Mobile App for Symptoms Monitoring in Cancer Patients: a Pilot Study

Cancer Clinical Trial

Official title:

Single Arm Pilot Study on a Mobile App for Symptoms Monitoring in Cancer Patients on Active Treatments

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04572282
• Other study ID #: 3
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: April 30, 2021

Study information

• Verified date: September 2020
• Source: Associacao de Investigacao de Cuidados de Suporte em Oncologia
• Contact: Catarina Ribeiro, MD, MSc
• Phone: +351962079292
• Email: catarinaribeiroa[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: April 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Chemotherapeutic Agent Toxicity
• Quality of Life
• Symptoms and Signs

Intervention

Device:
• Mentora app
Remote monitoring mobile app

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Associacao de Investigacao de Cuidados de Suporte em Oncologia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month
Secondary	% 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	1 month
Secondary	Total attendance - retention rate/total withdraw from study (30 days)	Total attendance - retention rate/total withdraw from study (30 days)	1 month
Secondary	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	1 month
Secondary	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	1 month
Secondary	Frequency of grade 3 and 4 adverse events	Number of grade 3 and 4 adverse events reported	1 month
Secondary	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	1 month