CancerNCT04572282
Mobile App for Symptoms Monitoring in Cancer Patients: a Pilot Study
A study testing Mentora app in people with Cancer and Symptoms and Signs, 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, Symptoms and Signs, Quality of Life
- 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
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2021to 30 Apr 2021
- Phase
- Interventional
- 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 of any primary tumor (solid or hematologic)
- in systemic oncologic treatments of any type (including but not limited to immunotherapy, chemotherapy and targeted therapies) expected to continue for at least 4 weeks after enrolment, except when single treatment with hormone therapy for prostate cancer or breast cancer
- fluent in written Portuguese
- with a personal mobile smartphone (android or iphone)
- 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 as per attending physician's evaluation
- Having a life expectancy < 3 months as determined by the attending oncologist ECOG performance status greater than 2
- Unable to read and comprehend written portuguese language
Trial locations and contacts
No sites are listed yet.
Filipa Silva contact
About this study
Official title: Single Arm Pilot Study on a Mobile App for Symptoms Monitoring in Cancer Patients on Active Treatments
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.
We will conduct a pilot study to explore the feasibility of a mobile app for remote symptom monitoring in cancer patients. Patients will be recruited in Portuguese hospitals and will be invited to test the app for one month. Patient experience and satisfaction will be assessed via a weekly survey.
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
This is a single cohort study on cancer patients to explore the feasibility of mobile app for symptom monitoring and inform future randomized clinical trials and implementation. Patients will be screened at oncology visits for inclusion criteria and will be invited to use a mobile app to monitor and track treatment side-effects.
We will recruit a minimum of 10 cancer patients under systemic anti-neoplasic treatment being followed in medical oncology departments in portuguese hospitals. between February 1st and March 30th.
Participants will be invited to register their treatment side effects and symptoms on a health app designed for this purpose.
The Mentora Health App include a PRO-CTCAE™ based tool (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.
- Being tested
- Mentora app
- Keywords
- cancer, quality of life, digital healthcare, remote monitoring, symptoms, supportive care, cancer survivors
- Medical subject headings
- Neoplasms, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mentora appDevice
Remote monitoring mobile app
| Study group | Role | What they receive |
|---|---|---|
| Mentora | Experimental | Remote symptoms monitoring with mobile app Receives: Device: Mentora app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance rates with the weekly reports or weekly symptom log on the app higher than 60%% (Acceptability of the MHapp)
acceptability of the MHapp, measured by adherence to self-reporting will be assessed at 1 month. The outcome will be considered positive if at least one of the 2 following criteria applies to more than 60% of participants enrolled: replies to 2 or more weekly reports OR at least one weekly log to the app.
Measured: 1 month
Secondary outcomes (6)
% of side effects and adverse events reported on medical appointments also registered in the MHapp
% of side effects and adverse events reported on medical appointments also registered in mh
Measured: 1 month
Total attendance - retention rate/total withdraw from study (30 days)
Total attendance - retention rate/total withdraw from study (30 days)
Measured: 1 month
Impact of MHapp on cancer QoL (EORTC quality of life c 30): comparison between baseline, and 1 month
Higher values after the 1 month intervention mean positive impact with increased quality of life
Measured: 1 month
Report healthcare resources use: number of unplanned hospital visits or calls; unplanned hospitalizations; time inside medical appointments
number of unplanned hospital visits or calls; unplanned hospitalizations; time inside medical appointments
Measured: 1 month
Frequency of grade 3 and 4 adverse events
Number of grade 3 and 4 adverse events reported
Measured: 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
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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start1 Feb 2021 (estimated)
- Primary completion30 Mar 2021 (estimated)
- Study completion30 Apr 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT04572282
- Sponsor's protocol ID
- 3
- Status last verified
- Sep 2020
- First submitted
- 12 Sep 2020
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Arm Pilot Study on a Mobile App for Symptoms Monitoring in Cancer Patients on Active Treatments
- ClinicalTrials.gov ID
- NCT04572282
- Acronym / sponsor ID
- 3
- Keywords
- cancer, quality of life, digital healthcare, remote monitoring, symptoms, supportive care, cancer survivors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Associacao de Investigacao de Cuidados de Suporte em OncologiaUniversity, hospital or other
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 30 Mar 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 1 Oct 2020 (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.
We will conduct a pilot study to explore the feasibility of a mobile app for remote symptom monitoring in cancer patients. Patients will be recruited in Portuguese hospitals and will be invited to test the app for one month. Patient experience and satisfaction will be assessed via a weekly survey.
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
This is a single cohort study on cancer patients to explore the feasibility of mobile app for symptom monitoring and inform future randomized clinical trials and implementation. Patients will be screened at oncology visits for inclusion criteria and will be invited to use a mobile app to monitor and track treatment side-effects.
We will recruit a minimum of 10 cancer patients under systemic anti-neoplasic treatment being followed in medical oncology departments in portuguese hospitals. between February 1st and March 30th.
Participants will be invited to register their treatment side effects and symptoms on a health app designed for this purpose.
The Mentora Health App include a PRO-CTCAE™ based tool (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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mentora | Experimental | Device: Mentora appRemote symptoms monitoring with mobile app |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- adults (18 years old or older)
- with a cancer diagnosis at any stage of any primary tumor (solid or hematologic)
- in systemic oncologic treatments of any type (including but not limited to immunotherapy, chemotherapy and targeted therapies) expected to continue for at least 4 weeks after enrolment, except when single treatment with hormone therapy for prostate cancer or breast cancer
- fluent in written Portuguese
- with a personal mobile smartphone (android or iphone)
Key exclusion criteria (3 listed)
- Cognitive impairment or disability that limits capacity to comply with study interventions and assessments as per attending physician's evaluation
- Having a life expectancy < 3 months as determined by the attending oncologist ECOG performance status greater than 2
- Unable to read and comprehend written portuguese language
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 appRemote monitoring mobile app | Device | Mentora |
Primary outcome
Compliance rates with the weekly reports or weekly symptom log on the app higher than 60%% (Acceptability of the MHapp)
Time frame: 1 month
acceptability of the MHapp, measured by adherence to self-reporting will be assessed at 1 month. The outcome will be considered positive if at least one of the 2 following criteria applies to more than 60% of participants enrolled: replies to 2 or more weekly reports OR at least one weekly log to the app.
6 secondary outcomes
% of side effects and adverse events reported on medical appointments also registered in the MHapp
Time frame: 1 month
Total attendance - retention rate/total withdraw from study (30 days)
Time frame: 1 month
Impact of MHapp on cancer QoL (EORTC quality of life c 30): comparison between baseline, and 1 month
Time frame: 1 month
Report healthcare resources use: number of unplanned hospital visits or calls; unplanned hospitalizations; time inside medical appointments
Time frame: 1 month
Frequency of grade 3 and 4 adverse events
Time frame: 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
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
Filipa Silva contact
Catarina Ribeiro principal investigator
Associacao de Investigacao de Cuidados de Suporte em Oncologia
Questions about this trial
What is this clinical trial studying?
A study testing Mentora app in people with Cancer and Symptoms and Signs, 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 6 inclusion and 3 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 12 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.
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, MD, MSc (+351962079292, catarinaribeiroa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance rates with the weekly reports or weekly symptom log on the app higher than 60%% (Acceptability 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 12 Jan 2021.