CancerPhase 2MentorA1NCT04710472
MentorApp for Cancer Patient's Remote Monitoring
A Phase 2 study testing Mentora App in people with Cancer, run by Associacao de Investigacao de Cuidados de Suporte em Oncologia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Mentora App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to 31 Aug 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Being tested
- Mentora App
- Keywords
- cancer, supportive care, digital healthcare, remote monitoring, symptoms, quality of life
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mentora AppDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| MH | Experimental | Arm MH - mobile Mentora app to monitor and track treatment side-effects, vital signs, therapeutics and daily habits; Receives: Device: Mentora App |
| C | No intervention | SOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (6)
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
Measured: 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
Measured: 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;
Measured: 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)
Measured: 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.
Measured: 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
Measured: 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start1 Mar 2021 (estimated)
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Associacao de Investigacao de Cuidados de Suporte em Oncologia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catarina Ribeiro, Principal investigator, Associacao de Investigacao de Cuidados de Suporte em Oncologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710472
- Sponsor's protocol ID
- AICSO3
- Acronym
- MentorA1
- Status last verified
- Jan 2021
- First submitted
- 10 Jan 2021
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of a Mobile App for Remote Patient Monitoring in Oncology: a Phase II Trial
- ClinicalTrials.gov ID
- NCT04710472
- Acronym / sponsor ID
- MentorA1 / AICSO3
- Conditions
- Cancer
- Keywords
- cancer, supportive care, digital healthcare, remote monitoring, symptoms, quality of life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Associacao de Investigacao de Cuidados de Suporte em OncologiaUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 14 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MH | Experimental | Device: Mentora AppArm MH - mobile Mentora app to monitor and track treatment side-effects, vital signs, therapeutics and daily habits; |
| C | No intervention | –SOC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mentora AppParticipants 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. | Device | MH |
Primary outcome
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.
6 secondary outcomes
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
To explore the satisfaction of cancer patients, clinical teams and their carers with the MHapp
Time frame: 1 week, 1 month, 3 months
To understand how to improve users' experience navigating the MHapp
Time frame: 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
To compare healthcare resources use in both study arms
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catarina Ribeiro principal investigator
Associacao de Investigacao de Cuidados de Suporte em Oncologia
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mentora App in people with Cancer, run by Associacao de Investigacao de Cuidados de Suporte em Oncologia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catarina Ribeiro (+351962079292, catarinaribeiroa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feasibility and usability of the MHapp (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2021.