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

NCT04572282 | Unknown

• 1 other identifier: 3
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• % of side effects and adverse events reported on medical appointments also registered in the MHapp

  1 month

• 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

  1 month

• Report healthcare resources use: number of unplanned hospital visits or calls; unplanned hospitalizations; time inside medical appointments

  1 month

• Frequency of grade 3 and 4 adverse events

  1 month

Study Arms (1)

Mentora

EXPERIMENTAL

Remote symptoms monitoring with mobile app

Device: Mentora app

Interventions

Mentora app DEVICE

Remote monitoring mobile app

Mentora

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Associacao de Investigacao de Cuidados de Suporte em Oncologia: lead

MeSH Terms

Conditions

Neoplasms; Signs and Symptoms

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Study Officials

• Catarina Ribeiro

  Associacao de Investigacao de Cuidados de Suporte em Oncologia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catarina Ribeiro, MD, MSc

CONTACT

+351962079292; catarinaribeiroa@gmail.com

Filipa Silva

CONTACT

filipanfs@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2020
• First Posted: October 1, 2020
• Study Start: February 1, 2021
• Primary Completion: March 30, 2021
• Study Completion: April 30, 2021
• Last Updated: January 12, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share