mHealth ALIBIRD: A Digital Health Care Model

Thoracic Neoplasms Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05770869
• Other study ID #: mHA
• Status: Completed
• Phase: N/A
• Start date: November 5, 2021
• Est. completion date: October 28, 2022

Study information

• Verified date: October 2023
• Source: Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 28, 2022
• Est. primary completion date: October 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Thoracic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Spain	Servicio de Oncología. Hospital Infanta Sofía	San Sebastián De Los Reyes	Madrid

Sponsors (5)

Lead Sponsor	Collaborator
Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares	Hospital Infanta Sofia, IMDEA Food, Instituto de Investigación en Ciencias de la Alimentación (CIAL), Universidad Politecnica de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usability and feasibility assesment	Changes in Satisfaction System Usability Scale (SUS)	week 1 to 28
Secondary	Changes in Mediterranean Diet Serving Score (MDSS)	Mediterranean adherence assesment	Week 1 to 28
Secondary	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
Secondary	Changes in physical activity (International Physical Activity Questionnaire,PAQ)	Physical activity assesment	Week 1 to 28
Secondary	Changes in sleep (Pittsburg questionnaire)	Sleep assesment	Week 1 to 28
Secondary	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
Secondary	Changes in toxicity (Patient-Reported Outcome version of the Common Terminology Criteria for Adverse Events, PRO-CTAE questionnaire)	Toxicity assesment	week 1 to 28
Secondary	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
Secondary	Changes in Massachusetts General Hospital-Sexual Functioning Questionnaire (MGH-SFQ) from baseline	Sexuality assesment	Week 1 to 28
Secondary	Changes is medication adherence (MMAS-8 questionnaire)	Medication adherence assesment	Week 1 to 28
Secondary	Changes in belief in medication (Beliefs about Medicines Questionnaire,BMQ)	Belief in medication assesment	Week 1 to 28