mHealth ALIBIRD: A Digital Health Care Model

mHealth ALIBIRD: A Digital Health Care Model (Analysis of the Applicability of an m-Health Platform and Its Impact on the Follow-up of Patients With Cancer: Pilot Study in a Sample of Patients With Advanced Non-small Cell Carcinoma)

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.

Study Overview

• Status: Completed
• Conditions: Thoracic Neoplasms
• Intervention / Treatment: Device: ALIBIRD mHealth platform

Detailed Description

The investigators have developed an innovative mHealth platform that provides personalized recommendations based on Patient Reported Outcomes (PROs) records and the study of patient´s nutrigenomics and gut microbiome. The usability of the ALIBIRD mHealth platform prototype is being tested in a 28-week pilot study carried out at Infanta Sofía Hospital. A small group of stage IV thoracic neoplasms patients (n=20) were asked to participate. All the participants gave informed consent.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • San Sebastián De Los Reyes, Madrid, Spain, 28134
      • Servicio de Oncología. Hospital Infanta Sofía

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• 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: ALIBIRD mHealth platform; 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; Use of a mHealth platform to follow-up and empower cancer patients in the self-management of their own health.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability and feasibility assesment	Changes in Satisfaction System Usability Scale (SUS)	week 1 to 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Mediterranean Diet Serving Score (MDSS)	Mediterranean adherence assesment	Week 1 to 28
Changes in physical activity (International Physical Activity Questionnaire,PAQ)	Physical activity assesment	Week 1 to 28
Changes in sleep (Pittsburg questionnaire)	Sleep assesment	Week 1 to 28
Changes in toxicity (Patient-Reported Outcome version of the Common Terminology Criteria for Adverse Events, PRO-CTAE questionnaire)	Toxicity assesment	week 1 to 28
Changes in Massachusetts General Hospital-Sexual Functioning Questionnaire (MGH-SFQ) from baseline	Sexuality assesment	Week 1 to 28
Changes is medication adherence (MMAS-8 questionnaire)	Medication adherence assesment	Week 1 to 28
Changes in belief in medication (Beliefs about Medicines Questionnaire,BMQ)	Belief in medication assesment	Week 1 to 28
Changes in Quality of life ( European Quality of Life-5 Dimensions 5 Levels questionnaire,EQ-5D-5L) from baseline	Quality of life assesment. The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. In the VAS the individual scores his or her health between two extremes, 0 and 100, the worst and best state of health imaginable.	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)	Quality of life assesment. The LC13 covers 13 typical symptoms of lung cancer patients, such as coughing, pain, dyspnea, sore mouth, peripheral neuropathy, and hair loss. questions along 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning) and nine symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) All items are scored from 1 to 4 in relation to the presence of the symptom: not at all, a little, quite a bit, very much.	Week 1 to 28
Changes is Hospital Anxiety and Depression Questionnaire (HADs) from baseline	Emotional status assesment. This is a scale containing two subscales with 7 anxiety symptoms (HADS-A) and 7 depression symptoms (HADS-D). The items are scored on a 4-point Likert frequency scale (0-3) with a total score ranging from 0 to 21 for each subscale, where a higher score is indicative of greater symptom severity.	Week 1 to 28

Collaborators and Investigators

• Sponsor: Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares
• Collaborators: Universidad Politecnica de Madrid; IMDEA Food; Hospital Infanta Sofia; Instituto de Investigación en Ciencias de la Alimentación (CIAL)
• Investigators: Principal Investigator: María Sereno Moyano, Medicine, Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2021
• Primary Completion (Actual): October 28, 2022
• Study Completion (Actual): October 28, 2022

Study Registration Dates

• First Submitted: January 24, 2023
• First Submitted That Met QC Criteria: March 14, 2023
• First Posted (Actual): March 16, 2023

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Active Treatment
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Thoracic Neoplasms
• Other Study ID Numbers: mHA

Drug and device information, study documents

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