search
Back to results

mHealth ALIBIRD: A Digital Health Care Model

Primary Purpose

Thoracic Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
ALIBIRD mHealth platform
Sponsored by
Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Thoracic Neoplasms focused on measuring Active Treatment

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Servicio de Oncología. Hospital Infanta Sofía

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ALIBIRD mHealth platform

Arm Description

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.

Outcomes

Primary Outcome Measures

Usability and feasibility assesment
Changes in Satisfaction System Usability Scale (SUS)

Secondary Outcome Measures

Changes in Mediterranean Diet Serving Score (MDSS)
Mediterranean adherence assesment
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.
Changes in physical activity (International Physical Activity Questionnaire,PAQ)
Physical activity assesment
Changes in sleep (Pittsburg questionnaire)
Sleep assesment
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.
Changes in toxicity (Patient-Reported Outcome version of the Common Terminology Criteria for Adverse Events, PRO-CTAE questionnaire)
Toxicity assesment
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.
Changes in Massachusetts General Hospital-Sexual Functioning Questionnaire (MGH-SFQ) from baseline
Sexuality assesment
Changes is medication adherence (MMAS-8 questionnaire)
Medication adherence assesment
Changes in belief in medication (Beliefs about Medicines Questionnaire,BMQ)
Belief in medication assesment

Full Information

First Posted
January 24, 2023
Last Updated
October 17, 2023
Sponsor
Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares
Collaborators
Hospital Infanta Sofia, Universidad Politecnica de Madrid, IMDEA Food, Instituto de Investigación en Ciencias de la Alimentación (CIAL)
search

1. Study Identification

Unique Protocol Identification Number
NCT05770869
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
November 5, 2021 (Actual)
Primary Completion Date
October 28, 2022 (Actual)
Study Completion Date
October 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares
Collaborators
Hospital Infanta Sofia, Universidad Politecnica de Madrid, IMDEA Food, Instituto de Investigación en Ciencias de la Alimentación (CIAL)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Neoplasms
Keywords
Active Treatment

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ALIBIRD mHealth platform
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
ALIBIRD mHealth platform
Intervention Description
Use of a mHealth platform to follow-up and empower cancer patients in the self-management of their own health.
Primary Outcome Measure Information:
Title
Usability and feasibility assesment
Description
Changes in Satisfaction System Usability Scale (SUS)
Time Frame
week 1 to 28
Secondary Outcome Measure Information:
Title
Changes in Mediterranean Diet Serving Score (MDSS)
Description
Mediterranean adherence assesment
Time Frame
Week 1 to 28
Title
Changes in Quality of life ( European Quality of Life-5 Dimensions 5 Levels questionnaire,EQ-5D-5L) from baseline
Description
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.
Time Frame
Week 1 to 28
Title
Changes in physical activity (International Physical Activity Questionnaire,PAQ)
Description
Physical activity assesment
Time Frame
Week 1 to 28
Title
Changes in sleep (Pittsburg questionnaire)
Description
Sleep assesment
Time Frame
Week 1 to 28
Title
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)
Description
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.
Time Frame
Week 1 to 28
Title
Changes in toxicity (Patient-Reported Outcome version of the Common Terminology Criteria for Adverse Events, PRO-CTAE questionnaire)
Description
Toxicity assesment
Time Frame
week 1 to 28
Title
Changes is Hospital Anxiety and Depression Questionnaire (HADs) from baseline
Description
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.
Time Frame
Week 1 to 28
Title
Changes in Massachusetts General Hospital-Sexual Functioning Questionnaire (MGH-SFQ) from baseline
Description
Sexuality assesment
Time Frame
Week 1 to 28
Title
Changes is medication adherence (MMAS-8 questionnaire)
Description
Medication adherence assesment
Time Frame
Week 1 to 28
Title
Changes in belief in medication (Beliefs about Medicines Questionnaire,BMQ)
Description
Belief in medication assesment
Time Frame
Week 1 to 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
María Sereno Moyano, Medicine
Organizational Affiliation
Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares
Official's Role
Principal Investigator
Facility Information:
Facility Name
Servicio de Oncología. Hospital Infanta Sofía
City
San Sebastián De Los Reyes
State/Province
Madrid
ZIP/Postal Code
28134
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

mHealth ALIBIRD: A Digital Health Care Model

We'll reach out to this number within 24 hrs