Digital tools to support cancer patients, caregivers, and oncology professionals

ALTHEA: tAckLing menTal Health Cancer Patients and Their Families: Digital Solutions for bEtter cAre

This project will test the Althea digital platform with cancer patients, survivors, caregivers, family members, and oncology professionals to see how well it supports care and psychosocial needs.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 12 Years and up
• Sex: All
• Sponsor: European Institute of Oncology (Academic / other)
• Locations: 5 sites (Caen and 4 other locations)
• Trial ID: NCT07416513 on ClinicalTrials.gov

What this trial studies

The project will deploy the Althea platform to adult and pediatric patients (older than 12), survivors, caregivers, family members, and oncology healthcare professionals at multiple European sites. The study will collect demographic, clinical, and professional variables such as age, gender, cancer type and stage, time since diagnosis, professional role, and prior oncology or psycho-oncology training to characterize end users. Participants will use the platform and provide feedback through structured questionnaires, usage metrics, and interviews to inform usability and feature refinement. The aim is to optimize the platform for clinical and psychosocial support rather than to test a therapeutic intervention.

Who should consider this trial

Good fit: Ideal participants are cancer patients (including those older than 12), survivors, caregivers, family members, and oncology/psycho-oncology professionals who speak the local language and can provide informed consent.

Not a fit: People with insufficient local language proficiency, those unable to provide consent, children under 12 for the pediatric arm, or individuals who cannot or will not use digital tools are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, Althea could improve access to psychosocial support and coordination of care for patients, caregivers, and oncology teams.

How similar studies have performed: Previous digital support platforms for cancer populations have shown mixed but generally promising results for improving psychosocial outcomes and care coordination.

Eligibility criteria

Inclusion Criteria:

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;
* Able to provide informed consent;
* Caregivers and/or family members of paediatric cancer patients under 12 years of age.

Exclusion Criteria:

* 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).

Where this trial is running

Caen and 4 other locations

• Centre François Baclesse — Caen, France (Recruiting)
• Saarland University — Homburg, Germany (Not_yet_recruiting)
• European Institute of Oncology — Milan, Italy, Italy (Not_yet_recruiting)
• National Cancer Institute — Vilnius, Lithuania (Not_yet_recruiting)
• Catalan Institute of Oncology — Barcelona, Spain (Not_yet_recruiting)

Study contacts

• Principal investigator: Gabriella Pravettoni, MD — European Institute of Oncology
• Study coordinator: Gabriella Pravettoni, MD

Conditions Cancer Diagnosis