Digital Solutions for bEtter cAre (ALTHEA)

February 16, 2026 updated by: European Institute of Oncology

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Caen, France
  • Germany
      • Homburg, Germany
        • Not yet recruiting
        • Saarland University
        • Contact:
  • Italy
    • Italy
      • Milan, Italy, Italy, 20141
        • Not yet recruiting
        • European Institute of Oncology
        • Contact:
  • Lithuania
      • Vilnius, Lithuania
        • Not yet recruiting
        • National Cancer Institute
        • Contact:
  • Spain
      • Barcelona, Spain
        • Not yet recruiting
        • Catalan Institute of Oncology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients, survivors, caregivers, family members and healthcare professionals
Focus group discussions (FGD) and completion of survey
Behavioral: Patients, survivors, caregivers, family members and healthcare professionals
Focus group discussions (FGD) and completion of survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of unmet needs of patients, caregivers and Health Care Professionals (HCPs)
Time Frame: 15 months
Number of unmet needs reported by patients, caregivers and Health Care Professionals (HCPs)
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Institute of Oncology

Collaborators

European Union

Investigators

  • Principal Investigator: Gabriella Pravettoni, MD, European Institute of Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

June 3, 2025

First Submitted That Met QC Criteria

February 16, 2026

First Posted (Actual)

February 18, 2026

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L2-293

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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