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

NCT ID: NCT04572282

Last Updated: 2021-01-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2021-04-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Mentora

Remote symptoms monitoring with mobile app

Group Type: EXPERIMENTAL

Mentora app

Intervention Type: DEVICE

Remote monitoring mobile app

Interventions

Mentora app

Remote monitoring mobile app

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Associacao de Investigacao de Cuidados de Suporte em Oncologia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catarina Ribeiro

Role: PRINCIPAL_INVESTIGATOR

Associacao de Investigacao de Cuidados de Suporte em Oncologia

Central Contacts

Catarina Ribeiro, MD, MSc

Role: CONTACT

catarinaribeiroa@gmail.com

+351962079292

Filipa Silva

Role: CONTACT

filipanfs@gmail.com

Other Identifiers

3

Identifier Type: -

Identifier Source: org_study_id