Digital Solutions for bEtter cAre

NCT07416513 | Recruiting

• 1 other identifier: L2-293
• Study Type: interventional
• Target: 200
• Locations: 5 countries
• Sites: 5

Brief Summary

The target population includes cancer patients, caregivers, family members, healthcare providers and mental health specialists, who will be the primary end-users of the Althea platform. For patients, survivors, caregivers, and family members, the sample variables include age, gender, type and stage of disease, and time since the first diagnosis. The healthcare professionals that will be involved in this study are those who attend to oncological patients, with sample variables such as age, gender, professional role, and prior experience and training in oncology or psycho-oncology.

Conditions

Cancer Diagnosis

Outcome Measures

Primary Outcomes (1)

• Number of unmet needs of patients, caregivers and Health Care Professionals (HCPs)

  Number of unmet needs reported by patients, caregivers and Health Care Professionals (HCPs)

  15 months

Study Arms (1)

Patients, survivors, caregivers, family members and healthcare professionals

EXPERIMENTAL

Focus group discussions (FGD) and completion of survey

Behavioral: Patients, survivors, caregivers, family members and healthcare professionals

Interventions

Patients, survivors, caregivers, family members and healthcare professionals BEHAVIORAL

Focus group discussions (FGD) and completion of survey

Patients, survivors, caregivers, family members and healthcare professionals

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• HEALTHCARE PROFESSIONALS:
• Healthcare professionals actually working in oncology and/or psychooncology;
• Teachers of paediatric cancer patients.
• ADULT POPULATION:
• Patients with a current or previous cancer diagnosis
• Adequate language proficiency,
• Able to provide informed consent;
• PAEDIATRIC POPULATION:
• Older than 12 years of age;
• Patients with a current or previous cancer diagnosis;
• Adequate language proficiency;
• Legal guardians of paediatric cancer patients able to provide informed consent.
• CAREGIVERS:
• Caregivers and/or family members of cancer patients who lived or assist the loved ones with a current or previous cancer diagnosis in the cancer journey;
• Adequate language proficiency;

You may not qualify if:

• Healthcare professionals with limited oncology patient contact;
• Insufficient knowledge of the local language;
• Severe cognitive impairment, and/or mental disorders that prohibited their participation in the study or inadequate verbal skills that may render them incapable of informed consent (as evaluated by the clinician);
• Inability to understand the study materials (as evaluated by the clinician);
• Physical or psychological impairment that prohibits their participation in focus groups (as evaluated by the clinician).

Sponsors & Collaborators

• European Institute of Oncology: lead
• European Union: collaborator

Study Sites (5)

Centre François Baclesse

Caen, France

RECRUITING

Saarland University

Homburg, Germany

NOT YET RECRUITING

European Institute of Oncology

Milan, Italy, 20141, Italy

NOT YET RECRUITING

National Cancer Institute

Vilnius, Lithuania

NOT YET RECRUITING

Catalan Institute of Oncology

Barcelona, Spain

NOT YET RECRUITING

MeSH Terms

Interventions

Caregivers; Health Personnel

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Study Officials

• Gabriella Pravettoni, MD

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriella Pravettoni, MD

CONTACT

+390257489731; gabriella.pravettoni@ieo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: February 18, 2026
• Study Start: May 14, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

IT (1); ES (1); FR (1); LI (1); DE (1)