Mobile App for Symptoms Monitoring in Cancer Patients: a Pilot Study

Study Overview
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Brief Summary
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With the growing number of cancer survivors, challenges to deal with comorbidities and impacted quality of life of cancer survivors by the disease and treatments also surge. Symptoms and Adverse Events are common and insufficiently monitored in real time / real life, which leads to increased symptom burden, treatment delays and unplanned hospital admissions. Remote monitoring apps have been shown to improve quality of life, symptom control and survival in published clinical trials, but no data with such interventions exists on the Portuguese population. We will conduct a pilot study to explore the feasibility of a mobile app for remote symptom monitoring in cancer patients. Patients will be recruited in Portuguese hospitals and will be invited to test the app for one month. Patient experience and satisfaction will be assessed via a weekly survey. The results of this pilot study will inform subsequent randomized clinical trials to test safety and efficacy of remote monitoring and lifestyle interventions to improve symptoms control and quality of life.

Detailed Description
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This is a single cohort study on cancer patients to explore the feasibility of mobile app for symptom monitoring and inform future randomized clinical trials and implementation. Patients will be screened at oncology visits for inclusion criteria and will be invited to use a mobile app to monitor and track treatment side-effects. We will recruit a minimum of 10 cancer patients under systemic anti-neoplasic treatment being followed in medical oncology departments in portuguese hospitals. between February 1st and March 30th. Participants will be invited to register their treatment side effects and symptoms on a health app designed for this purpose. The Mentora Health App include a PRO-CTCAE™ based tool (a patient-reported outcome measurement system developed by the National Cancer Institute), version 1.1, that includes 80 symptoms (attachment 1) and has been translated and validated to Portuguese (Portugal) by the authoring entity. These symptoms are graded on a five-point scale from 0 (not present) to 4 (disabling) based on clinical criteria.

Official Title
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Single Arm Pilot Study on a Mobile App for Symptoms Monitoring in Cancer Patients on Active Treatments

Conditions
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Cancer, Symptoms and Signs, Quality of Life, Chemotherapeutic Agent Toxicity

Intervention / Treatment
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* Device: Mentora app


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults (18 years old or older) with a cancer diagnosis at any stage of any primary tumor (solid or hematologic) in systemic oncologic treatments of any type (including but not limited to immunotherapy, chemotherapy and targeted therapies) expected to continue for at least 4 weeks after enrolment, except when single treatment with hormone therapy for prostate cancer or breast cancer fluent in written Portuguese with a personal mobile smartphone (android or iphone) willing to give informed consent for study participation Exclusion criteria: Cognitive impairment or disability that limits capacity to comply with study interventions and assessments as per attending physician's evaluation Having a life expectancy < 3 months as determined by the attending oncologist ECOG performance status greater than 2 Unable to read and comprehend written portuguese language

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mentora<br>Remote symptoms monitoring with mobile app | Device: Mentora app<br>* Remote monitoring mobile app<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance rates with the weekly reports or weekly symptom log on the app higher than 60%% (Acceptability of the MHapp) | acceptability of the MHapp, measured by adherence to self-reporting will be assessed at 1 month. The outcome will be considered positive if at least one of the 2 following criteria applies to more than 60% of participants enrolled: replies to 2 or more weekly reports OR at least one weekly log to the app. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of side effects and adverse events reported on medical appointments also registered in the MHapp | % of side effects and adverse events reported on medical appointments also registered in mh | 1 month | 
| Total attendance - retention rate/total withdraw from study (30 days) | Total attendance - retention rate/total withdraw from study (30 days) | 1 month | 
| Impact of MHapp on cancer QoL (EORTC quality of life c 30): comparison between baseline, and 1 month | Higher values after the 1 month intervention mean positive impact with increased quality of life | 1 month | 
| Report healthcare resources use: number of unplanned hospital visits or calls; unplanned hospitalizations; time inside medical appointments | number of unplanned hospital visits or calls; unplanned hospitalizations; time inside medical appointments | 1 month | 
| Frequency of grade 3 and 4 adverse events | Number of grade 3 and 4 adverse events reported | 1 month | 
| Satisfaction of clinical oncology doctors and nurses with the information report provided by the MHapp on a Likert scale from 0 (not satisfied at all) to 7 (Very satisfied) and through qualitative analysis of open ended questions | Satisfaction of clinical oncology doctors and nurses with the information report provided by the MHapp on a Likert scale from 0 (not satisfied at all) to 7 (Very satisfied) and through qualitative analysis of open ended questions | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, quality of life, digital healthcare, remote monitoring, symptoms, supportive care, cancer survivors