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Thoracic NeoplasmsNCT05770869

mHealth ALIBIRD: A Digital Health Care Model

A study testing ALIBIRD mHealth platform in people with Thoracic Neoplasms, run by Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Thoracic Neoplasms
What is being tested?
ALIBIRD mHealth platform
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSpain
Study dates
5 Nov 2021to 28 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Servicio de Oncología. Hospital Infanta Sofía

    San Sebastián de los Reyes, Madrid, 28134

Other trials in Spain

About this study

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)

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.

Read the 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.

Being tested
ALIBIRD mHealth platform
Keywords
Active Treatment
Medical subject headings
Thoracic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ALIBIRD mHealth platformDevice

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

Study groups in NCT05770869
Study groupRoleWhat they receive
ALIBIRD mHealth platformExperimentalParticipants 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.
Receives: Device: ALIBIRD mHealth platform

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Usability and feasibility assesment

    Changes in Satisfaction System Usability Scale (SUS)

    Measured: week 1 to 28

Secondary outcomes (10)

  1. Changes in Mediterranean Diet Serving Score (MDSS)

    Mediterranean adherence assesment

    Measured: Week 1 to 28

  2. 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.

    Measured: Week 1 to 28

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

    Physical activity assesment

    Measured: Week 1 to 28

  4. Changes in sleep (Pittsburg questionnaire)

    Sleep assesment

    Measured: Week 1 to 28

  5. 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.

    Measured: Week 1 to 28

  6. Changes in toxicity (Patient-Reported Outcome version of the Common Terminology Criteria for Adverse Events, PRO-CTAE questionnaire)

    Toxicity assesment

    Measured: week 1 to 28

  7. 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.

    Measured: Week 1 to 28

  8. Changes in Massachusetts General Hospital-Sexual Functioning Questionnaire (MGH-SFQ) from baseline

    Sexuality assesment

    Measured: Week 1 to 28

  9. Changes is medication adherence (MMAS-8 questionnaire)

    Medication adherence assesment

    Measured: Week 1 to 28

  10. Changes in belief in medication (Beliefs about Medicines Questionnaire,BMQ)

    Belief in medication assesment

    Measured: Week 1 to 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2023
  2. Study start5 Nov 2021
  3. Primary completion28 Oct 2022
  4. Study completion28 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05770869
Sponsor's protocol ID
mHA
Status last verified
Oct 2023
First submitted
24 Jan 2023
Last updated
18 Oct 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing ALIBIRD mHealth platform in people with Thoracic Neoplasms, run by Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Usability and feasibility assesment (time frame: week 1 to 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05770869.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.

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