NCT05770869

Brief Summary

The aim of this pilot study was to evaluate the feasibility and acceptability of the ALIBIRD platform, a new mobile health (mHealth) application prototype design for personalized and remote support on the follow-up of cancer patients. The ALIBIRD platform is a mHealth intervention that tracks PROs, improving symptom control and allowing real-time feedback, and provides personalized recommendations and educational content, promoting empowerment and encourage healthy lifestyle behaviors in patients with thoracic neoplasms in active treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 5, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 16, 2023

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

12 months

First QC Date

January 24, 2023

Last Update Submit

October 17, 2023

Conditions

Thoracic Neoplasms

Keywords

Active Treatment

Outcome Measures

Primary Outcomes (1)

  • Usability and feasibility assesment

    Changes in Satisfaction System Usability Scale (SUS)

    week 1 to 28

Secondary Outcomes (10)

  • Changes in Mediterranean Diet Serving Score (MDSS)

    Week 1 to 28

  • Changes in Quality of life ( European Quality of Life-5 Dimensions 5 Levels questionnaire,EQ-5D-5L) from baseline

    Week 1 to 28

  • Changes in physical activity (International Physical Activity Questionnaire,PAQ)

    Week 1 to 28

  • Changes in sleep (Pittsburg questionnaire)

    Week 1 to 28

  • Changes in Quality of life ( The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13, EORTC QLQ-LC-13)

    Week 1 to 28

  • +5 more secondary outcomes

Study Arms (1)

ALIBIRD mHealth platform

EXPERIMENTAL

Participants are followed-up using the ALIBIRD mHealth platform. The ALIBIRD platform is made up of a mobile application for patients and a web application for the healthcare team. Through the ALIBIRD mobile application, patients regularly register Patients Reported Outcomes (PROs) and Patients Reported Outcome Measures (PROMs) regarding lifestyle (diet, physical activity, sleep, mood), and get access to individualized recommendations in order to assume more responsibility for achieving the best outcomes from their care. Moreover, the patient application includes features for tracking the appearance of symptoms, with alerts sent to the healthcare team in response to these parameters. In addition, the application contains articles and educational information.

Device: ALIBIRD mHealth platform

Interventions

ALIBIRD mHealth platformDEVICE

Use of a mHealth platform to follow-up and empower cancer patients in the self-management of their own health.

ALIBIRD mHealth platform

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with thoracic neoplasms, histologically or cytologically confirmed.
  • \< 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  • Patients receiving cancer treatment: chemotherapy, chemotherapy-immunotherapy, immunotherapy or biological therapy.
  • Patients with internet access and intermediate level in the use of technology (Smartphone, mobile applications, wearable)
  • Signed informed consent.

You may not qualify if:

  • Patients with symptomatic brain metastases.
  • Patients with neurological impairment, dementia or psychiatric disorders.
  • Patients unable to follow the protocol due to psychological, social or geographic reasons.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Servicio de Oncología. Hospital Infanta Sofía

San Sebastián de los Reyes, Madrid, 28134, Spain

Location

MeSH Terms

Conditions

Thoracic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • María Sereno Moyano, Medicine

    Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 24, 2023

First Posted

March 16, 2023

Study Start

November 5, 2021

Primary Completion

October 28, 2022

Study Completion

October 28, 2022

Last Updated

October 18, 2023

Record last verified: 2023-10

Locations

ES(1)