to standard care. The investigators will asses effects on quality of life, depressive symptoms, and appointment adherence.

The primary objective of this study is to determine if utilizing a smartphone app for disease monitoring improves the self-reported quality of life using validated questionnaires in patients with diverse solid cancers compared to standard care. Secondary objectives focused on evaluating its impact on depressive symptoms and assessing adherence to in-person appointments. This study involves a randomized trial among patients recently diagnosed with specific forms of cancer and undergoing curative treatment at the UC Christus Cancer Center. The eligible participants, 80 adults with recent histologically confirmed cancer diagnoses, will be randomized to receive either the smartphone application (Contigo) or standard educational care. Randomization will be performed independently using an allocation sequence that will be kept concealed from clinical investigators. Contigo offers two primary functions: monitoring cancer patients and delivering educational content to aid patients in dealing with common clinical situations related to their disease. The study will assess outcomes such as quality of life changes, depressive symptom development, and adherence to in-person appointments. All analyses will be undertaken under the intention to treat principle by a statistician unaware of treatment allocation.

Participants will be randomly allocated in a 1:1 fashion to receive the smartphone application or usual follow-up care.

Outcome assessors, investigators and analysts will be kept unaware of treatment allocation. However, due to the characteristics of the intervention, it is not possible to mask participants.

Effects of Telemonitoring in Quality of Life Amongst Cancer Patients

Effects in Quality of Life of a Telemonitoring Platform Amongst Patients With Cancer: A Randomized Trial

Anonymized individual participant data, encompassing clinical characteristics and outcomes, will be accessible to fellow researchers upon reasonable request. This access can aid in conducting a systematic review on telemonitoring platforms for providing care to cancer patients.

Quality of Life as assessed by the EuroQol 5 Dimension (EQ-5D) questionnaire. The index score ranges from 0 to 1, with higher values indicating an overall better quality of life.

Development of symptoms of depression as evaluated by the Patient Health Questionnaire 9 (PHQ-9) scale. Scores can range from 0 to 27, with higher scores increasing the probability of depression.

Adherence to in-person medical appointments, as established by the attending physician of each participant. This outcome will be expressed as the proportion of visits attended by each patient.

Centro para la Prevención y Control del Cáncer (CECAN), Santiago, Chile

Universidad Nacional Andres Bello

Associate Professor

Patients allocated to the active intervention group will receive a smartphone application called Contigo. This tool aims to detect signs and symptoms of oncology drug toxicity and delivering educational content that enables the patient to have tools to address common clinical situations associated with the diagnosis and treatment of their disease.

Those assigned to the traditional follow-up group will receive standard care and in-person check-ups as determined by their attending physician.

Contigo, a smartphone application, aims to achieve two main objectives: monitoring cancer patients for early detection of oncology drug toxicity signs and providing educational content to empower patients in handling clinical challenges tied to their diagnosis and treatment. Monitoring involves modules and sub-modules where patients input experiences through oncology-related questionnaires. Weekly checks for chemotherapy toxicity-associated symptoms use a validated questionnaire (PRO-CTCAE). Severe toxicity triggers immediate alerts, while milder cases receive educational guidance. Data collected is shared with healthcare providers. Educational health content has been created by professionals, encompassing cancer-specific topics, healthcare processes, administration, health coverage, self-awareness, and self-care practices. The content is based on scientific evidence, official reports, and group sessions involving healthcare professionals and cancer patients.

Felipe Martinez, MD, MSc

Manuel Espinoza, PhD

The primary objective of this trial is to evaluate the impact of a telemonitoring platform on patient satisfaction with care amongst adult cancer patients receiving chemotherapy. The key questions it seeks to address revolve around the potential improvements in both quality of life and satisfaction with healthcare. Participants in the trial will be provided with a specialized application developed by a team of experienced oncology professionals. Their quality of life and healthcare experience will be compared with that of the control group, who will only receive the standard in-person check-ups established by their healthcare team.

This protocol describes a randomized parallel-group clinical trial among recently diagnosed patients with solid carcinomas preparing for curative intent chemotherapy at Hospital Sótero del Río and UC-Christus Health Network centers. Eligible adult patients (\>18 years) diagnosed with lung, gastric, gallbladder, colon, breast, or cervical carcinoma, scheduled for outpatient curative intent chemotherapy within UC-Christus Health Network or Hospital Sotero del Rio from November 2023 to July 2024, proficient in Spanish, and possessing a smartphone (iOS® or Android®) will be recruited. Exclusions include those undergoing concomitant radiotherapy, sensory impairments hindering app use, cognitive or psychiatric issues, and unwillingness to participate. Participants will be randomized 1:1 to receive either the Contigo smartphone application or standard care. Contigo aims to monitor chemotherapy toxicity symptoms and deliver cancer-related educational content. The application includes modules addressing cancer care, self-perception of health, patient experiences, frequently asked questions, community resources, and scheduling. Information collected by the app will be available to healthcare providers. Patients will receive the app for free and undergo training on its usage. Weekly toxicity assessments using Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) will be conducted. The control group will receive standard in-person care. The primary outcome is patient experience during chemotherapy, measured using the OUT-PATSAT-35 questionnaire three months after randomization. Secondary outcomes include severe chemotherapy-associated toxicity, quality of life, and user satisfaction with the application. A sample size of 80 participants (40 per group) was calculated. Descriptive analysis will utilize means, standard deviation, frequencies, and percentages. Inferential analysis will involve t-tests, Mann-Whitney U tests, Fisher's Exact Test, and Kaplan-Meier survival curves. All analyses will adhere to intention-to-treat principles and use Stata v.16.0® software. No subgroup analyses have been programmed.

Patients will be randomized in a 1:1 ratio using a permuted block method to receive one of the two intervention strategies.

Telemonitoring Platforms and Chemotherapy-Associated Toxicity

Differential Effects of a Telemonitoring Platform in the Development of Chemotherapy-Associated Toxicity: A Randomised Trial

Anonymized individual participant data including clinical characteristics and outcomes will be made available to other researchers on reasonable request, such as to inform the conduction a systematic review on telemonitoring platforms for providing care to patients with cancers.

Patient Satisfaction with Healthcare Services Provided using the European Organisation for Research and Treatment of Cancer Satisfaction with Cancer Care for Outpatients questionnaire (EORTC OUTPATSAT-35). Scores can range from 0 to 100 points, with higher scores implying greater satisfaction with care.

Quality of Life scores as assessed by the EuroQol 5 Dimension (EQ-5D) questionnaire. The index score ranges from 0 to 1, with higher values indicating an overall better quality of life.

Proportion of patients who develop a severe adverse event attributable to cytotoxic chemotherapy. Severe events will be those of grade 3 to 5 of the Common Terminology Criteria for Adverse Events classification.

Propotion of patients who require hospitalizations due to an adverse event attributable to cytotoxic chemotherapy

Proportion of patients who require a reduction in their chemotherapy dose in each group.

Median number of emergency department visits in each study group

Infections

COVID-19

Pneumonia

Pneumonia, Viral

Communicable Diseases

Respiratory Tract Infections

Virus Diseases

Coronavirus Infections

Coronaviridae Infections

Nidovirales Infections

RNA Virus Infections

All patients were presented the digital PROMs platform during their chemotherapy

At inclusion the patient received a unique login code which he/she used to start the care path. After signing the informed consent on the digital pathway, the patient needed to fill in the questionnaires that were presented at fixed time points throughout this study.

Based on the data collected from the questionnaires the patient received customized information and advice. In case of COVID-19, the information and advice was based on the guidelines from Sciensano and the Belgian government. If the patient suffered from side effects from the cancer therapy, they received tips and tricks how to manage these complications. The collected data was forwarded to the patient medical file. As such health care workers were be able to use this information in the patients' follow up consultations.

ePROMs assessment

Jeroen Mebis, MD, PhD

During the COVID-19 pandemic, patients with cancer are subject to multiple risks (e.g. frequent hospital visits, increased infection risk, more severe clinical course, discontinued cancer treatment etc.).

Patients undergoing cancer therapy are also faced with several Quality of Life - impairing side effects. In the case of a positive COVID-19 cancer patient, the need and intensity of treating must be weighed against the possible higher risk of developing severe complications in the course of a COVID-19 infection. Nevertheless, both for COVID-19 positive and negative patients who will continue or discontinue cancer treatment throughout the pandemic, providing supportive care is more important than ever.

Digitally monitoring patient-reported outcome measures (PROMs) could offer a solution to improve the supportive care measures during cancer treatment, and certainly in times of COVID-19. Digitalized PROMS could significantly contribute to improved communication, patient satisfaction, supportive care, monitoring of cancer treatment, and detection of problems.

To date, clinical trials investigating the benefits of digital PROMS in patients with cancer during the current COVID-19 pandemic are lacking.

At the Jessa Hospital, the investigators already have experience in collecting PROMs via a digital platform (Awell Health) since 2019 for patients with breast cancer undergoing chemotherapy using validated QoL questionnaires.

The overall aim of this project is to prospectively evaluate the impact of a COVID-19 infection on the severity of the cancer therapy-related complications and the QoL of patients with cancer undergoing chemotherapy using a digital PROMs-platform.

General aim: The overall aim of this project is to prospectively evaluate the impact of a COVID-19 infection on the severity of the cancer therapy-related complications and the QoL of patients with cancer undergoing chemotherapy using a digital PROMs platform.

Objective 1: Evaluate the effect of a COVID-19 infection on the severity of cancer therapy-related side effects and patients' QoL

Rationale: The functionality of this platform will be based on three main principles:

1. The digital PROMs platform will provide patient-tailored information throughout the course of their disease and up to one month after the end of their chemotherapy concerning complications and COVID-19. This will support the cancer patients during their disease with specific advice based on the side effects they document. First, this will help comfort patients and reduce their anxiety and insecurity in these stressful times. Second, they will receive information regarding measures they can take to tackle their specific complications. Third, this will encourage patients to seek help in case of a possible COVID-19 infection and/or severe side effects by contacting the oncological support team or their physician.
2. The platform will prospectively collect QoL data using validated patient-reported questionnaires and specific COVID-19 questionnaires via a mobile application.
3. The platform will be fully integrated into the electronic health record (EHR) of the patient and will provide a structured report of the questioned complications for the physician. This will allow the medical oncologist to monitor the medical journey of the patient during and up to one month after their chemotherapy. As such, the medical oncologist can finetune the cancer treatment and supportive care measures towards the needs of the patient.

Hypothesis: "An COVID-19 infection will aggravate the severity of the cancer therapy-related complications and thereby diminish the patients' QoL."

Objective 2: Evaluate the patient benefit of digital PROMS platform Rationale: The implementation of a digital PROMs platform for cancer patients has demonstrated multiple benefits in the past, ranging from enhanced patient satisfaction, detection of unrecognized problems, earlier detection of complications, and/or more specific supportive care measures leading to an improved treatment outcome and QoL.

Hypothesis: "The use of a digital PROMs platform for cancer patients undergoing chemotherapy during the COVID-19 pandemic will lead to (1) an improved patient satisfaction and general knowledge on the oncologic supportive care measures and (2) a reduction in patient distress and anxiety".

General approach (for both objectives): A prospective, cohort study will be set up in patients with cancer undergoing chemotherapy. Patients will be stratified during treatment in two groups: (1) COVID-19 positive and (2) negative patients. Patients will be instructed to fill in validated Qol, distress/anxiety, and COVID-19 specific questionnaires via a digital platform from the day of inclusion up to 1-month post-chemotherapy.

An Integrated Digital PROM-platform for Cancer Patients During the COVID-19 Pandemic

Questionnaire to evaluate the presence and severity of therapy-related side effects

Questionnaire to evaluate patients' health-related quality of life on five different levels

Questionnaire to screen patients for the possibility of a COVID-19 infection.

Questionnaire about symptom burden related to COVID-19

Questionnaire to capture the frequency of specific phobias and stress disorders relevant to COVID-19, including anxiety, depression, specific phobias, cognitive change, avoidance and compulsive behavior, physical symptoms and loss of social functioning

Questionnaire to evaluate their general satisfaction and the user friendliness of the digital platform and how it improved their supportive care

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Telerehabilitation and Tele-psychological Support in Cancer Patients eCAN JA	NCT06007001	Cancer	Telemedicine	18 Years - 75 Years	Sciensano
Home Telemonitoring for Patients With Lung Cancer	NCT01670539	Lung Cancer	HomMed Telemoni...	45 Years - 90 Years	West Virginia University
Telerehabilitation and Tele-psychological Support in Cancer Patients eCAN JA	NCT06007001	Cancer	Telemedicine	18 Years - 75 Years	Sciensano
Home Telemonitoring for Patients With Lung Cancer	NCT01670539	Lung Cancer	HomMed Telemoni...	45 Years - 90 Years	West Virginia University
Telerehabilitation and Tele-psychological Support in Cancer Patients eCAN JA	NCT06007001	Cancer	Telemedicine	18 Years - 75 Years	Sciensano
Telerehabilitation and Tele-psychological Support in Cancer Patients eCAN JA	NCT06007001	Cancer	Telemedicine	18 Years - 75 Years	Sciensano
Home Telemonitoring for Patients With Lung Cancer	NCT01670539	Lung Cancer	HomMed Telemoni...	45 Years - 90 Years	West Virginia University
Telemonitoring After Surgery to Preserve Limb Function in Optimizing Mobility in Cancer Survivors With Skeletal Metastases	NCT02715856	Bone Metastases Cancer Survivor Metastatic Mali...	Monitoring Devi... Physical Activi... Quality-of-Life... Questionnaire A... Standard Follow... Survey Administ...	18 Years -	M.D. Anderson Cancer Center
Effects of Telemonitoring in Quality of Life Amongst Cancer Patients	NCT06086990	Cancer Telemonitoring Telemedicine Symptoms and Si... Quality of Life	Contigo Applica...	18 Years -	Universidad Nacional Andres Bello
Telemonitoring Platforms and Chemotherapy-Associated Toxicity	NCT06077123	Cancer Chemotherapeuti...	Contigo Applica...	18 Years -	Universidad Nacional Andres Bello
An Integrated Digital PROM-platform for Cancer Patients During the COVID-19 Pandemic	NCT04816656	Covid19 Oncology PROMs Chemotherapeuti...	ePROMs assessme...	18 Years -	Jessa Hospital

Spots Global Cancer Trial Database for telemonitoring