Clinical trial NCT05770869: mHealth ALIBIRD: A Digital Health Care Model
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracic Neoplasms
Keywords: Active Treatment
Lead sponsor: Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares
Sponsor class: OTHER
Collaborators: name: Hospital Infanta Sofia
name: Universidad Politecnica de Madrid
name: IMDEA Food
name: Instituto de Investigación en Ciencias de la Alimentación (CIAL)
First posted: 2023-03-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Usability and feasibility assesment
timeFrame: week 1 to 28
Secondary outcomes:
measure: Changes in Mediterranean Diet Serving Score (MDSS)
timeFrame: Week 1 to 28
measure: Changes in Quality of life ( European Quality of Life-5 Dimensions 5 Levels questionnaire,EQ-5D-5L) from baseline
timeFrame: Week 1 to 28
measure: Changes in physical activity (International Physical Activity Questionnaire,PAQ)
timeFrame: Week 1 to 28
measure: Changes in sleep (Pittsburg questionnaire)
timeFrame: Week 1 to 28
measure: 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)
timeFrame: Week 1 to 28
measure: Changes in toxicity (Patient-Reported Outcome version of the Common Terminology Criteria for Adverse Events, PRO-CTAE questionnaire)
timeFrame: week 1 to 28
measure: Changes is Hospital Anxiety and Depression Questionnaire (HADs) from baseline
timeFrame: Week 1 to 28
measure: Changes in Massachusetts General Hospital-Sexual Functioning Questionnaire (MGH-SFQ) from baseline
timeFrame: Week 1 to 28
measure: Changes is medication adherence (MMAS-8 questionnaire)
timeFrame: Week 1 to 28
measure: Changes in belief in medication (Beliefs about Medicines Questionnaire,BMQ)
timeFrame: Week 1 to 28
Other outcomes:
Locations:
city: San Sebastián De Los Reyes
country: Spain
facility: Servicio de Oncología. Hospital Infanta Sofía
state: Madrid
Study officials:
affiliation: Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares
name: María Sereno Moyano, Medicine
role: PRINCIPAL_INVESTIGATOR
References: