MentorApp for Cancer Patient's Remote Monitoring (MentorA1)

Randomized Controlled Trial of a Mobile App for Remote Patient Monitoring in Oncology: a Phase II Trial

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.

A phase II randomized controlled trial to explore the feasibility of a mobile app for remote symptom monitoring in cancer patients will be done. Patients will be recruited in Portuguese Hospitals and will be invited to test the app for three months. Patient experience and satisfaction will be assessed via a weekly survey. Quality of life will be assessed at 1 and 3 months.

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.

Study Overview

• Status: Unknown
• Conditions: Cancer
• Intervention / Treatment: Device: Mentora App

Detailed Description

The primary aim is to assess the feasibility and usability of a mobile app (MHapp) to remote register and monitor treatment side effects, lifestyle habits and clinical data in cancer patients.

This is a phase II randomized controlled trial with two study arms:

Arm MH - mobile Mentora app to monitor and track treatment side-effects, vital signs, therapeutics and daily habits; Arm C - SOC

No sham intervention is thought to be viable as we want to test the MHapp as a whole complex intervention with all different components and compare it with current SOC. Patients will be screened at oncology visits for inclusion criteria. It is not viable also to blind clinicians once the app provides a detailed progress report of which we want to assess the impact on oncology care and clinical team satisfaction. We will blind statisticians and people performing the final analysis.

Once agreeing to enrol, patients will be randomly allocated to one of the study arms through a computer generated sequence of numbers, concealed from the clinical staff and patients.

8.1 Study design and Population

Randomized controlled clinical trial with two arms - arm MH (intervention with the MH app) and arm C (controls - standard of care). We will recruit 50 cancer patients in systemic treatments in Portuguese hospitals with oncology service.

Inclusion criteria:

adults (18 years old or older) with a cancer diagnosis at any stage Receiving systemic chemotherapy not in the context of a clinical trial, with treatment expected to continue for at least three months counting from time of enrollment fluent in written Portuguese with a personal mobile smartphone (android or iphone any version) willing to give informed consent for study participation

Exclusion criteria:

Cognitive impairment or disability that limits capacity to comply with study interventions and assessments Having a life expectancy < 3 months as determined by the attending oncologist ECOG performance status greater than 2 Unable to read and comprehend portuguese language text Participants will remain on study until discontinuation of cancer treatment, voluntary withdrawal, or death.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• adults (18 years old or older)
• with a cancer diagnosis at any stage
• Receiving systemic chemotherapy not in the context of a clinical trial, with treatment
• expected to continue for at least three months counting from time of enrollment
• fluent in written Portuguese
• with a personal mobile smartphone (android or iphone any version)
• willing to give informed consent for study participation

Exclusion Criteria:

• Cognitive impairment or disability that limits capacity to comply with study interventions and assessments
• Having a life expectancy < 3 months as determined by the attending oncologist
• ECOG performance status greater than 2
• Unable to read and comprehend portuguese language text

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MH; Arm MH - mobile Mentora app to monitor and track treatment side-effects, vital signs, therapeutics and daily habits;	Device: Mentora App; Participants will be invited to register their treatment side effects, symptoms, daily activities and exercise and QoL on a health app designed for this purpose. The Mentora Health App includes a tool based on PRO-CTCAE™, 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.
No Intervention: C; SOC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
feasibility and usability of the MHapp	The outcome will be considered positive if at least one of the 2 following criteria applies to more than 60 percent of participants enrolled: replies to 2 or more weekly reports OR at least one weekly log in to the app.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the impact of MHapp on cancer patients QoL on European Organisation for Research and Treatment of Cancer.(EORTC) Core (c)30	Impact of MHapp on cancer Qol	1 and 3 months
To explore the satisfaction of cancer patients, clinical teams and their carers with the MHapp	Patient's satisfaction with the app will be documented via survey at 1 week, 1 month and 3 months from D1 and interview at 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 via interview at the end of the study period	1 week, 1 month, 3 months
To understand how to improve users' experience navigating the MHapp	General question about usability and ease of use will be asked on the survey done at 1 week, 1 month and 3 months from D1 and explored in further detail at the interview at 1 month;	1 week, 1 month, 3 months
To report adherence rates to the app usage at 1 and 3 months on the intervention arm	Percentage of side effects and adverse events reported on medical appointments also registered in the MHapp during the 1st month on study Total attendance - retention rate/total withdraw from study (30 days)	1 month, 3 months
To compare healthcare resources use in both study arms	Report healthcare resources use: number of unplanned hospital visits or calls; unplanned hospitalizations; time inside medical appointments.	1 month, 3 months
To evaluate the impact on AEs G>2 per CTCAE (Common Terminology Criteria for Adverse Events) v.5 (minimum 1 maximum 4)	Frequency of G>2 AEs	1 and 3 months

Collaborators and Investigators

• Sponsor: Associacao de Investigacao de Cuidados de Suporte em Oncologia
• Investigators: Principal Investigator: Catarina Ribeiro, Associacao de Investigacao de Cuidados de Suporte em Oncologia

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2021
• Primary Completion (Anticipated): August 31, 2021
• Study Completion (Anticipated): August 31, 2021

Study Registration Dates

• First Submitted: January 10, 2021
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 14, 2021

Study Record Updates

• Last Update Posted (Actual): January 14, 2021
• Last Update Submitted That Met QC Criteria: January 13, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: quality of life; cancer; supportive care; symptoms; remote monitoring; digital healthcare
• Other Study ID Numbers: AICSO3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No