Patients will be provided with a Global System for Mobile communications (GSM) accelerometer-equipped Android smartphone (specific model to be decided) with an installed open source, freely available pedometer application (Google Fit, Google, CA, United States) which will record their daily steps. Patients will receive daily calls from a research assistant to document the presence of clinically significant chemotherapy-related toxicity.

Patients will be instructed to carry the smartphone around their hips during waking hours, regardless of whether they are at home or outside (a nylon hip holster will be provided) and to keep it turned on at all times.

Daily steps will be recorded for at least seven days before the start of chemotherapy, and the median baseline number of daily steps will be calculated for each patient.

On the first day of chemotherapy, patients will receive side effect education as per standard of care. Patients will be instructed to continue carrying the smartphone daily as indicated for the entire duration of the first three chemotherapy cycles.

At the end of the follow-up period (or sooner in cases of early interruption of chemotherapy due to toxicity or disease progression; a change in chemotherapy regimen; or hospitalizations lasting ≥3 days), patients will rate their satisfaction with the intervention using a Likert-scale questionnaire and open-ended questions.

Remote monitoring using smartphone accelerometer

Enrique Soto Pérez de Celis, MD,MSc

Patients with cancer in developing countries face considerable challenges in obtaining access to care due to a lack of human resources and infrastructure. This is particularly pressing for vulnerable populations such as older adults. In this setting, many patients receiving chemotherapy are unable to report the presence of toxicities, and adverse events can go unnoticed for considerable amounts of time. The goal of this study is to assess the accuracy of an objective patient-centered measure of physical function (the number of steps taken per day measured using an accelerometer-equipped smartphone) for the remote detection of chemotherapy toxicity in older adults. This study builds on a pilot trial showing that monitoring older patients remotely utilizing an accelerometer-equipped smartphone is feasible and acceptable, and that a decline in the number of steps detected using the device can be an early sign of chemotherapy toxicity. The hypothesis of this study is that a decline in the number daily steps from a prechemotherapy baseline, measured using an accelerometer-equipped smartphone, will be accurate for detecting chemotherapy toxicity in older adults with cancer. This study will evaluate the ability of a patient-centered measure (a decline in the number of daily steps compared with a pre-chemotherapy baseline) to identify the presence of clinically-significant chemotherapy-related toxicity in Mexican older adults with cancer starting first line chemotherapy. Patients will be provided with an accelerometer-equipped smartphone with an installed pedometer application. Baseline steps per day will be obtained and recorded before starting chemotherapy. The patients' steps will be monitored daily for the first three chemotherapy cycles and compared with baseline recordings. Patients will be contacted daily and chemotherapy toxicity will be assessed by a physician. If significant toxicities are identified, the patient will be prompted to seek medical attention. The optimal cutoff point for detecting chemotherapy toxicity utilizing a decline in the number of daily steps will be chosen and validated. The adherence and satisfaction with the intervention will also be evaluated. This study could improve current methods and transform the way in which cancer care is delivered by demonstrating that a simple patient-centered measure obtained using a commercially available smartphone can aid in the accurate identification of clinically significant toxicities among a vulnerable population such as older adults with cancer.

Accuracy of a Mobile Sensor-Based System for the Detection of Chemotherapy Toxicity in Older Adults With Cancer in a Developing Country

We will determine the diagnostic accuracy of percent decline in daily steps (index test) for detecting patient (pt) reported chemotherapy (CT) toxicity (Tox) (reference standard) using the area under the curve (AUC) of the receiver operating characteristic (ROC) curve.

Ratio of the number of days steps are uploaded (X) to the number of days (N) the pt was asked to carry the phone, reported as a percentage (X/N x100).

Percentage of pts reporting a high satisfaction with their experience carrying the smartphone

Conquer Cancer Foundation

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

patients downloading and using the CHATBOT

Patients benefiting from chemotherapy with outpatient follow-up (conventional follow-up by telephone calls) have the possibility to receive a weekly remote questionnaire (by email or SMS) via a CHATBOT on any terminal. This automated questionnaire collects data (completed by the patient and/or their caregivers) on tolerance and compliance to the care plan.

CHATBOT use

Antoine PIAU, MD PhD

Antoine PIAU, MD

The main objective of this pilot study is to evaluate the acceptability of clinical data collection using a semi-automated e-solution based on the use of text messaging among older adults undergoing chemotherapy treatment at home.

Most cancer diagnosis are made among the 70 years and over population. In this population, negative consequences of cancer treatments are of great concern, especially for those who are socially isolated or live in rural areas. International oncology societies recommend personalized treatments to reduce adverse events. However, few tools have been validated in this population to monitor compliance and risks of outpatient treatments. In addition, health professionals continue to manage unplanned patient calls which could disrupt effectiveness of their work. Our hypothesis is that the semi-automated collection of health data (text message questionnaires) during outpatient chemotherapy secures the patient's care pathway and optimizes care time, in particular for patients' education and support. Therefore, patients (and/or their caregivers) who benefit from calls follow-up (usual care), would have the possibility of receiving an additional weekly remote questionnaire (by email or SMS) via a CHATBOT on any terminal. This automated questionnaire collects data on tolerance and compliance with care plan.

E-Care Acceptability for Older People Undergoing Chemotherapy

Evaluate E-Care Acceptability for Older People Undergoing Chemotherapy at Home

Proportion of patients who uploaded the application, Proportion of patients who received at least one questionnaire, Proportion of patients who answered at least one questionnaire, Completion questionnaire rate and answered questionnaire rate

University Hospital, Toulouse

The control phase will run for 8 weeks, including survey completion and accelerometer wear during Week 1 and Week 8. The intervention phase will run for the 9 weeks following the control phase; where participants are assigned a smartphone to interact with the Mila Blooms gaming app and integrated social network \& receive weekly supportive coaching phone calls from study staff for 8 weeks (Week 9 - Week 16) followed by accelerometer wear \& survey completion during the 9th and final week (Week 17).

Behavioral intervention will be administered to 30 adolescent childhood cancer survivors \& their parents (3 blocks of 10 survivor-parent(s) groups) who serve as their own controls. The intervention phase begins at Week 9 (immediately following the 8-week control phase) and runs for 9 weeks (Weeks 9 - 17). Adolescents are assigned a smartphone installed with the Mila Blooms app to use for the first 8 weeks (Weeks 9 - 16) of the intervention. The app integrates (1) tools for tracking health behaviors (e.g., diet, physical activity, etc.); (2) an avatar system to provide virtual rewards, and (3) a social network of users for support. As part of the intervention, adolescents will also receive weekly coaching phone calls from study staff to discuss areas of concern and to encourage goal-setting \& participation. During the 9th week (Week 17), participants complete one final survey \& accelerometer wear.

Mila Blooms

Bernard F. Fuemmeler, Ph.D., MPH

This study is focused on the development and pilot/feasibility testing of a smartphone application to promote a healthy diet, increase physical activity, and prevent weight gain in adolescent survivors of childhood cancer.

While successful advancements in treatment for childhood Acute Lymphoblastic Leukemia (ALL) have resulted in a growing cohort of survivors, these survivors are at risk for a number of long-term health problems. This study proposes to develop and conduct feasibility testing for a smartphone application that would deliver a health behavior intervention to this population.

A formative phase focused on intervention and software development will be followed by a pilot/feasibility test of the intervention. Participants in the intervention will receive a customized study-designed mobile phone app with a social networking component in which users will be able to support one another. They will also receive personal support from a health counselor to help set goals and discuss areas of concern.

Mila Blooms Intervention Study

Mila Blooms Intervention Study: An App for Promoting Physical Activity and Health Diet Among Adolescent Survivors of Childhood Cancer

Test the feasibility of the Mila Blooms intervention at changing diet, physical activity, body mass index (BMI), and social cognitive mediators of health behavior change.

National Cancer Institute (NCI)

Duke University

Behaviors and Mental Disorders

All Conditions

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Accuracy of a Mobile Sensor-Based System for the Detection of Chemotherapy Toxicity in Older Adults With Cancer in a Developing Country	NCT04040881	Cancer	Remote monitori...	65 Years -	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
E-Care Acceptability for Older People Undergoing Chemotherapy	NCT05408195	Cancer	CHATBOT use	70 Years -	University Hospital, Toulouse
E-Care Acceptability for Older People Undergoing Chemotherapy	NCT05408195	Cancer	CHATBOT use	70 Years -	University Hospital, Toulouse
Mila Blooms Intervention Study	NCT01473342	Childhood Cance...	Mila Blooms	12 Years - 19 Years	Duke University
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

Spots Global Cancer Trial Database for smartphones

Every month we try and update this database with for smartphones 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 smartphones

Every month we try and update this database with for smartphones 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 smartphones 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.