Clinical trial NCT04572282: Mobile App for Symptoms Monitoring in Cancer Patients: a Pilot Study
Official title: Single Arm Pilot Study on a Mobile App for Symptoms Monitoring in Cancer Patients on Active Treatments
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Symptoms and Signs
Quality of Life
Chemotherapeutic Agent Toxicity
Keywords: cancer
quality of life
digital healthcare
remote monitoring
symptoms
supportive care
cancer survivors
Lead sponsor: Associacao de Investigacao de Cuidados de Suporte em Oncologia
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Compliance rates with the weekly reports or weekly symptom log on the app higher than 60%% (Acceptability of the MHapp)
timeFrame: 1 month
Secondary outcomes:
measure: % of side effects and adverse events reported on medical appointments also registered in the MHapp
timeFrame: 1 month
measure: Total attendance - retention rate/total withdraw from study (30 days)
timeFrame: 1 month
measure: Impact of MHapp on cancer QoL (EORTC quality of life c 30): comparison between baseline, and 1 month
timeFrame: 1 month
measure: Report healthcare resources use: number of unplanned hospital visits or calls; unplanned hospitalizations; time inside medical appointments
timeFrame: 1 month
measure: Frequency of grade 3 and 4 adverse events
timeFrame: 1 month
measure: 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
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Associacao de Investigacao de Cuidados de Suporte em Oncologia
name: Catarina Ribeiro
role: PRINCIPAL_INVESTIGATOR
References: