Clinical trial NCT04710472: MentorApp for Cancer Patient's Remote Monitoring
Official title: Randomized Controlled Trial of a Mobile App for Remote Patient Monitoring in Oncology: a Phase II Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cancer
Keywords: cancer
supportive care
digital healthcare
remote monitoring
symptoms
quality of life
Lead sponsor: Associacao de Investigacao de Cuidados de Suporte em Oncologia
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: feasibility and usability of the MHapp
timeFrame: 1 month
Secondary outcomes:
measure: To evaluate the impact of MHapp on cancer patients QoL on European Organisation for Research and Treatment of Cancer.(EORTC) Core (c)30
timeFrame: 1 and 3 months
measure: To explore the satisfaction of cancer patients, clinical teams and their carers with the MHapp
timeFrame: 1 week, 1 month, 3 months
measure: To understand how to improve users' experience navigating the MHapp
timeFrame: 1 week, 1 month, 3 months
measure: To report adherence rates to the app usage at 1 and 3 months on the intervention arm
timeFrame: 1 month, 3 months
measure: To compare healthcare resources use in both study arms
timeFrame: 1 month, 3 months
measure: To evaluate the impact on AEs G>2 per CTCAE (Common Terminology Criteria for Adverse Events) v.5 (minimum 1 maximum 4)
timeFrame: 1 and 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Associacao de Investigacao de Cuidados de Suporte em Oncologia
name: Catarina Ribeiro
role: PRINCIPAL_INVESTIGATOR
References: