Mobile App for Symptoms Monitoring in Cancer Patients: a Pilot Study (NCT04572282) | Clinical Trial Compass
UnknownNot Applicable
Mobile App for Symptoms Monitoring in Cancer Patients: a Pilot Study
30 participantsStarted 2021-02-01
Plain-language 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.
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Compliance rates with the weekly reports or weekly symptom log on the app higher than 60%% (Acceptability of the MHapp)
Timeframe: 1 month
Trial details
NCT IDNCT04572282
SponsorAssociacao de Investigacao de Cuidados de Suporte em Oncologia