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

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.

Study Overview

• Status: Unknown
• Conditions: Quality of Life; Cancer; Symptoms and Signs; Chemotherapeutic Agent Toxicity
• Intervention / Treatment: Device: Mentora app

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mentora; Remote symptoms monitoring with mobile app	Device: Mentora app; Remote monitoring mobile app

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
% 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
Total attendance - retention rate/total withdraw from study (30 days)	Total attendance - retention rate/total withdraw from study (30 days)	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	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	1 month
Frequency of grade 3 and 4 adverse events	Number of grade 3 and 4 adverse events reported	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	1 month

Collaborators and Investigators

• Sponsor: Associacao de Investigacao de Cuidados de Suporte em Oncologia
• Investigators: Principal Investigator: Catarina Ribeiro, Associacao de Investigacao de Cuidados de Suporte em Oncologia

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2021
• Primary Completion (Anticipated): March 30, 2021
• Study Completion (Anticipated): April 30, 2021

Study Registration Dates

• First Submitted: September 12, 2020
• First Submitted That Met QC Criteria: September 27, 2020
• First Posted (Actual): October 1, 2020

Study Record Updates

• Last Update Posted (Actual): January 12, 2021
• Last Update Submitted That Met QC Criteria: January 10, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: quality of life; cancer; supportive care; symptoms; remote monitoring; cancer survivors; digital healthcare
• Other Study ID Numbers: 3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No