MentorApp for Cancer Patient's Remote Monitoring

NCT ID: NCT04710472

Last Updated: 2021-01-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2021-08-31

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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

MH

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

Group Type: EXPERIMENTAL

Mentora App

Intervention Type: DEVICE

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.

C

SOC

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Associacao de Investigacao de Cuidados de Suporte em Oncologia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catarina Ribeiro

Role: PRINCIPAL_INVESTIGATOR

Associacao de Investigacao de Cuidados de Suporte em Oncologia

Central Contacts

Catarina Ribeiro

Role: CONTACT

catarinaribeiroa@gmail.com

+351962079292

Other Identifiers

AICSO3

Identifier Type: -

Identifier Source: org_study_id