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Completed

NCT Number: NCT05770869

mHealth ALIBIRD: A Digital Health Care Model

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.

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Key information

Conditions

Thoracic Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Servicio de Oncología. Hospital Infanta Sofía

San Sebastián de los Reyes, Madrid, 28134, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ALIBIRD mHealth platform

Device

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

Primary outcomes

  1. Usability and feasibility assesment

    Time frame: week 1 to 28

    Changes in Satisfaction System Usability Scale (SUS)

Secondary outcomes

  1. Changes in Mediterranean Diet Serving Score (MDSS)

    Time frame: Week 1 to 28

    Mediterranean adherence assesment

  2. Changes in Quality of life ( European Quality of Life-5 Dimensions 5 Levels questionnaire,EQ-5D-5L) from baseline

    Time frame: Week 1 to 28

    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.

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

    Time frame: Week 1 to 28

    Physical activity assesment

  4. Changes in sleep (Pittsburg questionnaire)

    Time frame: Week 1 to 28

    Sleep assesment

  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)

    Time frame: Week 1 to 28

    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.

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

    Time frame: week 1 to 28

    Toxicity assesment

  7. Changes is Hospital Anxiety and Depression Questionnaire (HADs) from baseline

    Time frame: Week 1 to 28

    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.

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

    Time frame: Week 1 to 28

    Sexuality assesment

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

    Time frame: Week 1 to 28

    Medication adherence assesment

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

    Time frame: Week 1 to 28

    Belief in medication assesment

Sponsors and collaborators

Lead sponsor

Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares

Other

Collaborators

  • Hospital Infanta Sofia
  • IMDEA Food
  • Instituto de Investigación en Ciencias de la Alimentación (CIAL)
  • Universidad Politecnica de Madrid

Registry information

Official study 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)

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 16, 2023
Registry last updated
Oct 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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