- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04710472
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
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
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Catarina Ribeiro
- Phone Number: +351962079292
- Email: catarinaribeiroa@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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;
|
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
Time Frame: 1 month
|
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
Time Frame: 1 and 3 months
|
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
Time Frame: 1 week, 1 month, 3 months
|
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
Time Frame: 1 week, 1 month, 3 months
|
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
Time Frame: 1 month, 3 months
|
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
Time Frame: 1 month, 3 months
|
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)
Time Frame: 1 and 3 months
|
Frequency of G>2 AEs
|
1 and 3 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Catarina Ribeiro, Associacao de Investigacao de Cuidados de Suporte em Oncologia
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AICSO3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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