NCT04710472

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. A phase II randomized controlled trial to explore the feasibility of a mobile app for remote symptom monitoring in cancer patients will be done. Patients will be recruited in Portuguese Hospitals and will be invited to test the app for three months. Patient experience and satisfaction will be assessed via a weekly survey. Quality of life will be assessed at 1 and 3 months. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2 cancer

Timeline
Completed

Started Mar 2021

Shorter than P25 for phase_2 cancer

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

January 14, 2021

Status Verified

January 1, 2021

Enrollment Period

6 months

First QC Date

January 10, 2021

Last Update Submit

January 13, 2021

Conditions

Cancer

Keywords

cancersupportive caredigital healthcareremote monitoringsymptomsquality of life

Outcome Measures

Primary Outcomes (1)

  • feasibility and usability of the MHapp

    The outcome will be considered positive if at least one of the 2 following criteria applies to more than 60 percent of participants enrolled: replies to 2 or more weekly reports OR at least one weekly log in to the app.

    1 month

Secondary Outcomes (6)

  • To evaluate the impact of MHapp on cancer patients QoL on European Organisation for Research and Treatment of Cancer.(EORTC) Core (c)30

    1 and 3 months

  • To explore the satisfaction of cancer patients, clinical teams and their carers with the MHapp

    1 week, 1 month, 3 months

  • To understand how to improve users' experience navigating the MHapp

    1 week, 1 month, 3 months

  • To report adherence rates to the app usage at 1 and 3 months on the intervention arm

    1 month, 3 months

  • To compare healthcare resources use in both study arms

    1 month, 3 months

  • +1 more secondary outcomes

Study Arms (2)

MH

EXPERIMENTAL

Arm MH - mobile Mentora app to monitor and track treatment side-effects, vital signs, therapeutics and daily habits;

Device: Mentora App

C

NO INTERVENTION

SOC

Interventions

Mentora AppDEVICE

Participants will be invited to register their treatment side effects, symptoms, daily activities and exercise and QoL on a health app designed for this purpose. The Mentora Health App includes a tool based on PRO-CTCAE™, 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.

MH

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults (18 years old or older)
  • with a cancer diagnosis at any stage
  • Receiving systemic chemotherapy not in the context of a clinical trial, with treatment
  • expected to continue for at least three months counting from time of enrollment
  • fluent in written Portuguese
  • with a personal mobile smartphone (android or iphone any version)
  • 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
  • Having a life expectancy \< 3 months as determined by the attending oncologist
  • ECOG performance status greater than 2
  • Unable to read and comprehend portuguese language text

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Catarina Ribeiro

    Associacao de Investigacao de Cuidados de Suporte em Oncologia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Catarina Ribeiro

CONTACT

+351962079292catarinaribeiroa@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2021

First Posted

January 14, 2021

Study Start

March 1, 2021

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

January 14, 2021

Record last verified: 2021-01